NCT02994043

Alcohol, Inflammation, and Mindfulness Study (AIM)

Completed NA Results posted Last updated 19 January 2023

What this trial tests

NA trial testing Mindfulness-Based Relapse Prevention Therapy in Alcohol Use Disorder in 182 participants. Completed in 17 February 2021.

Timeline

9 November 2016

Primary endpoint
17 February 2021

17 February 2021

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	182
Start date	9 November 2016
Primary completion	17 February 2021
Estimated completion	17 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Relapse Prevention Therapy
• Relapse Prevention Therapy

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

University of Colorado, Denver

Who can join

Adults 21 to 60, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Heavy Drinking Days at Baseline Primary · Baseline

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Group	Value	95% CI
Mindfulness-Based Relapse Prevention	12.6	± 10.3
Relapse Prevention	11.7	± 10.5

Heavy Drinking Days at Week 4 Primary · Week 4

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Group	Value	95% CI
Mindfulness-Based Relapse Prevention	7.8	± 8.2
Relapse Prevention	7.6	± 8.5

Heavy Drinking Days at Week 8 Primary · Week 8

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Group	Value	95% CI
Mindfulness-Based Relapse Prevention	6.5	± 7.9
Relapse Prevention	5.3	± 7.6

Heavy Drinking Days at Week 20 Primary · Week 20

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Group	Value	95% CI
Mindfulness-Based Relapse Prevention	6.1	± 8.0
Relapse Prevention	7.3	± 8.8

Heavy Drinking Days at Week 32 Primary · Week 32

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Group	Value	95% CI
Mindfulness-Based Relapse Prevention	4.7	± 6.5
Relapse Prevention	7.7	± 8.2

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune treatments for alcohol use disorder: A translational framework.
   Meredith LR, Burnette EM, Grodin EN, Irwin MR, et al · · 2021 · cited 50× · PMID 34343618 · DOI 10.1016/j.bbi.2021.07.023
2. Effects of cannabis use on alcohol consumption in a sample of treatment-engaged heavy drinkers in Colorado.
   Karoly HC, Ross JM, Prince MA, Zabelski AE, et al · · 2021 · cited 20× · PMID 33464670 · DOI 10.1111/add.15407
3. Exploring relationships between alcohol consumption, inflammation, and brain structure in a heavy drinking sample.
   Karoly HC, Skrzynski CJ, Moe EN, Bryan AD, et al · · 2021 · cited 16× · PMID 34523725 · DOI 10.1111/acer.14712
4. Mindfulness mechanisms in alcohol use: Comparing top-down and bottom-up processes.
   Skrzynski CJ, Bryan AD, Hutchison KE. · · 2024 · cited 1× · PMID 37199963 · DOI 10.1037/adb0000932