Opioid-use DisorderNCT05042388
Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder
A study testing Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) and Treatment-As-Usual in people with Opioid-use Disorder, run by West Chester University of Pennsylvania at 1 site in United States.
Trial summary
This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) and Treatment-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An informed consent document voluntarily signed and dated by the subject.
- Subject must understand and be able to read and write in English.
- Enrollment in residential treatment at study site.
- Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
- Subject must be willing to be randomized to treatment condition.
- Subjects who are willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
- Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gaudenzia, Inc. (West Chester House)
West Chester, Pennsylvania, 19382
About this study
Official title: Mindful MAT Adherence: Mindfulness-Based Relapse Prevention (MBRP) to Improve Extended-release Naltrexone (XR-NTX) Adherence and Drug-use Outcomes for Opioid Use Disorder (OUD)
This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a ~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.
Read the detailed description
Medically detoxified OUD patients enrolling into a ~60-day residential program will be randomized to either MAT Treatment-As-Usual (TAU; n=100) or TAU+MBRP (MBRP; n=100) as part of their residential treatment and followed for 3-months post-discharge to assess MAT adherence and drug-use. All participants (n=200) will participate in residential TAU (i.e., MAT, supportive group therapy), and will be monitored following residential discharge to assess MAT adherence and drug-use relapse. Participants will complete assessments at baseline, post- treatment, and 1-, 2-, and 3-month follow-ups. Study Aims include:
AIM 1 (PRIMARY): Compare impact of TAU versus TAU+MBRP on medication adherence and drug-use outcomes. Hypotheses: Relative to TAU, TAU+MBRP participants will demonstrate a) greater MAT adherence measured at follow-up timepoints, and b) reduced drug-use (i.e., self-report, urine drug-screens [UDS]) measured at discharge and follow-up timepoints. AIM 2: Determine whether the beneficial effects of TAU+MBRP on outcome are mediated by improvements in opioid craving and dispositional mindfulness. Hypotheses: TAU+MBRP participants will report greater improvements in distress tolerance and mindfulness, relative to TAU, which will mediate treatment outcomes (i.e., MAT adherence, reduced drug use and positive-UDS). EXPLORATORY AIM 3: Determine effects of baseline factors on treatment outcomes. Hypotheses: More severe trauma exposure (i.e., increased number of traumas) and greater posttraumatic stress symptom severity will result in poorer treatment adherence (i.e., reduced MAT follow-up appointments) and worse drug-use outcomes (i.e., increased self-reported drug use, positive-urine drug-screens) throughout each the follow-up assessments among TAU participants but not among MBRP participants.
Study Design Overview: In an randomized controlled trial design, patients enrolling into a residential addiction treatment center will be randomized to TAU (i.e., MAT, supportive group therapy) or TAU+MBRP with comparisons being made between MBRP (n=100) and treatment-as-usual (TAU; n=100) on assessment measures collected at baseline, prior to residential discharge, and at 1, 2, and 3-month follow-up time points. To address AIM 1 (TAU+MBRP, Adherence and Drug-Use): participants will be randomly assigned to receive TAU or MBRP+TAU, during their residence within an inpatient treatment setting and will complete assessments at enrollment, prior to discharge, and at 1, 2, and 3-months follow-up to assess MAT adherence and drug-use. Comparisons, on assessment measures collected at follow-up, will be made between treatment conditions to determine if MBRP+TAU results in greater number MAT adherence, fewer positive UDS, reduced drug-craving, and increased mindfulness. AIM 2 (MBRP Mechanisms of Change): Will determine whether the beneficial effects of MBRP on treatment outcome (i.e., MAT adherence, drug-use) are mediated by increases in mindfulness and distress tolerance. AIM 3 (Predictors of MAT Adherence): will examine the extent to which prior trauma-exposure and PTSD symptom severity moderates MAT adherence and drug-use outcomes, among TAU participants (but not MBRP participants), following discharge from residential treatment.
- Conditions
- Opioid-use Disorder
- Being tested
- Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA), Treatment-As-Usual
- Keywords
- Addiction, Relapse Prevention, Opioid, Mindfulness
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)Behavioural
Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect.
Treatment-As-UsualBehavioural
Standard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) | Experimental | Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation. Receives: Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) |
| Treatment-As-Usual (TAU) | Active comparator | Standard procedure for residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on issues related to mental health and substance use disorders; and medication counseling. No aspect of the treatment-as-usual services provided entails mindfulness training or components of mindfulness training. Receives: Behavioral: Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Medication Assisted Treatment (MAT)
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Adherence to Medication Assisted Treatment (MAT)
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Adherence to Medication Assisted Treatment (MAT)
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Opioid Drug Use
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Opioid Drug Use
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Opioid Drug Use
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Opioid Craving
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Opioid Craving
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Measured: Assessed 1-month following discharge from residential addiction treatment facility (approximately 30 days post discharge)
Opioid Craving
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post discharge)
Opioid Craving
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post discharge)
Secondary outcomes (32)
Dispositional Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Dispositional Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Dispositional Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.
Measured: Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Dispositional Mindfulness
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.
Measured: Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Global Mental Health
Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Global Mental Health
Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Global Mental Health
Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Global Mental Health
Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Reward Probability
Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Reward Probability
Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Reward Probability
Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Reward Probability
Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Environmental Suppression
Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Abstinence Self-Efficacy
Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Abstinence Self-Efficacy
Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Abstinence Self-Efficacy
Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Abstinence Self-Efficacy
Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Posttraumatic Stress Severity
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Posttraumatic Stress Severity
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Posttraumatic Stress Severity
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Posttraumatic Stress Severity
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Trauma Symptoms of Discrimination
Trauma Symptoms of Discrimination Scale (TSDS; Williams, Printz, et al., 2018), 21-item self-report measure of dysfunctional anxiety and avoidance due to fears of discrimination. Higher scores = worse, greater distress related to discrimination; Range: 21-84. Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Treatment Engagement
Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Treatment Engagement
Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Treatment Engagement
Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Mindfulness of Craving
Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.
Measured: Assessed immediately prior to discharge from residential addiction treatment facility.
Mindfulness of Craving
Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.
Measured: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Mindfulness of Craving
Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.
Measured: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Mindfulness of Craving
Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.
Measured: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Aug 2021
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to 1 of 2 conditions: MBRP+TAU or TAU.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Chester University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Gawrysiak, West Chester University of Pennsylvania
- Investigators
- Michael J Gawrysiak, PhD, Principal investigator, West Chester University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042388
- Sponsor's protocol ID
- R15DA050102
- Other IDs
- 1R15DA050102-01A1
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2021
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all primary analyses and reports have been generated by the study PI to satisfy the aims of the research proposal, the PI will accept requests for components of the data to be available to other researchers for secondary analyses. When appropriate, the PI will share information necessary to foster productive collaborations.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful MAT Adherence: Mindfulness-Based Relapse Prevention (MBRP) to Improve Extended-release Naltrexone (XR-NTX) Adherence and Drug-use Outcomes for Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT05042388
- Acronym / sponsor ID
- R15DA050102
- Conditions
- Opioid-use Disorder
- Keywords
- Addiction, Relapse Prevention, Opioid, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- West Chester University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a ~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.
Detailed description
Medically detoxified OUD patients enrolling into a ~60-day residential program will be randomized to either MAT Treatment-As-Usual (TAU; n=100) or TAU+MBRP (MBRP; n=100) as part of their residential treatment and followed for 3-months post-discharge to assess MAT adherence and drug-use. All participants (n=200) will participate in residential TAU (i.e., MAT, supportive group therapy), and will be monitored following residential discharge to assess MAT adherence and drug-use relapse. Participants will complete assessments at baseline, post- treatment, and 1-, 2-, and 3-month follow-ups. Study Aims include:
AIM 1 (PRIMARY): Compare impact of TAU versus TAU+MBRP on medication adherence and drug-use outcomes. Hypotheses: Relative to TAU, TAU+MBRP participants will demonstrate a) greater MAT adherence measured at follow-up timepoints, and b) reduced drug-use (i.e., self-report, urine drug-screens [UDS]) measured at discharge and follow-up timepoints. AIM 2: Determine whether the beneficial effects of TAU+MBRP on outcome are mediated by improvements in opioid craving and dispositional mindfulness. Hypotheses: TAU+MBRP participants will report greater improvements in distress tolerance and mindfulness, relative to TAU, which will mediate treatment outcomes (i.e., MAT adherence, reduced drug use and positive-UDS). EXPLORATORY AIM 3: Determine effects of baseline factors on treatment outcomes. Hypotheses: More severe trauma exposure (i.e., increased number of traumas) and greater posttraumatic stress symptom severity will result in poorer treatment adherence (i.e., reduced MAT follow-up appointments) and worse drug-use outcomes (i.e., increased self-reported drug use, positive-urine drug-screens) throughout each the follow-up assessments among TAU participants but not among MBRP participants.
Study Design Overview: In an randomized controlled trial design, patients enrolling into a residential addiction treatment center will be randomized to TAU (i.e., MAT, supportive group therapy) or TAU+MBRP with comparisons being made between MBRP (n=100) and treatment-as-usual (TAU; n=100) on assessment measures collected at baseline, prior to residential discharge, and at 1, 2, and 3-month follow-up time points. To address AIM 1 (TAU+MBRP, Adherence and Drug-Use): participants will be randomly assigned to receive TAU or MBRP+TAU, during their residence within an inpatient treatment setting and will complete assessments at enrollment, prior to discharge, and at 1, 2, and 3-months follow-up to assess MAT adherence and drug-use. Comparisons, on assessment measures collected at follow-up, will be made between treatment conditions to determine if MBRP+TAU results in greater number MAT adherence, fewer positive UDS, reduced drug-craving, and increased mindfulness. AIM 2 (MBRP Mechanisms of Change): Will determine whether the beneficial effects of MBRP on treatment outcome (i.e., MAT adherence, drug-use) are mediated by increases in mindfulness and distress tolerance. AIM 3 (Predictors of MAT Adherence): will examine the extent to which prior trauma-exposure and PTSD symptom severity moderates MAT adherence and drug-use outcomes, among TAU participants (but not MBRP participants), following discharge from residential treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to 1 of 2 conditions: MBRP+TAU or TAU.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) | Experimental | Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation. |
| Treatment-As-Usual (TAU) | Active comparator | Behavioral: Treatment-As-UsualStandard procedure for residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on issues related to mental health and substance use disorders; and medication counseling. No aspect of the treatment-as-usual services provided entails mindfulness training or components of mindfulness training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An informed consent document voluntarily signed and dated by the subject.
- Subject must understand and be able to read and write in English.
- Enrollment in residential treatment at study site.
- Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
- Subject must be willing to be randomized to treatment condition.
Key exclusion criteria (2 listed)
- Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
- Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect. | Behavioural | Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) |
| Treatment-As-UsualStandard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling. | Behavioural | Treatment-As-Usual (TAU) |
Primary outcome
Adherence to Medication Assisted Treatment (MAT)
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Adherence to Medication Assisted Treatment (MAT)
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Adherence to Medication Assisted Treatment (MAT)
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Opioid Drug Use
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Opioid Drug Use
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Opioid Drug Use
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.
Opioid Craving
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Opioid Craving
Time frame: Assessed 1-month following discharge from residential addiction treatment facility (approximately 30 days post discharge)
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Opioid Craving
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post discharge)
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
Opioid Craving
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post discharge)
Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.
32 secondary outcomes
Dispositional Mindfulness
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Dispositional Mindfulness
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Dispositional Mindfulness
Time frame: Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Dispositional Mindfulness
Time frame: Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Global Mental Health
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Global Mental Health
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Global Mental Health
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Global Mental Health
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Reward Probability
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Reward Probability
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Reward Probability
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Reward Probability
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Environmental Suppression
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Environmental Suppression
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Abstinence Self-Efficacy
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Abstinence Self-Efficacy
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Abstinence Self-Efficacy
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Abstinence Self-Efficacy
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Posttraumatic Stress Severity
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Posttraumatic Stress Severity
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Posttraumatic Stress Severity
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Posttraumatic Stress Severity
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Trauma Symptoms of Discrimination
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Treatment Engagement
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Treatment Engagement
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Treatment Engagement
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Mindfulness of Craving
Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.
Mindfulness of Craving
Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Mindfulness of Craving
Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Mindfulness of Craving
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. After all primary analyses and reports have been generated by the study PI to satisfy the aims of the research proposal, the PI will accept requests for components of the data to be available to other researchers for secondary analyses. When appropriate, the PI will share information necessary to foster productive collaborations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Gawrysiak, PhD principal investigator
West Chester University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA) and Treatment-As-Usual in people with Opioid-use Disorder, run by West Chester University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Medication Assisted Treatment (MAT) (time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.