Alcohol Use DisorderABQTREATNCT03842670
Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder
A study testing Cognitive Behavior Therapy and Mindfulness Based Relapse Prevention in people with Alcohol Use Disorder and Alcohol Abuse, run by University of New Mexico at 2 sites in United States.
Trial summary
Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Abuse, Alcohol Drinking
- What is being tested?
- Cognitive Behavior Therapy and Mindfulness Based Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2018to 31 Mar 2025
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22-85 years
- Self-identify as a heavy/binge/weekly drinker
- Engage in "hazardous and harmful alcohol use" (Babor et al., 2001) based on an AUDIT score > 8 for men and > 7 for women
- Breath alcohol level of 0.00 at in-person screening
- Right handed
- Explicitly be seeking help for their drinking
- Alcohol use during the past 30 days
Who cannot join
- History of brain injury or neurological diagnoses
- Evidence of current psychosis
- Past-year substance dependence other than nicotine or marijuana
- Evidence of recent illicit drug (other than marijuana) use on a urine screen
- Contraindications for MRI (e.g., medical devices in the body)
- Female participants who think they may be pregnant must pass a urine pregnancy screen prior to each MRI scanning session
Show all 10Show fewer
- Estimated IQ < 80
- Unable to read or speak English fluently
- History of major alcohol withdrawal
- Currently in treatment for alcohol use (or within the past 6 months)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Mind Research Network
Albuquerque, New Mexico, 87106
The University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological
Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change.
The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions.
It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.
Read the detailed description
Although pharmacological and psychosocial treatments for alcohol use disorders (AUDs) exist that improve outcomes over natural recovery (Finney et al., 2013), outcomes are still modest. Identifying mechanisms of behavior change (MOBCs) that lead to successful outcomes may be critical for efforts to improve existing treatments or to better match patients with particular treatments. The goal of the proposed research is to conduct a randomized clinical trial to systematically examine pretreatment neurocognitive and behavioral characteristics and changes in brain function over time during two empirically supported treatments for AUD. One hundred forty treatment-seeking individuals with an AUD will be randomized to receive either 8 weeks of Cognitive Behavioral Treatment (CBT) or Mindfulness Based Treatment (MBT) after receiving 4 weeks of a platform treatment that focuses on enhancing motivation to change. Neurocognitive and behavioral characteristics will be measured using neuroimaging, comprehensive behavioral assessments, and patient self-reports. To establish the temporal relationship between changes in drinking and changes in these MOBCs, patients will be assessed at: (a) baseline; (b) four weeks into treatment; (c) immediately post-treatment; and (d) 9- and 15-months post-baseline. Self-report measures and behavioral tasks will be administered at monthly intervals during treatment; and fMRI will be collected at baseline, and at 3, and 9-months post baseline. The primary aim of the study is to examine the effects of the treatments on three hypothesized mechanisms: craving/regulation of craving, cognitive and behavioral control, and regulation of affect/arousal. The secondary aim will identify neurocognitive and behavioral baseline characteristics predictive of reductions in drinking over time and differential patterns of response to CBT or MBT.
- Being tested
- Cognitive Behavior Therapy, Mindfulness Based Relapse Prevention
- Keywords
- Alcohol Use Disorder, Behavioral Treatment, Mechanisms of behavior change, Neuroimaging
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein \& McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.
Mindfulness Based Relapse PreventionBehavioural
The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz \& Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavior Therapy | Active comparator | The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein \& McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. Receives: Behavioral: Cognitive Behavior Therapy |
| Mindfulness Based Relapse Prevention | Active comparator | The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz \& Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. Receives: Behavioral: Mindfulness Based Relapse Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent heavy drinking days
The Form 90 will be used to derive estimates of the outcome: percent heavy drinking days, where heavy drinking is defined as 4+ drinks per occasion for women and 5+ drinks per occasion for men.
Measured: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
Secondary outcomes (10)
Percent drinking days
The Form 90 will be used to derive estimates of the outcome percent drinking days.
Measured: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
MOBC: Craving - self report
The Penn Alcohol Craving Scale will be used to examine changes in craving that occur during and after treatment. Ratings range from 1-6, with higher scores indicating a higher level of craving.
Measured: Up to 15 months
MOBC: Regulation of Affect/Arousal - negative affect self-report
The Negative Affect Summary score from the National Institutes of Health Negative Emotions toolbox will be used to assess overall negative affect changes during and after treatment. T-scores on the measure can range from 1-100, with higher scores indicating a higher level of negative affect.
Measured: Up to 15 months
MOBC: Regulation of Affect/Arousal - neuroimaging
The difference in percent signal change during negative vs. neutral picture cues in amygdala will be assessed using a cue task while participants are scanned using functional magnetic resonance imaging.
