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

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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

Tracking Information
First Submitted Date  ICMJE January 2, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03898323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Alcohol craving [ Time Frame: 3 weeks ]
    Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for AUD
Official Title  ICMJE ALCOHOL APPROACH BIAS MODIFICATION EFFECTS ON ALCOHOL CONSUMPTION: A PILOT HUMAN LABORATORY STUDY
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Active vs. sham training
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Device: Alcohol Approach Bias Modification (active)
    Computerized training - Active intervention
  • Device: Alcohol Approach Bias Modification (sham)
    Computerized training - Sham intervention
Study Arms  ICMJE
  • 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.
    Intervention: Device: Alcohol Approach Bias Modification (active)
  • Sham Comparator: Sham AABM Training
    Sham training is identical to AABM training, except pictures are presented randomly in both formats.
    Intervention: Device: Alcohol Approach Bias Modification (sham)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898323
Other Study ID Numbers  ICMJE UCSF REAC RAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: This is a pilot feasibility study.
Responsible Party Steven Batki, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE San Francisco VA Health Care System
Investigators  ICMJE
Principal Investigator: Steven L. Batki, MD University of California, San Francisco/San Francisco VA Health Care System
PRS Account University of California, San Francisco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP