Alcohol, Inflammation, and Mindfulness Study (AIM)
Dismantling MBRP: Identifying Critical Neuroimmune Mechanisms of Action.
2 other identifiers
interventional
182
1 country
1
Brief Summary
The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders (AUD) by implementing an 8-week long intervention and examining neurobiological, immunological, and epigenetic characteristics of AUD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2016
CompletedFirst Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2021
CompletedResults Posted
Study results publicly available
January 19, 2023
CompletedJanuary 19, 2023
December 1, 2022
4.3 years
December 12, 2016
July 19, 2022
December 22, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Heavy Drinking Days at Baseline
Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
Baseline
Heavy Drinking Days at Week 4
Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
Week 4
Heavy Drinking Days at Week 8
Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
Week 8
Heavy Drinking Days at Week 20
Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
Week 20
Heavy Drinking Days at Week 32
Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)
Week 32
Study Arms (2)
MBRP
ACTIVE COMPARATORRP
ACTIVE COMPARATORInterventions
An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.
Eligibility Criteria
You may qualify if:
- Have a primary Diagnostic Statistical Manual-V (DSM-V) diagnosis of alcohol use disorder;
- Must be within 10 days of last drink;
- Must have been drinking heavily (criteria dependent upon individual?s age, gender, and BMI) for a consistent period of time;
- Must have a breath alcohol level of 0 at screening;
- Must have a Clinical Institute Withdrawal Assessment (CIWA) score less than 8 (indicating no need for medical detox);
- Must have expressed a desire during their initial screen to reduce the number of drinks they regularly consume
You may not qualify if:
- Currently taking any medications for the treatment of psychiatric disorders, including substance use disorders, mood disorders, and psychosis;
- Pregnant, as indicated by a pregnancy test which will be administered at baseline;
- Positive for, sedatives, opiates, cocaine, or amphetamine on drug screen at baseline;
- Meets criteria for psychotic disorder, bipolar disorder, or a major depressive episode
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver
Denver, Colorado, 80045, United States
Related Publications (3)
Skrzynski CJ, Karoly H, Ellingson JM, Hagerty SL, Bryan AD, Hutchison KE. Comparing the Efficacy of Mindfulness-Based Relapse Prevention Versus Relapse Prevention for Alcohol Use Disorder: A Randomized Control Trial. J Stud Alcohol Drugs. 2023 Jul;84(4):560-569. doi: 10.15288/jsad.21-00392. Epub 2023 Feb 1.
PMID: 36971735DERIVEDKaroly HC, Skrzynski CJ, Moe EN, Bryan AD, Hutchison KE. Exploring relationships between alcohol consumption, inflammation, and brain structure in a heavy drinking sample. Alcohol Clin Exp Res. 2021 Nov;45(11):2256-2270. doi: 10.1111/acer.14712. Epub 2021 Sep 22.
PMID: 34523725DERIVEDKaroly HC, Ross JM, Prince MA, Zabelski AE, Hutchison KE. Effects of cannabis use on alcohol consumption in a sample of treatment-engaged heavy drinkers in Colorado. Addiction. 2021 Sep;116(9):2529-2537. doi: 10.1111/add.15407. Epub 2021 Jan 26.
PMID: 33464670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jamie Laurin
- Organization
- University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Hutchison
University of Colorado Denver | Anschutz
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
December 15, 2016
Study Start
November 9, 2016
Primary Completion
February 17, 2021
Study Completion
February 17, 2021
Last Updated
January 19, 2023
Results First Posted
January 19, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share