Trial Outcomes & Findings for Varenicline and Alcohol in Inpatient Addictions Program (IAP) (NCT NCT01169610)
NCT ID: NCT01169610
Last Updated: 2019-03-20
Results Overview
No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.
TERMINATED
PHASE3
1 participants
Two years
2019-03-20
Participant Flow
Recruitment period 1/2011 - 9/2012
Participant milestones
| Measure |
Open Label
Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
data not analyzed for 1 participant enrolled
Baseline characteristics by cohort
| Measure |
Open Label
n=1 Participants
Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=1 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=1 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Two yearsPopulation: Data not analyzed for 1 participant enrolled
No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two yearsPopulation: data not analyzed for 1 participant enrolled
Number of drinking days \> 5 drinks/day for men and \> 4 drink/day for women. This will be a self-reported outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two yearsPopulation: data not analyzed for 1 participant enrolled
Negative response to the question, "Have you used any type of tobacco, even a puff, in the past 7 days." This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) \< 8 parts per million (ppm) during the medication phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two yearsPopulation: data not analyzed for 1 participant enrolled
Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, "Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?" Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD). Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two yearsPopulation: data not analyzed for 1 participant enrolled
Tolerability will be defined by the number of adverse events experienced by patients.
Outcome measures
Outcome data not reported
Adverse Events
Open Label
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