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Behavioral Intervention

Approach Avoidance Training for Alcohol Use Disorder

N/A

Recruiting

Led By Jessica A Bomyea, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Concurrent individual psychotherapy or other treatment outside of standard DDRP programming

Neurodegenerative or neurodevelopmental disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

Summary

This trial will test a new treatment for alcohol use disorders to see if it helps reduce hazardous drinking and improve social, occupational, and domestic functioning.

Who is the study for?

This trial is for English-speaking Veterans with Alcohol Use Disorder (AUD) who have been sober for no more than 90 days and are stable on any psychotropic medications for at least 4 weeks. It's not suitable for those with a history of severe mental health disorders, neurological conditions, sensory deficits, recent suicidal or homicidal thoughts, or anyone receiving concurrent psychotherapy outside standard care.

What is being tested?

The study tests Approach Avoidance Training (AAT), a computer-based treatment aiming to alter the impulse to seek out alcohol-related cues. This is combined with standard VA care to see if it helps reduce drinking and improve social and occupational functioning in Veterans with AUD.

What are the potential side effects?

Since AAT involves psychological training rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort from confronting alcohol-related cues during the training.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving individual psychotherapy or treatments outside of standard programs.

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I have a condition that affects the development or function of my brain.

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I do not have sensory deficits that stop me from completing tasks.

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I have had a serious head injury or another neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post (week 6), follow up 1 (3 mo.), followup 2 (6 mo.) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Drinker Inventory of Consequences (DrInC)

Secondary study objectives

Change in Alcohol Approach Avoidance Behavioral Assessment (approach bias score)

Change in Alcohol Approach Avoidance Imaging Assessment (BOLD neural signal)

Change in the Timeline Follow-back Procedure (TLFB)

Other study objectives

Change in Alcohol Cue Reactivity fMRI task

Change in Alcohol Inhibition fMRI task (BOLD neural signal)

Change in Sheehan Disability Scale (SDS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Approach Avoidance TrainingExperimental Treatment1 Intervention

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

Group II: Sham TrainingPlacebo Group1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Approach Avoidance Training

2015

N/A

~60

0 / 4Eligibility criteria met