Summary

for males ages 21-50 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Steven L. Batki, MD

Description

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 3 weeks of AABM or sham training.

Official Title

ALCOHOL APPROACH BIAS MODIFICATION EFFECTS ON ALCOHOL CONSUMPTION: A PILOT HUMAN LABORATORY STUDY

Details

Twelve heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will be randomly assigned to 3 weeks of AABM or sham 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. Sham training is identical to AABM training except for the random nature of image formats presented. Training is conducted in 3 sessions per week for 3 weeks, for a total of 9 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 or sham training) on alcohol craving and alcohol consumption.

Keywords

Alcohol Use Disorder human laboratory alcohol approach bias modification non-treatment seeking Alcohol Drinking Alcoholism Ethanol Alcohol Approach Bias Modification (active) AABM Training

Eligibility

You can join if…

Open to males ages 21-50

  • Men, ages 21-50;
  • Able to read English and to complete study evaluations;
  • Meet DSM-V criteria for current alcohol use disorder (AUD);
  • Average weekly alcohol use of 25-70 standard drinks for men 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.

You CAN'T join if...

  • 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 cannabis;
  • 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;
  • Any other medical conditions that in the opinion of the study physician would make study participation hazardous;
  • History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Withdrawal Assessment Scale (CIWA-AD) score greater than or equal to 8;
  • Participants who report disliking spirits will be excluded because 80 proof liquor will be provided during the alcohol self-administration periods;
  • Participants who have taken any investigational drug within 4 weeks preceding study entry.

Location

  • San Francisco VA Health Care System accepting new patients
    San Francisco California 94121 United States

Lead Scientist

  • Steven L. Batki, MD
    Steven L. Batki, M.D. is Professor of Psychiatry, in Residence, at the University of California, San Francisco (UCSF) School of Medicine and Chief of the Substance Abuse Programs and Director of the Addiction Psychiatry Research Program at the San Francisco VA Medical Center (SFVAMC), where he also directs the UCSF Addiction Psychiatry Fellowship Program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03898323
Study Type
Interventional
Last Updated