Opioid-use DisorderNCT04650386
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
A study testing Psychosocial support determined by adaptive treatment algorithm in people with Opioid-use Disorder, run by Public Health Management Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. 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?
- Psychosocial support determined by adaptive treatment algorithm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks;
- Not require an inpatient level of care as determined by the healthcare provider; and
- Be capable of providing valid contact information and informed consent.
Who cannot join
- Patient is under the age of 18;
- Co-morbid psychiatric disorder indicating the need for more intensive residential treatment
- Patient is unable to provide informed consent.
- Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Project HOME Stephen J. Klein Wellness Center
Philadelphia, Pennsylvania, 19121
PHMC Care Clinic
Philadelphia, Pennsylvania, 19123
About this study
Official title: Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach
The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.
Read the detailed description
This study will help to inform best practices for providing psychosocial treatment within the context of office-based opioid treatment (OBOT) with buprenorphine. We will use a staged approach to develop and evaluate an adaptive approach to the provision of adjunctive psychosocial treatment that includes medication management by a buprenorphine provider and linkage to CRSs and CBT depending on the needs of the patient. The specific aims of the proposal are listed below.
Aim 1: Work collaboratively with our multidisciplinary team to develop specific protocols for the CRS and CBT interventions and establish algorithms based on behavioral criteria to determine when each intervention should be implemented. As a part of this aim, we will also develop standard procedures for delivering each intervention and train interventionists [i.e., CRSs and Licensed Professional Counselors (LPCs)] to deliver them with fidelity.
Aim 2: Conduct a two-group randomized study to evaluate the efficacy of the adaptive intervention relative to TAU. Outcomes to be examined will include urinalysis-confirmed opioid use, retention in buprenorphine- based OBOT, quality of life, and psychosocial functioning through one year post-study entry.
Aim 3: Conduct a qualitative evaluation of the intervention and develop a strategic plan for its dissemination. We will conduct focus groups with clinic staff and relevant stakeholders to determine the utility and acceptability of the adaptive intervention. In addition, we will hold an expert roundtable to identify mechanisms for increasing sustainability and enhancing adoption by other office-based buprenorphine programs to inform the development of the strategic plan.
Aim 4: Establish a training program in clinical research for minority students. Eight undergraduate students from a historically minority higher education institution will be selected to participate in 9-month internships during which they will receive comprehensive and pragmatic training in the full range of clinical research from study design to dissemination.
- Conditions
- Opioid-use Disorder
- Being tested
- Psychosocial support determined by adaptive treatment algorithm
- Keywords
- Opioid Use, Medication Assisted Treatment, Psychosocial Treatment, Cognitive Behavioral Therapy, Peer Support, Peer Recovery Specialist, Certified Recovery Specialist, Opioid Use Disorder, Adaptive Intervention, Office-Based Opioid Treatment, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial support determined by adaptive treatment algorithmBehavioural
Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | Participants assigned to the TAU condition will be scheduled for buprenorphine medication management appointments and will receive OBOT at the FQHC and adjunctive psychosocial treatment as typically provided at the FQHC. The team will continue to meet with the patient during subsequent MAT visits on a decreasing frequency, with some slight site-specific variation. The schedule of MAT visits generally includes 3 clinic visits during the week of induction, 1-2 visits per week until the patient is stabilized, and monthly thereafter. Behavioral health clinicians provide support to the patient, discuss UDS results, assist with strategic problem-solving around recovery and adjustment to sobriety, and monitor the patient's engagement in MAT. |
| Adaptive Intervention | Experimental | Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period. Receives: Behavioral: Psychosocial support determined by adaptive treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinalysis-confirmed abstinence from opioids at 3 month follow up
Participants will provide a urine specimen at the 3 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Measured: 3 months post study entry
Urinalysis-confirmed abstinence from opioids at 6 month follow up
Participants will provide a urine specimen at the 6 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Measured: 6 months post study entry
Urinalysis-confirmed abstinence from opioids at 9 month follow up
Participants will provide a urine specimen at the 9 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Measured: 9 months post study entry
Urinalysis-confirmed abstinence from opioids at 12 month follow up
Participants will provide a urine specimen at the 12 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Measured: 12 months post study entry
Secondary outcomes (5)
Abstinence from or reductions in use of other (non-opioid) psychoactive substances
Results from the CLIAwaived® 14-panel test and fentanyl strip described above for the primary outcome will be used as an indicator of this outcome.
