Clinical trial NCT05372029: AAT for Alcohol Use Disorder in Veterans
Official title: Enhancing Treatment Outcomes Among Veterans With Alcohol Use Disorder: Clinical and Neural Markers of Adjunctive Approach-avoidance Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: alcohol
cognitive training
intervention
neuroimaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial of AAT versus comparator
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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, 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.

Eligibility criteria: Inclusion Criteria:

* fluent in English
* primary diagnosis of AUD with no more than 90 days abstinence from alcohol
* 4-week stability if taking psychotropic medications

Exclusion Criteria:

* lifetime history of psychotic or bipolar disorder
* neurodegenerative or neurodevelopmental disorders
* history of moderate or severe traumatic brain injury or other known neurological condition
* sensory deficits that would preclude completing tasks
* suicidal or homicidal ideation within the past month necessitating urgent higher level care
* concurrent individual psychotherapy or other treatment outside of standard DDRP programming
* conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)

Primary outcomes:
measure: Change in the Drinker Inventory of Consequences (DrInC)
timeFrame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Secondary outcomes:
measure: Change in the Timeline Follow-back Procedure (TLFB)
timeFrame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
measure: Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score)
timeFrame: Baseline, post (week 6)
measure: Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal)
timeFrame: Baseline, post (week 6)
Other outcomes:
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
measure: Change in The Substance Use Recovery Evaluator (SURE)
timeFrame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
measure: Change in Alcohol Inhibition fMRI task (BOLD neural signal)
timeFrame: Baseline, post (week 6)
measure: Change in Alcohol Cue Reactivity fMRI task
timeFrame: Baseline, post (week 6)
measure: Stages of Change Readiness and Eagerness Scale (SOCRATES)
timeFrame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Jessica A Bomyea, PhD
role: PRINCIPAL_INVESTIGATOR
References: