Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)

Study Overview
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Brief Summary
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The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We will measure feasibility with respect to recruitment, retention and tolerability of AABM training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of AABM training.

Detailed Description
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Twelve heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will receive 2 weeks of AABM training preceded and followed by a 1-day ADP session. AABM training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Training is conducted in 3 sessions per week for 2 weeks, for a total of 6 sessions. The ADP session is a one day human laboratory session taking place at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study intervention (AABM training) on alcohol craving and alcohol consumption.

Official Title
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Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: Alcohol Approach Bias Modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, ages 21-50; Able to read English and to complete study evaluations; Risky (also known as high-risk, or hazardous, or heavy) alcohol use, defined as 25-70 standard drinks per week on average over the past 30 days; Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on average over the past 30 days. No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions. At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening. Exclusion Criteria: Individuals who are seeking AUD treatment or have been in treatment within the past 6 months; Current DSM-V non-alcohol use disorder other than tobacco and marijuana; Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates; Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation; Psychosis or any other serious mental illness as judged by SCID and study physician assessment; Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous; History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score > 8; Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods; Participants who have taken any investigational drug within 4 weeks preceding study entry.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AABM Training<br>Alcohol Approach Bias Modification (AABM) training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. AABM training consists of 3 sessions per week over 2 weeks, for a total of 6 sessions. | Device: Alcohol Approach Bias Modification<br>* Computerized training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment feasibility | Feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 12 participants. | 18 months | 
| Retention feasibility | Retention feasibility as measured by the proportion of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions. | 18 months | 
| Tolerability feasibility | Tolerability feasibility as measured by the number and frequency of adverse events. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol craving | Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS). | 2 weeks | 
| Alcohol consumption | Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during the ADP sessions before and after the 2 weeks of AABM training. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol use disorder, human laboratory, alcohol approach bias modification, non-treatment seeking