Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for AUD (ADP + AABM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898323
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
San Francisco VA Health Care System
Information provided by (Responsible Party):
Steven Batki, University of California, San Francisco

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 3 weeks of AABM or sham training.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: Alcohol Approach Bias Modification (active) Device: Alcohol Approach Bias Modification (sham) Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Active vs. sham training
Primary Purpose: Treatment
Official Title: ALCOHOL APPROACH BIAS MODIFICATION EFFECTS ON ALCOHOL CONSUMPTION: A PILOT HUMAN LABORATORY STUDY
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: AABM Training
Alcohol Approach Bias Modification (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. AABM training consists of 3 sessions per week over 3 weeks, for a total of 9 sessions.
Device: Alcohol Approach Bias Modification (active)
Computerized training - Active intervention

Sham Comparator: Sham AABM Training
Sham training is identical to AABM training, except pictures are presented randomly in both formats.
Device: Alcohol Approach Bias Modification (sham)
Computerized training - Sham intervention




Primary Outcome Measures :
  1. Recruitment feasibility [ Time Frame: 18 months ]
    Feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 12 participants.

  2. Retention feasibility [ Time Frame: 18 months ]
    Retention feasibility as measured by the proportion of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 3-week course of 9 AABM/sham training sessions.

  3. Tolerability feasibility [ Time Frame: 18 months ]
    Tolerability feasibility as measured by differences in the number and frequency of adverse events reported for participants in the 2 treatment conditions


Secondary Outcome Measures :
  1. Alcohol craving [ Time Frame: 3 weeks ]
    Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS).

  2. Alcohol consumption [ Time Frame: 3 weeks ]
    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 3 weeks of AABM/sham training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898323


Contacts
Layout table for location contacts
Contact: Steven L. Batki, MD 415-221-4810 ext 23671 steven.batki@ucsf.edu
Contact: Brooke A. Lasher, BA 415-221-4810 ext 24495 brooke.lasher@va.gov

Locations
Layout table for location information
United States, California
San Francisco VA Health Care System Recruiting
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
San Francisco VA Health Care System
Investigators
Layout table for investigator information
Principal Investigator: Steven L. Batki, MD University of California, San Francisco/San Francisco VA Health Care System

Layout table for additonal information
Responsible Party: Steven Batki, Professor of Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03898323     History of Changes
Other Study ID Numbers: UCSF REAC RAP
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is a pilot feasibility study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steven Batki, University of California, San Francisco:
human laboratory
alcohol approach bias modification
alcohol use disorder
non-treatment seeking
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs