AAT for Alcohol Use Disorder in Veterans

• ClinicalTrials.gov Identifier: NCT05372029
• Recruitment Status: Not yet recruiting
• First Posted: May 12, 2022
• Last Update Posted: December 20, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: May 9, 2022
• First Posted Date: May 12, 2022
• Last Update Posted Date: December 20, 2022
• Estimated Study Start Date: April 3, 2023
• Estimated Primary Completion Date: October 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 9, 2022)

Change in the Drinker Inventory of Consequences (DrInC) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 9, 2022)

• Change in the Timeline Follow-back Procedure (TLFB) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  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.
• Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score) [ Time Frame: Baseline, post (week 6) ]
  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.
• Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal) [ Time Frame: Baseline, post (week 6) ]
  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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 15, 2022)

• Change in Sheehan Disability Scale (SDS) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  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.
• Change in The Substance Use Recovery Evaluator (SURE) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  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.
• Change in Alcohol Inhibition fMRI task (BOLD neural signal) [ Time Frame: Baseline, post (week 6) ]
  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.
• Change in Alcohol Cue Reactivity fMRI task [ Time Frame: Baseline, post (week 6) ]
  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.
• Stages of Change Readiness and Eagerness Scale (SOCRATES) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  The SOCRATES measures readiness to change drinking related behavior with higher scores indicating greater readiness to change.

Original Other Pre-specified Outcome Measures (submitted: May 9, 2022)

• Change in Sheehan Disability Scale (SDS) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  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.
• Change in The Substance Use Recovery Evaluator (SURE) [ Time Frame: Baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) ]
  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.
• Change in Alcohol Go/no-go (GNG) fMRI task (BOLD neural signal) [ Time Frame: Baseline, post (week 6) ]
  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 "go" to "nogo" trials. Higher scores indicate higher percent signal change.
• Change in Alcohol Cue Reactivity fMRI task [ Time Frame: Baseline, post (week 6) ]
  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.

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two group randomized controlled trial of AAT versus comparator

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Randomization will occur using a code corresponding to intervention arm. Participant and provider will not know the number-condition link.

Primary Purpose: Treatment

• Condition: Alcohol Use Disorder

Intervention

• Behavioral: Approach Avoidance 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
  Other Name: AAT
• Behavioral: Sham 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)

Study Arms

• Experimental: Approach Avoidance 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
  Intervention: Behavioral: Approach Avoidance Training
• Sham Comparator: Sham 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)
  Intervention: Behavioral: Sham Training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 9, 2022): 176
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 3, 2026
• Estimated Primary Completion Date: October 31, 2025 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jessica A Bomyea, PhD; (858) 642-3720; jessica.bomyea@va.gov

Contact: Andrea Spadoni Townsend, PhD; (858) 855-8585; aspadoni@health.ucsd.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05372029
• Other Study ID Numbers: D3793-R
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jessica A Bomyea, PhD; VA San Diego Healthcare System, San Diego, CA

• PRS Account: VA Office of Research and Development
• Verification Date: December 2022