Trial Outcomes & Findings for Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography (NCT NCT03314454)
NCT ID: NCT03314454
Last Updated: 2024-12-27
Results Overview
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink
TERMINATED
PHASE4
11 participants
60 days (from phone screening to follow-up retest)
2024-12-27
Participant Flow
We did not get far enough along with recruitment for this pilot study to recruit social drinkers, nor individuals with elevated mental status thus all participants recruited were considered to have heavy drinker status with non-elevated depressed mood, thus precluding comparisons between these groups.
As explained in recruitment details, enrollment for this pilot study ended early before social drinkers or participants with elevated mental status could be recruited, thus precluding group comparisons.
Participant milestones
| Measure |
Single Arm: Heavy Drinking Only With Elevated and Non-elevated Depressed Mood
We terminated this study early with only 10 of the projected 40 participants completing an alcohol administration laboratory session. We terminated the study before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group including only those with heavy drinking and both elevated and non-elevated depressed mood.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Single Arm: Heavy Drinking Only With Elevated and Non-elevated Depressed Mood
We terminated this study early with only 10 of the projected 40 participants completing an alcohol administration laboratory session. We terminated the study before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group including only those with heavy drinking and both elevated and non-elevated depressed mood.
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|---|---|
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
Baseline characteristics by cohort
| Measure |
Study Sample
n=10 Participants
We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race/ethnicity · White, non-Hispanic
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7 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race/ethnicity · Black, non-Hispanic
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/ethnicity · Asian, non-Hispanic
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 60 days (from phone screening to follow-up retest)Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink
Outcome measures
| Measure |
Study Sample
n=10 Participants
We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
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|---|---|
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Alcohol Topography: Sip Frequency
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14.67 sips per drink
Standard Deviation 7.57
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PRIMARY outcome
Timeframe: 60 days (from phone screening to follow-up retest)Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean interval between sips
Outcome measures
| Measure |
Study Sample
n=10 Participants
We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
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|---|---|
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Alcohol Topography: Sip Interval
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1.46 minutes
Standard Deviation 1.03
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PRIMARY outcome
Timeframe: 60 days (from phone screening to follow-up retest)Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean sip duration
Outcome measures
| Measure |
Study Sample
n=10 Participants
We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
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|---|---|
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Alcohol Topography: Sip Duration
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2.01 seconds
Standard Deviation 0.43
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PRIMARY outcome
Timeframe: 60 days (from phone screening to follow-up retest)Population: We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in multiple ways including the current measure: mean amount of beer consumed per sip
Outcome measures
| Measure |
Study Sample
n=10 Participants
We ended this study early, with only 10 of the projected 40 participants completing an alcohol administration laboratory session, before we could recruit social drinkers or participants with elevated mental status. For other classifications, subgroup sizes are too small for these results to have any meaning, thus we opted to present these results descriptively as a single group.
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Alcohol Topography: Sip Amount.
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32.35 grams per sip
Standard Deviation 19.84
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Adverse Events
Study Sample
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place