An interventional study of Approach Avoidance Training and Sham Training in Alcohol Use Disorder, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover from alcohol-related functional impairments across social, occupational, and domestic domains. To do so, the investigators will evaluate clinical, cognitive, and neural effects of a computer-delivered Approach Avoidance Training (AAT) treatment - which changes implicit tendencies to approach alcohol-related cues - in conjunction with standard VA care. The project will support RR\&D's mission to improve Veterans' participation in their lives and community by determining if this innovative alternative technique can improve recovery outcomes for Veterans with AUD and exploring how the intervention works.
Veterans with alcohol use disorders (AUD) would be greatly served by development of effective interventions to address high relapse rates and difficulty with resuming optimal functional recovery (i.e., re-engaging in vocational, social, and daily life roles that are critical to maintaining alcohol consumption goals). Approach bias toward alcohol, an implicit motivational response to alcohol cues observable across behavioral and neural indicators, is a core feature of AUD that impedes recovery but is not routinely treated in standard care. Treatment options that target approach bias may improve outcomes by decreasing the appetitive pull of alcohol, so that individuals are better able to disengage from habitual drinking behaviors in the service of their functional goals and objectives. Approach Avoidance Training (AAT) is a computer-delivered treatment program that shifts behavioral and neural indicators of approach bias for alcohol and has been shown to improve drinking-related outcomes in AUD when used in conjunction with standard care. Given the promise of this intervention for AUD, there is a critical need to determine if this treatment can be successfully used for Veterans who commonly present with complex comorbidities, and to pinpoint cognitive and neurobiological processes of change. The overall objectives of this proposal are to determine whether Alcohol Approach Avoidance Training (AAT) improves recovery outcomes in Veterans undergoing standard care for AUD with co-occurring conditions, and to identify the underlying cognitive and neural substrates modified. The central hypothesis is that AAT training will improve critical recovery outcomes for Veterans and improve behavioral and neural indicators of approach bias. The investigators will explore whether effects of AAT generalize to related top-down and bottom-up neurocognitive processes. The investigators will also explore potential predictors of treatment response. The overall objectives will be addressed in a randomized controlled trial of 136 Veterans completing standard care in the local VA setting with either AAT or a control condition. Aim 1 will determine if repeatedly practicing avoidance of alcohol cues through AAT can improve recovery outcomes and hazardous drinking. Aim 2 will determine if AAT modifies approach bias by measuring this construct with multiple assessment methods (i.e., behavioral, Functional magnetic resonance imaging (fMRI)). Exploratory aims will examine if AAT modifies inhibition (top-down) and cue reactivity (bottom up) processing, and the extent to which baseline comorbidity severity, treatment engagement characteristics, or baseline approach bias (behavioral task reaction times, brain response during fMRI) are associated with clinical outcomes. The project is expected to determine if AAT shows clinical potential that would warrant expansion to other substances of abuse and a larger multisite confirmatory efficacy trial in Veterans with AUD. Results of the study will inform the utility of AAT as an adjunctive AUD treatment for Veterans, potentially offering a novel, low-cost, and portable alternative option to improve recovery in these individuals. Consistent with the RR\&D mission to maximize "functional independence, quality of life and participation in their lives and community," the project will provide a foundation for neuroscience-based alternative therapeutic options to improve recovery in Veterans with AUD.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 176 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors
Behavioral: Approach Avoidance Training
In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)
Behavioral: Sham Training
AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors
Also known as: AAT
In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)
Change in the Drinker Inventory of Consequences (DrInC)
The DrInC assesses alcohol-related adverse functional consequences across physical (e.g., harmed physical health), interpersonal (e.g., loss of relationships), role responsibilities (e.g., missed work), psychological (e.g., loss of hobbies), and impulse control-related problems (e.g., legal problems) with higher scores indicating worse outcomes. Total scores range from 0 to 50.
Time frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Change in the Timeline Follow-back Procedure (TLFB)
The TLFB evaluates drinking and all drug use during the 90 days preceding interviews. Percent heavy drinking days ranges from 0-100% with higher indicating more days.
Time frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score)
Participants must pull or push alcohol or neutral cues using a joystick. The outcome approach bias score is computed by subtracting each participant's mean response latency in the pull condition from his or her mean response latency in the corresponding push condition (e.g., alcohol-push minus alcohol-pull). Higher scores indicate higher approach bias.
Time frame: Baseline, post (week 6)
Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal)
Participants must pull or push alcohol or neutral cues using a joystick while undergoing functional MRI. The outcome is BOLD percent signal change to a contrast comparing alcohol to neutral beverage for push versus pull. Higher scores indicate higher percent signal change.
Time frame: Baseline, post (week 6)
Change in Sheehan Disability Scale (SDS)
The SDS assesses functional impairment due to clinical symptoms across three domains: work/school, social functioning, and family life. Higher scores indicate higher functional impairment. Domain scores range from 0-10.
Time frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Change in The Substance Use Recovery Evaluator (SURE)
The SURE measures alcohol recovery along the following domains: substance use, material resources, self-care, relationships, and outlook on life. Higher scores indicate worse recovery outcomes. Total scores range from 21-63.
Time frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Change in Alcohol Inhibition functional Magnetic Resonance Imaging (fMRI) task (BOLD neural signal)
Participants are shown an alcohol or neutral cue and must decide to respond or not respond as quickly as possible. The outcome is BOLD percent signal change to a contrast comparing inhibition versus non-inhibition trials. Higher scores indicate higher percent signal change.
Time frame: Baseline, post (week 6)
Change in Alcohol Cue Reactivity functional Magnetic Resonance Imaging (fMRI) task
Participants passively view alcohol or neutral cues. The outcome is BOLD percent signal change to a contrast comparing alcohol cues to non-alcohol cue trials. Higher scores indicate higher percent signal change.
Time frame: Baseline, post (week 6)
Stages of Change Readiness and Eagerness Scale (SOCRATES)
The SOCRATES measures readiness to change drinking related behavior with higher scores indicating greater readiness to change.
Time frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Plan to share: No
Started Feb 2023 (actual). Primary completion is estimated for Jan 2027, 46 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 46 months is above that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Jan 2027, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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