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AAT for Alcohol Use Disorder in Veterans

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Approach Avoidance Training
Sham Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol, cognitive training, intervention, neuroimaging

Eligibility Criteria

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

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)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Approach Avoidance Training

Sham Training

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 9, 2022
Last Updated
February 15, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05372029
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
April 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
alcohol, cognitive training, intervention, neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled trial of AAT versus comparator
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization will occur using a code corresponding to intervention arm. Participant and provider will not know the number-condition link.
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Approach Avoidance Training
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Training
Arm Type
Sham Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Approach Avoidance Training
Other Intervention Name(s)
AAT
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Sham Training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in the Drinker Inventory of Consequences (DrInC)
Description
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.)
Secondary Outcome Measure Information:
Title
Change in the Timeline Follow-back Procedure (TLFB)
Description
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.)
Title
Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score)
Description
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)
Title
Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal)
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in Sheehan Disability Scale (SDS)
Description
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.)
Title
Change in The Substance Use Recovery Evaluator (SURE)
Description
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.)
Title
Change in Alcohol Inhibition fMRI task (BOLD neural signal)
Description
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)
Title
Change in Alcohol Cue Reactivity fMRI task
Description
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)
Title
Stages of Change Readiness and Eagerness Scale (SOCRATES)
Description
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.)

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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica A Bomyea, PhD
Phone
(858) 642-3720
Email
jessica.bomyea@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Spadoni Townsend, PhD
Phone
(858) 855-8585
Email
aspadoni@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica A Bomyea, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia A Franklin, AA BS
Phone
858-552-8585
Ext
7441
Email
patricia.franklin2@va.gov
First Name & Middle Initial & Last Name & Degree
Jessica A Bomyea, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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AAT for Alcohol Use Disorder in Veterans

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