N/A
Completed N=182
Alcohol, Inflammation, and Mindfulness Study (AIM)
Source: ClinicalTrials.gov NCT02994043 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Heavy Drinking Days at Baseline — 12.6; 11.7 Heavy Drinking Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heavy Drinking Days at Baseline |
12.6; 11.7 | — |
| PRIMARY Heavy Drinking Days at Week 4 |
7.8; 7.6 | — |
| PRIMARY Heavy Drinking Days at Week 8 |
6.5; 5.3 | — |
| PRIMARY Heavy Drinking Days at Week 20 |
6.1; 7.3 | — |
| PRIMARY Heavy Drinking Days at Week 32 |
4.7; 7.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02994043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.