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

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AABM Training
Sham Training
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical Center San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AABM Training

Sham Training

Arm Description

Immediately following screening, patients will be randomly assigned to receive 9 sessions of real AABM training (16 subjects each) taking place over three weeks.

Immediately following screening, patients will be randomly assigned to receive 9 sessions of sham training (16 subjects each) taking place over three weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Drinks per week (DPW)
Number of standard alcohol drinks per week.
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).

Full Information

First Posted
November 5, 2015
Last Updated
December 18, 2018
Sponsor
University of California, San Francisco
Collaborators
Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02600832
Brief Title
AABM to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study
Acronym
AABM
Official Title
Alcohol Approach Bias Modification to Decrease Problem Drinking and Impulsivity in Veterans With AUD: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AABM Training
Arm Type
Experimental
Arm Description
Immediately following screening, patients will be randomly assigned to receive 9 sessions of real AABM training (16 subjects each) taking place over three weeks.
Arm Title
Sham Training
Arm Type
Sham Comparator
Arm Description
Immediately following screening, patients will be randomly assigned to receive 9 sessions of sham training (16 subjects each) taking place over three weeks.
Intervention Type
Behavioral
Intervention Name(s)
AABM Training
Other Intervention Name(s)
AABM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham Training
Intervention Description
Sham training is identical to AABM training, except pictures are presented randomly in both formats.
Primary Outcome Measure Information:
Title
retainment
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Drinks per week (DPW)
Description
Number of standard alcohol drinks per week.
Time Frame
4 weeks
Title
Heavy Drinking Days Per Week (HDD)
Description
Total number of heavy drinking days per week as defined by NIAAA criteria (>3 drinks/day for women; >4 drinks/day for men).
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Executive Function
Description
z-score of executive function domains.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female veterans eligible for VA services. Ages 18-65 Must meet criteria for current (not in remission) AUD using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 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. Must express a desire to reduce, stop or abstain from alcohol use. Must be enrolled in AUD treatment at the San Francisco Veterans Affairs Health Care System. Exclusion Criteria: Psychotic disorders, bipolar disorder, dementia, or other psychiatric or medical condition judged to be unstable. Concurrent participation in another AUD treatment study. Needing acute medical detoxification from alcohol based on a score ≥ 12 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD). Subjects legally mandated to participate in an alcohol treatment program.
Facility Information:
Facility Name
VA Medical Center San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

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

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