NCT02600832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
Last Updated

June 18, 2024

Status Verified

December 1, 2018

Enrollment Period

2.1 years

First QC Date

November 5, 2015

Last Update Submit

June 14, 2024

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Drinks per week (DPW)

    4 weeks

  • Heavy Drinking Days Per Week (HDD)

    4 weeks

Other Outcomes (1)

  • Executive Function

    4 weeks

Study Arms (2)

AABM Training

EXPERIMENTAL

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

Behavioral: AABM Training

Sham Training

SHAM COMPARATOR

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

Behavioral: Sham Training

Interventions

AABM TrainingBEHAVIORAL

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.

Also known as: AABM
AABM Training
Sham TrainingBEHAVIORAL

Sham training is identical to AABM training, except pictures are presented randomly in both formats.

Sham Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

January 1, 2016

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

June 18, 2024

Record last verified: 2018-12

Locations

US(1)