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

Primary Purpose

Alcohol Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcohol Approach Bias Modification

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring human laboratory, alcohol approach bias modification, alcohol use disorder, non-treatment seeking

Eligibility Criteria

21 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

San Francisco VA Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AABM Training

Arm Description

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 2 weeks, for a total of 6 sessions.

Outcomes

Primary Outcome Measures

Recruitment feasibility

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

Retention feasibility as measured by the proportion of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.

Tolerability feasibility

Tolerability feasibility as measured by the number and frequency of adverse events.

Secondary Outcome Measures

Alcohol craving

Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS).

Alcohol consumption

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 2 weeks of AABM training.

Full Information

NCT ID

NCT03898323

First Posted

January 2, 2019

Last Updated

July 29, 2021

Sponsor

University of California, San Francisco

Collaborators

San Francisco VA Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT03898323

Brief Title

Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)

Acronym

ADP + AABM

Official Title

Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

January 31, 2020 (Actual)

Study Completion Date

January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

San Francisco VA Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 2 weeks of AABM training.

Detailed Description

Twelve heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will receive 2 weeks of AABM 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. Training is conducted in 3 sessions per week for 2 weeks, for a total of 6 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 training) on alcohol craving and alcohol consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

human laboratory, alcohol approach bias modification, alcohol use disorder, non-treatment seeking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AABM Training

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Alcohol Approach Bias Modification

Intervention Description

Computerized training

Primary Outcome Measure Information:

Title

Recruitment feasibility

Description

Feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 12 participants.

Time Frame

18 months

Title

Retention feasibility

Description

Retention feasibility as measured by the proportion of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.

Time Frame

18 months

Title

Tolerability feasibility

Description

Tolerability feasibility as measured by the number and frequency of adverse events.

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Alcohol craving

Description

Alcohol craving will be measured during ADP sessions 1 and 2 using the Obsessive Compulsive Drinking Scale (OCDS).

Time Frame

2 weeks

Title

Alcohol consumption

Description

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 2 weeks of AABM training.

Time Frame

2 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven L. Batki, MD

Organizational Affiliation

University of California, San Francisco/San Francisco VA Health Care System

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco VA Health Care System

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)

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