Measured: Through 12 months post-study entry
Retention in buprenorphine-based OBOT
Including appointment attendance, medication and treatment adherence, and retention in and completion of treatment.
Measured: Through 12 months post-study entry
Quality of life assessment
Quality of life will be measured using the Short Form-36 (SF-36). The SF-36 is a self-report inventory that assesses eight dimensions of physical and mental health-related quality of life. The SF-36 has been shown to have high reliability and validity.
Measured: Through 12 months post-study entry
Psychosocial functioning/Multidimensional problem severity
Multidimensional problem severity, a secondary outcome, will be measured using the Addiction Severity Index-Lite (ASI-Lite). The ASI-Lite is a reliable and valid multidimensional assessment that provides composite scores reflecting current problem severity in the medical, employment, alcohol, drug, legal, family/social, and psychiatric areas.
Measured: Through 12 months post-study entry
Treatment satisfaction
Treatment satisfaction will be measured using a modified version of the Treatment Services Review (TSR). The TSR measures patient therapeutic engagement in and satisfaction with treatment.
Measured: Through 12 months post-study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start21 Sep 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (94)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Management Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Karen Dugosh, Ph.D., Principal investigator, PHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650386
- Sponsor's protocol ID
- 1908
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005031. doi: 10.1002/14651858.CD005031.pub4.
PubMed 21901695Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
PubMed 21403039Andraka-Christou B, Capone MJ. A qualitative study comparing physician-reported barriers to treating addiction using buprenorphine and extended-release naltrexone in U.S. office-based practices. Int J Drug Policy. 2018 Apr;54:9-17. doi: 10.1016/j.drugpo.2017.11.021. Epub 2018 Jan 8.
PubMed 29324253Araya R, Rojas G, Fritsch R, Gaete J, Rojas M, Simon G, Peters TJ. Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial. Lancet. 2003 Mar 22;361(9362):995-1000. doi: 10.1016/S0140-6736(03)12825-5.
PubMed 12660056Barry DT, Irwin KS, Jones ES, Becker WC, Tetrault JM, Sullivan LE, Hansen H, O'Connor PG, Schottenfeld RS, Fiellin DA. Integrating buprenorphine treatment into office-based practice: a qualitative study. J Gen Intern Med. 2009 Feb;24(2):218-25. doi: 10.1007/s11606-008-0881-9. Epub 2008 Dec 17.
PubMed 19089500Bassuk EL, Hanson J, Greene RN, Richard M, Laudet A. Peer-Delivered Recovery Support Services for Addictions in the United States: A Systematic Review. J Subst Abuse Treat. 2016 Apr;63:1-9. doi: 10.1016/j.jsat.2016.01.003. Epub 2016 Jan 13.
PubMed 26882891Beck AT. Cognitive therapy : nature and relation to behavior therapy. J Psychother Pract Res. 1993 Fall;2(4):342-56. No abstract available.
PubMed 22700159Breslin FC, Sobell MB, Sobell LC, Cunningham JA, Sdao-Jarvie K, Borsoi D. Problem drinkers: evaluation of a stepped-care approach. J Subst Abuse. 1998;10(3):217-32. doi: 10.1016/s0899-3289(99)00008-5.
PubMed 10689656Brooner RK, Kidorf M. Using behavioral reinforcement to improve methadone treatment participation. Sci Pract Perspect. 2002 Jul;1(1):38-47. doi: 10.1151/spp021138.
PubMed 18567965Brooner RK, Kidorf MS, King VL, Stoller KB, Peirce JM, Bigelow GE, Kolodner K. Behavioral contingencies improve counseling attendance in an adaptive treatment model. J Subst Abuse Treat. 2004 Oct;27(3):223-32. doi: 10.1016/j.jsat.2004.07.005.
PubMed 15501375Brooner RK, Kidorf MS, King VL, Stoller KB, Neufeld KJ, Kolodner K. Comparing adaptive stepped care and monetary-based voucher interventions for opioid dependence. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S14-23. doi: 10.1016/j.drugalcdep.2006.12.006. Epub 2007 Jan 24.
PubMed 17257782Cacciola JS, Alterman AI, McLellan AT, Lin YT, Lynch KG. Initial evidence for the reliability and validity of a "Lite" version of the Addiction Severity Index. Drug Alcohol Depend. 2007 Mar 16;87(2-3):297-302. doi: 10.1016/j.drugalcdep.2006.09.002. Epub 2006 Oct 11.
PubMed 17045423Carels RA, Darby L, Cacciapaglia HM, Douglass OM, Harper J, Kaplar ME, Konrad K, Rydin S, Tonkin K. Applying a stepped-care approach to the treatment of obesity. J Psychosom Res. 2005 Dec;59(6):375-83. doi: 10.1016/j.jpsychores.2005.06.060.
PubMed 16310019Choi NG, DiNitto DM, Marti CN. Treatment use, perceived need, and barriers to seeking treatment for substance abuse and mental health problems among older adults compared to younger adults. Drug Alcohol Depend. 2014 Dec 1;145:113-20. doi: 10.1016/j.drugalcdep.2014.10.004. Epub 2014 Oct 16.
PubMed 25456572Collins LM, Murphy SA, Bierman KL. A conceptual framework for adaptive preventive interventions. Prev Sci. 2004 Sep;5(3):185-96. doi: 10.1023/b:prev.0000037641.26017.00.
PubMed 15470938
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach
- ClinicalTrials.gov ID
- NCT04650386
- Acronym / sponsor ID
- 1908
- Conditions
- Opioid-use Disorder
- Keywords
- Opioid Use, Medication Assisted Treatment, Psychosocial Treatment, Cognitive Behavioral Therapy, Peer Support, Peer Recovery Specialist, Certified Recovery Specialist, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Public Health Management CorporationUniversity, hospital or other
- Collaborators
- Philadelphia College of Osteopathic Medicine, University of Pennsylvania
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.
Detailed description
This study will help to inform best practices for providing psychosocial treatment within the context of office-based opioid treatment (OBOT) with buprenorphine. We will use a staged approach to develop and evaluate an adaptive approach to the provision of adjunctive psychosocial treatment that includes medication management by a buprenorphine provider and linkage to CRSs and CBT depending on the needs of the patient. The specific aims of the proposal are listed below.
Aim 1: Work collaboratively with our multidisciplinary team to develop specific protocols for the CRS and CBT interventions and establish algorithms based on behavioral criteria to determine when each intervention should be implemented. As a part of this aim, we will also develop standard procedures for delivering each intervention and train interventionists [i.e., CRSs and Licensed Professional Counselors (LPCs)] to deliver them with fidelity.
Aim 2: Conduct a two-group randomized study to evaluate the efficacy of the adaptive intervention relative to TAU. Outcomes to be examined will include urinalysis-confirmed opioid use, retention in buprenorphine- based OBOT, quality of life, and psychosocial functioning through one year post-study entry.
Aim 3: Conduct a qualitative evaluation of the intervention and develop a strategic plan for its dissemination. We will conduct focus groups with clinic staff and relevant stakeholders to determine the utility and acceptability of the adaptive intervention. In addition, we will hold an expert roundtable to identify mechanisms for increasing sustainability and enhancing adoption by other office-based buprenorphine programs to inform the development of the strategic plan.
Aim 4: Establish a training program in clinical research for minority students. Eight undergraduate students from a historically minority higher education institution will be selected to participate in 9-month internships during which they will receive comprehensive and pragmatic training in the full range of clinical research from study design to dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –Participants assigned to the TAU condition will be scheduled for buprenorphine medication management appointments and will receive OBOT at the FQHC and adjunctive psychosocial treatment as typically provided at the FQHC. The team will continue to meet with the patient during subsequent MAT visits on a decreasing frequency, with some slight site-specific variation. The schedule of MAT visits generally includes 3 clinic visits during the week of induction, 1-2 visits per week until the patient is stabilized, and monthly thereafter. Behavioral health clinicians provide support to the patient, discuss UDS results, assist with strategic problem-solving around recovery and adjustment to sobriety, and monitor the patient's engagement in MAT. |
| Adaptive Intervention | Experimental | Behavioral: Psychosocial support determined by adaptive treatment algorithmParticipants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks;
- Not require an inpatient level of care as determined by the healthcare provider; and
- Be capable of providing valid contact information and informed consent.
Key exclusion criteria (4 listed)
- Patient is under the age of 18;
- Co-morbid psychiatric disorder indicating the need for more intensive residential treatment
- Patient is unable to provide informed consent.
- Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.