Measured: Up to 9 months
MOBC: Cognitive and Behavioral Control - neuroimaging errors
The difference in percent signal change during unsuccessful inhibition of responses vs. successful non-inhibition trials in dorsal anterior cingulate cortex will be assessed using a stop signal task while participants are scanned using functional magnetic resonance imaging.
Measured: Up to 9 months
MOBC: Cognitive and Behavioral Control - neuroimaging inhibition
The difference in percent signal change during successful inhibition of responses vs. successful non-inhibition trials in right inferior frontal cortex will be assessed using a stop signal task while participants are scanned using functional magnetic resonance imaging.
Measured: Up to 9 months
MOBC: Cognitive and Behavioral Control - behavior
The Monetary Choice Questionnaire will be used to determine the degree to which impulsive choice changes during and after treatment. A discounting rate (k) will be computed for each administration.
Measured: Up to 15 months
MOBC: Cognitive and Behavioral Control - self report impulsivity
The UPPS-P Impulsive Behavior Scale will be used to examine changes in impulsivity that occur during and after treatment. Potential total scores range from 59-236, with higher scores indicating a higher level of impulsivity.
Measured: Up to 15 months
MOBC: Craving - neuroimaging
The difference in percent signal change during alcohol vs. neutral picture cues in ventral striatum will be assessed using a cue task while participants are scanned using functional magnetic resonance imaging
Measured: Up to 9 months
Drinks per drinking day
The Form 90 will be used to derive estimates of the outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.
Measured: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Nov 2018
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (106)Papers the sponsor has linked to this study.
- Other trials for Alcohol 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Mind Research Network
- Responsible party
- Principal investigator, Barbara S McCrady, PhD, University of New Mexico
- Investigators
- Barbara McCrady, PhD, Principal investigator, The University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842670
- Sponsor's protocol ID
- 1240557-4
- Acronym
- ABQTREAT
- Status last verified
- Apr 2025
- First submitted
- 6 Feb 2019
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aiken, L. S., West, S. G., & Reno, R. R. (1991). Multiple regression: Testing and interpreting interactions. Sage.
Allen EA, Erhardt EB, Damaraju E, Gruner W, Segall JM, Silva RF, Havlicek M, Rachakonda S, Fries J, Kalyanam R, Michael AM, Caprihan A, Turner JA, Eichele T, Adelsheim S, Bryan AD, Bustillo J, Clark VP, Feldstein Ewing SW, Filbey F, Ford CC, Hutchison K, Jung RE, Kiehl KA, Kodituwakku P, Komesu YM, Mayer AR, Pearlson GD, Phillips JP, Sadek JR, Stevens M, Teuscher U, Thoma RJ, Calhoun VD. A baseline for the multivariate comparison of resting-state networks. Front Syst Neurosci. 2011 Feb 4;5:2. doi: 10.3389/fnsys.2011.00002. eCollection 2011.
PubMed 21442040Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
PubMed 21818162Babor, T., Higgins-Biddle, J. C., Saunders, J. B., & Monteiro, M. G. (2001). AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary care, Second edition. Department of Mental Health and Substance Dependence, World Health Organization.
Bechara A, Damasio H. Decision-making and addiction (part I): impaired activation of somatic states in substance dependent individuals when pondering decisions with negative future consequences. Neuropsychologia. 2002;40(10):1675-89. doi: 10.1016/s0028-3932(02)00015-5.
PubMed 11992656Bechara A, Dolan S, Hindes A. Decision-making and addiction (part II): myopia for the future or hypersensitivity to reward? Neuropsychologia. 2002;40(10):1690-705. doi: 10.1016/s0028-3932(02)00016-7.
PubMed 11992657Bell AJ, Sejnowski TJ. An information-maximization approach to blind separation and blind deconvolution. Neural Comput. 1995 Nov;7(6):1129-59. doi: 10.1162/neco.1995.7.6.1129.
PubMed 7584893Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
PubMed 19904665Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.
PubMed 24647726Brewer JA, Bowen S, Smith JT, Marlatt GA, Potenza MN. Mindfulness-based treatments for co-occurring depression and substance use disorders: what can we learn from the brain? Addiction. 2010 Oct;105(10):1698-706. doi: 10.1111/j.1360-0443.2009.02890.x.
PubMed 20331548Calhoun VD, Adali T. Multisubject independent component analysis of fMRI: a decade of intrinsic networks, default mode, and neurodiagnostic discovery. IEEE Rev Biomed Eng. 2012;5:60-73. doi: 10.1109/RBME.2012.2211076.
