Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for AUD (ADP + AABM)
|ClinicalTrials.gov Identifier: NCT03898323|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Device: Alcohol Approach Bias Modification (active) Device: Alcohol Approach Bias Modification (sham)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Active vs. sham training|
|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|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898323
|Contact: Steven L. Batki, MD||415-221-4810 ext firstname.lastname@example.org|
|Contact: Brooke A. Lasher, BA||415-221-4810 ext email@example.com|
|United States, California|
|San Francisco VA Health Care System||Recruiting|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Steven L. Batki, MD||University of California, San Francisco/San Francisco VA Health Care System|