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

Not Applicable

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Device: Alcohol Approach Bias Modification

• Registration Number: NCT03898323
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

The investigators hoped to recruit 12 participants to enroll and start the clinical trial over the course of 1 year.

Study Timeline

• Study First Submitted: 2019-01-02
• Study Start: 2019-02-01
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Disposition First Submitted: 2020-12-22
• Results First Submitted: 2022-06-06
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-24
• Last Update Submitted: 2024-05-24
• Results First Posted: 2024-06-18
• Disposition First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

1. Men, ages 21-50;
2. Able to read English and to complete study evaluations;
3. 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.
4. 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.
5. At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening.

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Exclusion Criteria

1. Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
2. Current DSM-V non-alcohol use disorder other than tobacco and marijuana;
3. Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates;
4. 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;
5. Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
6. Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous;
7. History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score > 8;
8. Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods;
9. Participants who have taken any investigational drug within 4 weeks preceding study entry.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AABM Training	Alcohol Approach Bias Modification	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.

Primary Outcome Measures

Name	Time	Method
Tolerability Feasibility	6 weeks	Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
Retention Feasibility	6 weeks	Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.
Recruitment Feasibility	12 months	The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.

Secondary Outcome Measures

Name	Time	Method
Alcohol Craving	6 weeks	Alcohol craving will be measured during ADP sessions 1 and 2 using the Alcohol Urge Questionnaire (AUQ).; Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1 and 2, using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before alcohol administration and at various times after alcohol administration. The AUQ score reported here is the highest AUQ score obtained for that ADP session.
Alcohol Consumption (Number of Standard Drinks Consumed)	2 days (1 day each for ADP session 1 and 2)	Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during ADP session 1 (before 2 weeks of AABM training) and ADP session 2 (after the 2 weeks of AABM training). Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.

Trial Locations

Locations (1)

San Francisco VA Health Care System; 🇺🇸 San Francisco, California, United States