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

Alcohol Use Disorder Clinical Trial

— ADP + AABM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898323
• Other study ID #: UCSF REAC RAP
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Device:
• Alcohol Approach Bias Modification
Computerized training

Locations

Country	Name	City	State
United States	San Francisco VA Health Care System	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility	The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.	12 months
Primary	Retention Feasibility	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.	6 weeks
Primary	Tolerability Feasibility	Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.	6 weeks
Secondary	Alcohol Craving	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.	6 weeks
Secondary	Alcohol Consumption (Number of Standard Drinks Consumed)	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.	2 days (1 day each for ADP session 1 and 2)