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 |
|---|---|---|
| Psychosocial support determined by adaptive treatment algorithmParticipants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period. | Behavioural | Adaptive Intervention |
Primary outcome
Urinalysis-confirmed abstinence from opioids at 3 month follow up
Time frame: 3 months post study entry
Participants will provide a urine specimen at the 3 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 6 month follow up
Time frame: 6 months post study entry
Participants will provide a urine specimen at the 6 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 9 month follow up
Time frame: 9 months post study entry
Participants will provide a urine specimen at the 9 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Urinalysis-confirmed abstinence from opioids at 12 month follow up
Time frame: 12 months post study entry
Participants will provide a urine specimen at the 12 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
5 secondary outcomes
Abstinence from or reductions in use of other (non-opioid) psychoactive substances
Time frame: Through 12 months post-study entry
Retention in buprenorphine-based OBOT
Time frame: Through 12 months post-study entry
Quality of life assessment
Time frame: Through 12 months post-study entry
Psychosocial functioning/Multidimensional problem severity
Time frame: Through 12 months post-study entry
Treatment satisfaction
Time frame: Through 12 months post-study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 21901695Amato L, Minozzi S, Davoli M, Vecchi S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005031. doi: 10.1002/14651858.CD005031.pub4.
- Background: PubMed 21403039Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
- Background: PubMed 29324253Andraka-Christou B, Capone MJ. A qualitative study comparing physician-reported barriers to treating addiction using buprenorphine and extended-release naltrexone in U.S. office-based practices. Int J Drug Policy. 2018 Apr;54:9-17. doi: 10.1016/j.drugpo.2017.11.021. Epub 2018 Jan 8.
- Background: PubMed 12660056Araya R, Rojas G, Fritsch R, Gaete J, Rojas M, Simon G, Peters TJ. Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial. Lancet. 2003 Mar 22;361(9362):995-1000. doi: 10.1016/S0140-6736(03)12825-5.
- Background: PubMed 19089500Barry DT, Irwin KS, Jones ES, Becker WC, Tetrault JM, Sullivan LE, Hansen H, O'Connor PG, Schottenfeld RS, Fiellin DA. Integrating buprenorphine treatment into office-based practice: a qualitative study. J Gen Intern Med. 2009 Feb;24(2):218-25. doi: 10.1007/s11606-008-0881-9. Epub 2008 Dec 17.
- Background: PubMed 26882891Bassuk EL, Hanson J, Greene RN, Richard M, Laudet A. Peer-Delivered Recovery Support Services for Addictions in the United States: A Systematic Review. J Subst Abuse Treat. 2016 Apr;63:1-9. doi: 10.1016/j.jsat.2016.01.003. Epub 2016 Jan 13.
- Background: PubMed 22700159Beck AT. Cognitive therapy : nature and relation to behavior therapy. J Psychother Pract Res. 1993 Fall;2(4):342-56. No abstract available.
- Background: PubMed 10689656Breslin FC, Sobell MB, Sobell LC, Cunningham JA, Sdao-Jarvie K, Borsoi D. Problem drinkers: evaluation of a stepped-care approach. J Subst Abuse. 1998;10(3):217-32. doi: 10.1016/s0899-3289(99)00008-5.
- Background: PubMed 18567965Brooner RK, Kidorf M. Using behavioral reinforcement to improve methadone treatment participation. Sci Pract Perspect. 2002 Jul;1(1):38-47. doi: 10.1151/spp021138.
- Background: PubMed 15501375Brooner RK, Kidorf MS, King VL, Stoller KB, Peirce JM, Bigelow GE, Kolodner K. Behavioral contingencies improve counseling attendance in an adaptive treatment model. J Subst Abuse Treat. 2004 Oct;27(3):223-32. doi: 10.1016/j.jsat.2004.07.005.
- Background: PubMed 17257782Brooner RK, Kidorf MS, King VL, Stoller KB, Neufeld KJ, Kolodner K. Comparing adaptive stepped care and monetary-based voucher interventions for opioid dependence. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S14-23. doi: 10.1016/j.drugalcdep.2006.12.006. Epub 2007 Jan 24.
- Background: PubMed 17045423Cacciola JS, Alterman AI, McLellan AT, Lin YT, Lynch KG. Initial evidence for the reliability and validity of a "Lite" version of the Addiction Severity Index. Drug Alcohol Depend. 2007 Mar 16;87(2-3):297-302. doi: 10.1016/j.drugalcdep.2006.09.002. Epub 2006 Oct 11.
- Individual participant dataSharing planned: No
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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.
Karen Dugosh, Ph.D. principal investigator
PHMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial support determined by adaptive treatment algorithm in people with Opioid-use Disorder, run by Public Health Management Corporation at 2 sites 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 3 inclusion and 4 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinalysis-confirmed abstinence from opioids at 3 month follow up (time frame: 3 months post study entry). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650386, which also lists 94 linked publications.
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 6 Nov 2024.