Trial Outcomes & Findings for Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders (NCT NCT01000987)

Last Updated: 2018-02-19

Results Overview

Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.

Results posted on

2018-02-19

Participant Flow

Of the n=60 subjects who completed the parent study (NCT00580645), n=44 elected to also complete the current protocol.

Participant milestones

Participant milestones
Measure	1 mg/Day Varenicline varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	2 mg/Day Varenicline varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	Placebo placebo placebo: placebo
Overall Study STARTED	12	15	17
Overall Study COMPLETED	12	15	17
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 mg/Day Varenicline n=12 Participants varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	2 mg/Day Varenicline n=15 Participants varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	Placebo n=17 Participants placebo placebo: placebo	Total n=44 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 7.29 • n=5 Participants	34.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	35.3 years STANDARD_DEVIATION 9.47 • n=5 Participants	34.6 years STANDARD_DEVIATION 9.96 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.

Outcome measures

Outcome measures
Measure	1 mg/Day Varenicline n=12 Participants varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	2 mg/Day Varenicline n=15 Participants varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	Placebo n=17 Participants placebo placebo: placebo
Cognitive Function as Measured by Omissions on the CPT Alcohol	1.78 Number of Omissions Standard Error 1.24	1.28 Number of Omissions Standard Error 1.11	4.76 Number of Omissions Standard Error 1.05
Cognitive Function as Measured by Omissions on the CPT Control Beverage	0.98 Number of Omissions Standard Error 1.24	0.62 Number of Omissions Standard Error 1.11	2.37 Number of Omissions Standard Error 1.05

Adverse Events

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

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1 mg/Day Varenicline n=20 participants at risk varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	2 mg/Day Varenicline n=20 participants at risk varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.	Placebo n=20 participants at risk placebo placebo: placebo
Gastrointestinal disorders Constipation	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	10.0% 2/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
Gastrointestinal disorders Nausea/Vomiting	20.0% 4/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	25.0% 5/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	30.0% 6/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Dry Mouth	10.0% 2/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	10.0% 2/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	35.0% 7/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Insomnia	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	25.0% 5/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	10.0% 2/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
Gastrointestinal disorders Flatulence	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Difficulty Breathing	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Shortness of Breath	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
Cardiac disorders Tightness in Chest	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Abnormal Dreams	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	15.0% 3/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	10.0% 2/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
Cardiac disorders Fast Heartbeat	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	15.0% 3/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	5.0% 1/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Suicidal Thoughts	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.
General disorders Erratic Behavior	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.	0.00% 0/20 • During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645). 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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 8.

Additional Information

Sherry McKee PhD

Yale University

Phone: 203-737-3529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place