PubMed 23231989Calhoun VD, Adali T, Pearlson GD, Pekar JJ. A method for making group inferences from functional MRI data using independent component analysis. Hum Brain Mapp. 2001 Nov;14(3):140-51. doi: 10.1002/hbm.1048.
PubMed 11559959Cardenas VA, Studholme C, Gazdzinski S, Durazzo TC, Meyerhoff DJ. Deformation-based morphometry of brain changes in alcohol dependence and abstinence. Neuroimage. 2007 Feb 1;34(3):879-87. doi: 10.1016/j.neuroimage.2006.10.015. Epub 2006 Nov 28.
PubMed 17127079Charlet K, Beck A, Jorde A, Wimmer L, Vollstadt-Klein S, Gallinat J, Walter H, Kiefer F, Heinz A. Increased neural activity during high working memory load predicts low relapse risk in alcohol dependence. Addict Biol. 2014 May;19(3):402-14. doi: 10.1111/adb.12103. Epub 2013 Oct 22.
PubMed 24147643Charlet K, Schlagenhauf F, Richter A, Naundorf K, Dornhof L, Weinfurtner CE, Konig F, Walaszek B, Schubert F, Muller CA, Gutwinski S, Seissinger A, Schmitz L, Walter H, Beck A, Gallinat J, Kiefer F, Heinz A. Neural activation during processing of aversive faces predicts treatment outcome in alcoholism. Addict Biol. 2014 May;19(3):439-51. doi: 10.1111/adb.12045. Epub 2013 Mar 7.
PubMed 23469861
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological
- ClinicalTrials.gov ID
- NCT03842670
- Acronym / sponsor ID
- ABQTREAT / 1240557-4
- Keywords
- Alcohol Use Disorder, Behavioral Treatment, Mechanisms of behavior change, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Mind Research Network
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Feb 2019 (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.
Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change.
The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions.
It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.
Detailed description
Although pharmacological and psychosocial treatments for alcohol use disorders (AUDs) exist that improve outcomes over natural recovery (Finney et al., 2013), outcomes are still modest. Identifying mechanisms of behavior change (MOBCs) that lead to successful outcomes may be critical for efforts to improve existing treatments or to better match patients with particular treatments. The goal of the proposed research is to conduct a randomized clinical trial to systematically examine pretreatment neurocognitive and behavioral characteristics and changes in brain function over time during two empirically supported treatments for AUD. One hundred forty treatment-seeking individuals with an AUD will be randomized to receive either 8 weeks of Cognitive Behavioral Treatment (CBT) or Mindfulness Based Treatment (MBT) after receiving 4 weeks of a platform treatment that focuses on enhancing motivation to change. Neurocognitive and behavioral characteristics will be measured using neuroimaging, comprehensive behavioral assessments, and patient self-reports. To establish the temporal relationship between changes in drinking and changes in these MOBCs, patients will be assessed at: (a) baseline; (b) four weeks into treatment; (c) immediately post-treatment; and (d) 9- and 15-months post-baseline. Self-report measures and behavioral tasks will be administered at monthly intervals during treatment; and fMRI will be collected at baseline, and at 3, and 9-months post baseline. The primary aim of the study is to examine the effects of the treatments on three hypothesized mechanisms: craving/regulation of craving, cognitive and behavioral control, and regulation of affect/arousal. The secondary aim will identify neurocognitive and behavioral baseline characteristics predictive of reductions in drinking over time and differential patterns of response to CBT or MBT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavior Therapy | Active comparator | Behavioral: Cognitive Behavior TherapyThe CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein \& McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. |
| Mindfulness Based Relapse Prevention | Active comparator | Behavioral: Mindfulness Based Relapse PreventionThe MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz \& Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 22-85 years
- Self-identify as a heavy/binge/weekly drinker
- Engage in "hazardous and harmful alcohol use" (Babor et al., 2001) based on an AUDIT score > 8 for men and > 7 for women
- Breath alcohol level of 0.00 at in-person screening
- Right handed
Key exclusion criteria (10 listed)
- History of brain injury or neurological diagnoses
- Evidence of current psychosis
- Past-year substance dependence other than nicotine or marijuana
- Evidence of recent illicit drug (other than marijuana) use on a urine screen
- Contraindications for MRI (e.g., medical devices in the body)
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 |
|---|---|---|
| Cognitive Behavior TherapyThe CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein \& McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended. | Behavioural | Cognitive-Behavior Therapy |
| Mindfulness Based Relapse PreventionThe MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz \& Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended. | Behavioural | Mindfulness Based Relapse Prevention |
Primary outcome
Percent heavy drinking days
Time frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
The Form 90 will be used to derive estimates of the outcome: percent heavy drinking days, where heavy drinking is defined as 4+ drinks per occasion for women and 5+ drinks per occasion for men.
