Trial Outcomes & Findings for Relapse Prevention With Varenicline (NCT NCT00944554)

NCT ID: NCT00944554

Last Updated: 2017-08-03

Results Overview

Number of days following the programmed lapse exposure until relapse to smoking occurred

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 104 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2017-08-03

Participant Flow

Participant milestones

Measure	Placebo Group given placebo twice a day for 5 weeks.	Varenicline Experimental group given varenicline twice a day or five weeks.
Overall Study STARTED	50	54
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	28	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relapse Prevention With Varenicline

Baseline characteristics by cohort

Measure	Placebo n=50 Participants Group given placebo. Placebo: Varenicline and placebo given twice a day or five weeks.	Varenicline n=54 Participants Experimental group given varenicline dosing. Varenicline: Varenicline and placebo given twice a day or five weeks.	Total n=104 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 10 • n=5 Participants	45 years STANDARD_DEVIATION 12 • n=7 Participants	44 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	32 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	22 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	50 Participants n=5 Participants	54 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	54 participants n=7 Participants	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Number of days following the programmed lapse exposure until relapse to smoking occurred

Outcome measures

Measure	Placebo n=22 Participants Group given placebo twice a day or five weeks.	Varenicline n=25 Participants Experimental group given varenicline twice a day or five weeks.
Days to Relapse	9.1 days Standard Deviation 9.7	16.4 days Standard Deviation 10.3

Adverse Events

Placebo

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maxine Stitzer, PhD

Johns Hopkins University

Phone: 410-550-0042

Email: mstitze1@jhmi.edu

Results disclosure agreements

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