Trial Outcomes & Findings for Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD) (NCT NCT03898323)
NCT ID: NCT03898323
Last Updated: 2024-06-18
Results Overview
Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
COMPLETED
NA
3 participants
6 weeks
2024-06-18
Participant Flow
Participant milestones
| Measure |
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 2 weeks, for a total of 6 sessions.
Alcohol Approach Bias Modification: Computerized training
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Overall Study
STARTED
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3
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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 2 weeks, for a total of 6 sessions.
Alcohol Approach Bias Modification: Computerized training
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)
Baseline characteristics by cohort
| Measure |
AABM Training
n=3 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=39 Participants
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Age, Categorical
>=65 years
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0 Participants
n=39 Participants
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Sex: Female, Male
Female
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0 Participants
n=39 Participants
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Sex: Female, Male
Male
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3 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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2 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=39 Participants
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Race (NIH/OMB)
White
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2 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Region of Enrollment
United States
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3 participants
n=39 Participants
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PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population consists of the target number (12) of participants that the investigators hoped to recruit and start on study treatment over a 12-month period. There appears to be an inconsistency only because the actual number of participants recruited and started on study treatment over the 12-month period was only 3.
The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.
Outcome measures
| Measure |
AABM Training
n=12 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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Recruitment Feasibility
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3 Participants
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PRIMARY outcome
Timeframe: 6 weeksRetention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.
Outcome measures
| Measure |
AABM Training
n=3 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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|---|---|
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Retention Feasibility
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2 Participants
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PRIMARY outcome
Timeframe: 6 weeksTolerability feasibility is measured by the number and percent of participants experiencing each adverse event.
Outcome measures
| Measure |
AABM Training
n=3 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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Tolerability Feasibility
Head tingling
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1 Participants
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Tolerability Feasibility
Physically slow
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1 Participants
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Tolerability Feasibility
Sleepiness
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2 Participants
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Tolerability Feasibility
Dizziness
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1 Participants
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Tolerability Feasibility
Itchy/red eyes
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1 Participants
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SECONDARY outcome
Timeframe: 6 weeksPopulation: One participant did not complete the either ADP session.
Alcohol craving will be measured during ADP sessions 1 and 2 using the Alcohol Urge Questionnaire (AUQ). Alcohol craving will be measured during Alcohol Drinking Paradigm (ADP) sessions 1 and 2, using the total score of the Alcohol Urge Questionnaire (AUQ). The AUQ has 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7; items 2 and 7 are reverse scored). Higher scores reflect greater craving. Total score range is from a minimum of 8 to a maximum of 56. The AUQ is administered before alcohol administration and at various times after alcohol administration. The AUQ score reported here is the highest AUQ score obtained for that ADP session.
Outcome measures
| Measure |
AABM Training
n=2 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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Alcohol Craving
ADP 1
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27.3 score on a scale
Standard Deviation 6.3
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Alcohol Craving
ADP 2
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23.3 score on a scale
Standard Deviation 2.6
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SECONDARY outcome
Timeframe: 2 days (1 day each for ADP session 1 and 2)Population: One participant did not complete the either ADP session.
Alcohol consumption will be measured during ADP sessions 1 and 2 using the number of alcoholic standard drinks consumed during ADP session 1 (before 2 weeks of AABM training) and ADP session 2 (after the 2 weeks of AABM training). Consumption was measured using the number of alcoholic standard drinks consumed during the ADP sessions. A standard drink per NIAAA definition is 14 grams of pure alcohol.
Outcome measures
| Measure |
AABM Training
n=2 Participants
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.
Alcohol Approach Bias Modification: Computerized training
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Alcohol Consumption (Number of Standard Drinks Consumed)
ADP 1
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1.5 standard drinks
Standard Deviation 2.12
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Alcohol Consumption (Number of Standard Drinks Consumed)
ADP 2
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0.5 standard drinks
Standard Deviation 0.71
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Adverse Events
AABM Training With ADP Sessions Before and After Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AABM Training With ADP Sessions Before and After Training
n=3 participants at risk
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.
Alcohol Approach Bias Modification: Computerized training
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Nervous system disorders
Head tingling
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33.3%
1/3 • Number of events 1 • Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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General disorders
Physically slow
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33.3%
1/3 • Number of events 1 • Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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General disorders
Sleepiness/tiredness
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66.7%
2/3 • Number of events 2 • Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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Nervous system disorders
Dizziness
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33.3%
1/3 • Number of events 1 • Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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Eye disorders
Itchy/red eyes
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33.3%
1/3 • Number of events 1 • Beginning at baseline through the follow-up visit, for a total of 6 weeks.
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Additional Information
Steven L. Batki, MD
University of California, San Francisco/San Francisco VA Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place