10 secondary outcomes
Percent drinking days
Time frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
MOBC: Craving - self report
Time frame: Up to 15 months
MOBC: Regulation of Affect/Arousal - negative affect self-report
Time frame: Up to 15 months
MOBC: Regulation of Affect/Arousal - neuroimaging
Time frame: Up to 9 months
MOBC: Cognitive and Behavioral Control - neuroimaging errors
Time frame: Up to 9 months
MOBC: Cognitive and Behavioral Control - neuroimaging inhibition
Time frame: Up to 9 months
MOBC: Cognitive and Behavioral Control - behavior
Time frame: Up to 15 months
MOBC: Cognitive and Behavioral Control - self report impulsivity
Time frame: Up to 15 months
MOBC: Craving - neuroimaging
Time frame: Up to 9 months
Drinks per drinking day
Time frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up
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 22 Apr 2025.
- BackgroundAiken, L. S., West, S. G., & Reno, R. R. (1991). Multiple regression: Testing and interpreting interactions. Sage.
- Background: PubMed 21442040Allen EA, Erhardt EB, Damaraju E, Gruner W, Segall JM, Silva RF, Havlicek M, Rachakonda S, Fries J, Kalyanam R, Michael AM, Caprihan A, Turner JA, Eichele T, Adelsheim S, Bryan AD, Bustillo J, Clark VP, Feldstein Ewing SW, Filbey F, Ford CC, Hutchison K, Jung RE, Kiehl KA, Kodituwakku P, Komesu YM, Mayer AR, Pearlson GD, Phillips JP, Sadek JR, Stevens M, Teuscher U, Thoma RJ, Calhoun VD. A baseline for the multivariate comparison of resting-state networks. Front Syst Neurosci. 2011 Feb 4;5:2. doi: 10.3389/fnsys.2011.00002. eCollection 2011.
- Background: PubMed 21818162Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
- BackgroundBabor, T., Higgins-Biddle, J. C., Saunders, J. B., & Monteiro, M. G. (2001). AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary care, Second edition. Department of Mental Health and Substance Dependence, World Health Organization.
- Background: PubMed 11992656Bechara A, Damasio H. Decision-making and addiction (part I): impaired activation of somatic states in substance dependent individuals when pondering decisions with negative future consequences. Neuropsychologia. 2002;40(10):1675-89. doi: 10.1016/s0028-3932(02)00015-5.
- Background: PubMed 11992657Bechara A, Dolan S, Hindes A. Decision-making and addiction (part II): myopia for the future or hypersensitivity to reward? Neuropsychologia. 2002;40(10):1690-705. doi: 10.1016/s0028-3932(02)00016-7.
- Background: PubMed 7584893Bell AJ, Sejnowski TJ. An information-maximization approach to blind separation and blind deconvolution. Neural Comput. 1995 Nov;7(6):1129-59. doi: 10.1162/neco.1995.7.6.1129.
- Background: PubMed 19904665Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
- Background: PubMed 24647726Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.
- Background: PubMed 20331548Brewer JA, Bowen S, Smith JT, Marlatt GA, Potenza MN. Mindfulness-based treatments for co-occurring depression and substance use disorders: what can we learn from the brain? Addiction. 2010 Oct;105(10):1698-706. doi: 10.1111/j.1360-0443.2009.02890.x.
- Background: PubMed 23231989Calhoun VD, Adali T. Multisubject independent component analysis of fMRI: a decade of intrinsic networks, default mode, and neurodiagnostic discovery. IEEE Rev Biomed Eng. 2012;5:60-73. doi: 10.1109/RBME.2012.2211076.
- Background: PubMed 11559959Calhoun VD, Adali T, Pearlson GD, Pekar JJ. A method for making group inferences from functional MRI data using independent component analysis. Hum Brain Mapp. 2001 Nov;14(3):140-51. doi: 10.1002/hbm.1048.
- Individual participant dataSharing planned: No
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A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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.
Barbara McCrady, PhD principal investigator
The University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Mindfulness Based Relapse Prevention in people with Alcohol Use Disorder and Alcohol Abuse, run by University of New Mexico 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 7 inclusion and 10 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 22 Apr 2025. 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?
Percent heavy drinking days (time frame: Baseline, 4-week within treatment visit, 8-week within treatment visit, and 3-month follow-up, 9-month follow-up, and 15-month follow-up). 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 NCT03842670, which also lists 106 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 22 Apr 2025.