Alcohol Use Disorder Clinical Trial
— ADP + AABMOfficial title:
Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study
Verified date | July 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco VA Health Care System | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | San Francisco VA Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Tolerability feasibility | Tolerability feasibility as measured by the number and frequency of adverse events. | 18 months | |
Secondary | Alcohol craving | Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS). | 2 weeks | |
Secondary | 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 |
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