- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842670
Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder (ABQTREAT)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barbara McCrady, PhD
- Phone Number: 505-925-2833
- Email: bmccrady@unm.edu
Study Contact Backup
- Name: Eric Claus, PhD
- Email: eclaus@mrn.org
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- The University of New Mexico
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Albuquerque, New Mexico, United States, 87106
- The Mind Research Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Cognitive-Behavior Therapy
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.
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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.
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Active Comparator: Mindfulness Based Relapse Prevention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MOBC: Craving - self report
Time Frame: Up to 15 months
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Penn Alcohol Craving Scale will be used to examine changes in craving that occur during and after treatment.
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Up to 15 months
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MOBC: Craving - neuroimaging
Time Frame: Up to 9 months
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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
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Up to 9 months
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MOBC: Cognitive and Behavioral Control - self report impulsivity
Time Frame: Up to 15 months
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The UPPS-P Impulsivity Questionnaire will be used to examine changes in impulsivity that occur during and after treatment.
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Up to 15 months
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MOBC: Cognitive and Behavioral Control - behavior
Time Frame: Up to 15 months
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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.
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Up to 15 months
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MOBC: Cognitive and Behavioral Control - neuroimaging inhibition
Time Frame: Up to 9 months
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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.
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Up to 9 months
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MOBC: Cognitive and Behavioral Control - neuroimaging errors
Time Frame: Up to 9 months
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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.
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Up to 9 months
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MOBC: Regulation of Affect/Arousal - neuroimaging
Time Frame: Up to 9 months
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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.
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Up to 9 months
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MOBC: Regulation of Affect/Arousal - negative affect self-report
Time Frame: Up to 15 months
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The Negative Affect Summary score from the NIH toolbox will be used to assess overall negative affect changes during and after treatment.
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Up to 15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The Form 90 will be used to derive estimates of the outcome percent drinking days.
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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
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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
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The Form 90 will be used to derive estimates of the outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.
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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
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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
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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.
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara McCrady, PhD, The University of New Mexico
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1240557-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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