AABM to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study

Alcohol Use Disorder Clinical Trial

— AABM  

Official title:

Alcohol Approach Bias Modification to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600832
• Other study ID #: 24034
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 7, 2018

Study information

• Verified date: December 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the VA Medical Center at San Francisco, California, between ages 18-65. The study consists of screening, 3-week AABM training, Week-4 post-test, and Week-12 follow-up. Assessment of inhibitory control, alcohol approach bias and craving will be administered at baseline and Week-4. Immediately following screening, patients will be randomly assigned to receive 9 sessions of real or sham AABM training (16 subjects each) taking place over three weeks. Following the 3 weeks of training, patients will complete a Week-4 post-test which includes assessment of alcohol approach bias, inhibitory control, and craving and a Week-12 follow-up assessing drinking behavior.

Description:

The overall goal of the proposed project is to improve the treatment of veterans who consume alcohol at hazardous or harmful levels. We will conduct a pilot controlled clinical trial to assess the feasibility and acceptability of implementing an Alcohol Approach Bias Modification (AABM) task in veterans seeking outpatient treatment for alcohol use disorder (AUD). The investigators will also explore the efficacy of AABM to reduce alcohol use and enhance executive function. The proposed study is designed to test AABM as a novel, acceptable, safe, low-cost intervention to augment and boost the efficacy of standard outpatient treatment for reducing alcohol use and simultaneously improving executive function in veterans with AUD.

The proposed project will pursue three primary aims in veterans with an AUD who are drinking alcohol at hazardous or harmful levels: 1) Establish the feasibility of enrolling and retaining veterans with AUD for a 3-week randomized trial of AABM; 2) Obtain preliminary assessment of the efficacy of AABM treatment to decrease alcohol approach bias and alcohol use; 3) Obtain preliminary assessment of the efficacy of AABM treatment to improve neurocognitive functioning domains that typically show deficits in AUD populations. To achieve these aims, we will conduct pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 9-session (over 3 weeks) clinical trial of AABM in 32 male and female veterans entering treatment for AUD at the San Francisco VA Medical Center. We expect that this study will provide empirical data for recruitment, attrition and effect size estimation for a future randomized trial to definitively test that AABM reduces alcohol use and improves executive function in veterans with AUD. Moreover, findings from the proposed project are expected to improve the care of veterans with AUD, and by extension, to aid families and communities affected by the sequelae of these problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male and female veterans eligible for VA services.

2. Ages 18-65

3. Must meet criteria for current (not in remission) AUD using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

4. Must report "at-risk" or "heavy" drinking by NIH/NIAAA (National Institute on Health/National Institute on Alcohol Abuse and Alcoholism) criteria (>3 drinks/day or >7/week for women; >4 drinks/day or >14/week for men) for at least one week in the last 90 days.

5. Must express a desire to reduce, stop or abstain from alcohol use.

6. Must be enrolled in AUD treatment at the San Francisco Veterans Affairs Health Care System.

Exclusion Criteria:

1. Psychotic disorders, bipolar disorder, dementia, or other psychiatric or medical condition judged to be unstable.

2. Concurrent participation in another AUD treatment study.

3. Needing acute medical detoxification from alcohol based on a score = 12 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).

4. Subjects legally mandated to participate in an alcohol treatment program.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Impulsive Behavior

Intervention

Behavioral:
• AABM Training
The investigators will use a training version of the Alcohol Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Two hundred training trials are presented per session.
• Sham Training
Sham training is identical to AABM training, except pictures are presented randomly in both formats.

Locations

Country	Name	City	State
United States	VA Medical Center San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive Function	z-score of executive function domains.	4 weeks
Primary	retainment	Number of participants completing the 9 sessions of AABM or sham training divided by the total number of participants randomized to start AABM or sham training.	4 weeks
Secondary	Drinks per week (DPW)	Number of standard alcohol drinks per week.	4 weeks
Secondary	Heavy Drinking Days Per Week (HDD)	Total number of heavy drinking days per week as defined by NIAAA criteria (>3 drinks/day for women; >4 drinks/day for men).	4 weeks