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

NCT ID: NCT03898323

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-01-31

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AABM Training

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.

Group Type: EXPERIMENTAL

Alcohol Approach Bias Modification

Intervention Type: DEVICE

Computerized training

Interventions

Alcohol Approach Bias Modification

Computerized training

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco VA Health Care System

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven L. Batki, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco/San Francisco VA Health Care System

Locations

San Francisco VA Health Care System

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UCSF REAC RAP

Identifier Type: -

Identifier Source: org_study_id