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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 fa
Sponsor: University of California, San Francisco

Current Primary Outcome: retainment [ Time Frame: 4 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Drinks per week (DPW) [ Time Frame: 4 weeks ]
    Number of standard alcohol drinks per week.
  • Heavy Drinking Days Per Week (HDD) [ Time Frame: 4 weeks ]
    Total number of heavy drinking days per week as defined by NIAAA criteria (>3 drinks/day for women; >4 drinks/day for men).


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: November 5, 2015
Date Started: January 2016
Date Completion: January 2018
Last Updated: December 2, 2016
Last Verified: December 2016