N/A
N=3
Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03898323 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Recruitment Feasibility — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alcohol Approach Bias Modification (Device)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility |
3 | — |
| PRIMARY Retention Feasibility |
2 | — |
| PRIMARY Tolerability Feasibility |
1; 1; 2; 1; 1 | — |
| SECONDARY Alcohol Craving |
27.3; 23.3 | — |
| SECONDARY Alcohol Consumption (Number of Standard Drinks Consumed) |
1.5; 0.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men, ages 21-50;
- Able to read English and to complete study evaluations;
- 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.
- 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.
- At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening.
Exclusion Criteria
- Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- Current DSM-V non-alcohol use disorder other than tobacco and marijuana;
- Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates;
- 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;
- Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
- Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous;
- History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score > 8;
- Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods;
- Participants who have taken any investigational drug within 4 weeks preceding study entry.
Data sourced from ClinicalTrials.gov (NCT03898323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.