Trial Outcomes & Findings for A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence (NCT NCT01011907)

NCT ID: NCT01011907

Last Updated: 2013-02-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: Weeks 1-12
• Results posted on: 2013-02-25

Participant Flow

99 subjects were consented of which 64 successfully completed the screening process were randomized to treatment. Results are posted for the 35 subjects who completed the study.

Participant milestones

Measure	Placebo Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Overall Study STARTED	31	33
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Measure	Placebo Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Overall Study Withdrawal by Subject	13	11
Overall Study Adverse Event	1	4

Baseline Characteristics

A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

Baseline characteristics by cohort

Measure	Placebo n=17 Participants	Varenicline n=18 Participants	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 1-12

Outcome measures

Measure	Placebo n=17 Participants Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline n=18 Participants Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.	788.94 cigarettes Standard Error 96.27	403.24 cigarettes Standard Error 102.42

SECONDARY outcome

Timeframe: Weeks 1-12

Outcome measures

Measure	Placebo n=17 Participants Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline n=17 Participants Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.	277.5 drinks Standard Error 41.9	177.04 drinks Standard Error 28.86

SECONDARY outcome

Timeframe: Week 1 to Week 12

Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.

Outcome measures

Measure	Placebo n=17 Participants Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline n=18 Participants Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.	-3.07 Scores on a scale Standard Error 0.389	-4.36 Scores on a scale Standard Error 0.205

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Varenicline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=31 participants at risk Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily). placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).	Varenicline n=33 participants at risk Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84). varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
Psychiatric disorders Suicidal ideation	3.2% 1/31 • Number of events 1	0.00% 0/33

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Mitchell, Clinical Project Director

UCSF: EGCRC

Phone: 510-985-3100

Email: jmitchell@gallo.ucsf.edu

Results disclosure agreements

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