Trial Outcomes & Findings for Do Treatments for Smoking Cessation Affect Alcohol Drinking? (NCT NCT00580645)

NCT ID: NCT00580645

Last Updated: 2018-02-07

Results Overview

number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
• Results posted on: 2018-02-07

Participant Flow

Participant milestones

Measure	Placebo Placebo controlled placebo: placebo	1 mg/Day Varenicline 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	2 mg/Day Varenicline 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Baseline characteristics by cohort

Measure	Placebo n=20 Participants Placebo controlled placebo: placebo	1 mg/Day Varenicline n=20 Participants 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	2 mg/Day Varenicline n=20 Participants 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	Total n=60 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 9.52 • n=5 Participants	33.35 years STANDARD_DEVIATION 8.51 • n=7 Participants	34.15 years STANDARD_DEVIATION 11.6 • n=5 Participants	33.90 years STANDARD_DEVIATION 9.80 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 hour ad-lib drinking period, during the laboratory session (Day 8)

Population: number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session

number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session

Outcome measures

Measure	Placebo n=20 Participants Placebo controlled placebo: placebo	1 mg/Day Varenicline n=20 Participants 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	2 mg/Day Varenicline n=20 Participants 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Number of Drinks Consumed hour 1	2.1 number of drinks Standard Error 0.37	2.05 number of drinks Standard Error 0.32	1.5 number of drinks Standard Error 0.33
Number of Drinks Consumed hour 2	1.7 number of drinks Standard Error 0.37	2.05 number of drinks Standard Error 0.37	1.5 number of drinks Standard Error 0.37

SECONDARY outcome

Timeframe: during laboratory session (Day 8) at baseline

Population: n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure.

alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)

Outcome measures

Measure	Placebo n=20 Participants Placebo controlled placebo: placebo	1 mg/Day Varenicline n=20 Participants 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	2 mg/Day Varenicline n=19 Participants 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Alcohol Craving	37.24 units on a visual analog scale Standard Error 5.32	34.11 units on a visual analog scale Standard Error 5.32	24.04 units on a visual analog scale Standard Error 5.33

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

1 mg/Day Varenicline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

2 mg/Day Varenicline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=20 participants at risk Placebo controlled placebo: placebo	1 mg/Day Varenicline n=20 participants at risk 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.	2 mg/Day Varenicline n=20 participants at risk 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
Gastrointestinal disorders Constipation	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	10.0% 2/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
Gastrointestinal disorders Nausea	30.0% 6/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	20.0% 4/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	25.0% 5/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Dry Mouth	35.0% 7/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	10.0% 2/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	10.0% 2/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Insomnia	10.0% 2/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	25.0% 5/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
Gastrointestinal disorders Flatulence	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Difficulty Breathing	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Shortness of Breath	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
Cardiac disorders Tightness in Chest	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Abnormal Dreams	10.0% 2/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	15.0% 3/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
Cardiac disorders Fast Heartbeat	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	5.0% 1/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	15.0% 3/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Suicidal Thoughts	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.
General disorders Erratic Behavior	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.	0.00% 0/20 • Titration period (8 days). All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.

Additional Information

Sherry McKee PhD

Yale School of Medicine

Phone: 203-737-3529

Email: sherry.mckee@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place