Trial Outcomes & Findings for Varenicline (Chantix™) for the Treatment of Alcohol Dependence (NCT NCT00705523)

Last Updated: 2015-06-02

Results Overview

Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

12 weeks of treatment and one month follow-up

Results posted on

2015-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Varenicline varenicline : 1.0 mg BID for 12 weeks	Placebo placebo : BID 12 weeks
Overall Study STARTED	19	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline varenicline : 1.0 mg BID for 12 weeks	Placebo placebo : BID 12 weeks
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Varenicline (Chantix™) for the Treatment of Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline n=19 Participants Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.	Placebo n=21 Participants placebo : BID 12 weeks	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	21 Participants n=4 Participants	40 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44.8 years STANDARD_DEVIATION 12.3 • n=93 Participants	48.1 years STANDARD_DEVIATION 10.5 • n=4 Participants	46.5 years STANDARD_DEVIATION 11.7 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	21 participants n=4 Participants	40 participants n=27 Participants
ASI Alcohol Composite Score, Baseline	0.61 Alcohol Composite Score STANDARD_DEVIATION 0.16 • n=93 Participants	0.60 Alcohol Composite Score STANDARD_DEVIATION 0.15 • n=4 Participants	0.61 Alcohol Composite Score STANDARD_DEVIATION 0.16 • n=27 Participants
Days of Alcohol Use in Past 30 Days	18.4 Drinking Days STANDARD_DEVIATION 8.8 • n=93 Participants	17.6 Drinking Days STANDARD_DEVIATION 9.1 • n=4 Participants	18.0 Drinking Days STANDARD_DEVIATION 8.95 • n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks of treatment and one month follow-up

Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).

Outcome measures

Outcome measures
Measure	Varenicline n=19 Participants Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.	Placebo n=21 Participants placebo : BID 12 weeks
Rate of Heavy Drinking Days Per Week.	.89 rate of heavy drinking days per week Standard Deviation .18	1.21 rate of heavy drinking days per week Standard Deviation .31

SECONDARY outcome

Timeframe: 12 weeks of treatment, with a follow-up one month after treatment

The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.

Outcome measures

Outcome measures
Measure	Varenicline n=19 Participants Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.	Placebo n=21 Participants placebo : BID 12 weeks
Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.	0.12 alcohol composite score Standard Deviation 0.20	0.29 alcohol composite score Standard Deviation 0.23

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Varenicline n=19 participants at risk varenicline : 1.0 mg BID for 12 weeks	Placebo n=21 participants at risk placebo : BID 12 weeks
General disorders Headache	26.3% 5/19 • Number of events 5	14.3% 3/21 • Number of events 3
General disorders Body aches/paines	26.3% 5/19 • Number of events 5	19.0% 4/21 • Number of events 4
Psychiatric disorders PTSD-like episode	5.3% 1/19 • Number of events 1	0.00% 0/21
General disorders Blood pressure elevation	5.3% 1/19 • Number of events 1	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Diarrhea	21.1% 4/19 • Number of events 7	9.5% 2/21 • Number of events 3
General disorders Cough	5.3% 1/19 • Number of events 1	4.8% 1/21 • Number of events 1
General disorders Nighmare	10.5% 2/19 • Number of events 3	0.00% 0/21
Psychiatric disorders Depressed mood	10.5% 2/19 • Number of events 4	9.5% 2/21 • Number of events 2
Gastrointestinal disorders Nausea	15.8% 3/19 • Number of events 4	14.3% 3/21 • Number of events 3
General disorders Insomnia	10.5% 2/19 • Number of events 2	9.5% 2/21 • Number of events 2
Psychiatric disorders Anxiety	5.3% 1/19 • Number of events 1	9.5% 2/21 • Number of events 2
General disorders Vivid dreams	21.1% 4/19 • Number of events 4	14.3% 3/21 • Number of events 3

Additional Information

Dr. Jennifer Plebani

UPenn

Phone: 215-222-3200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place