Clinical trial NCT03898323: Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)
Official title: Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: human laboratory
alcohol approach bias modification
alcohol use disorder
non-treatment seeking
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco VA Health Care System
First posted: 2019-04-01
Enrollment: 3
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 12 months
measure: Retention Feasibility
timeFrame: 6 weeks
measure: Tolerability Feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Alcohol Craving
timeFrame: 6 weeks
measure: Alcohol Consumption (Number of Standard Drinks Consumed)
timeFrame: 2 days (1 day each for ADP session 1 and 2)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Health Care System
state: California
Study officials:
affiliation: University of California, San Francisco/San Francisco VA Health Care System
name: Steven L. Batki, MD
role: PRINCIPAL_INVESTIGATOR
References: