Trial Outcomes & Findings for Selegiline Patch for Treatment of Nicotine Dependence (NCT NCT01330030)

Results Overview

expired-air carbon monoxide confirmed smoking abstinence at 52 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

243 participants

Primary outcome timeframe

52 weeks

Results posted on

2016-08-10

The original target enrollment was 230. Over recruitment led to a study sample size =243

Participant milestones
Measure	Drug Selegiline 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks	Matching Placebo matching placebo worn 24 hours for 8 weeks
Overall Study STARTED	121	122
Overall Study COMPLETED	105	105
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal
Measure	Drug Selegiline 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks	Matching Placebo matching placebo worn 24 hours for 8 weeks
Overall Study Lost to Follow-up	16	17

Selegiline Patch for Treatment of Nicotine Dependence

Baseline characteristics by cohort
Measure	Drug Selegiline n=121 Participants 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Selegiline: 6mg/24 hrs for 8 weeks	Matching Placebo n=122 Participants matching placebo worn 24 hours for 8 weeks matching placebo: placebo/24hrs for 8 weeks	Total n=243 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	121 Participants n=5 Participants	122 Participants n=7 Participants	243 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	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	85 Participants n=7 Participants	169 Participants n=5 Participants
Region of Enrollment United States	121 participants n=5 Participants	122 participants n=7 Participants	243 participants n=5 Participants

Timeframe: 52 weeks

Population: intention to treat

expired-air carbon monoxide confirmed smoking abstinence at 52 weeks

Outcome measures
Measure	Drug Selegiline n=121 Participants 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Selegiline: 6mg/24 hrs for 8 weeks	Matching Placebo n=122 Participants matching placebo worn 24 hours for 8 weeks matching placebo: placebo/24hrs for 8 weeks
Expired-air Carbon Monoxide Confirmed Smoking Abstinence	24 participants not smoking	25 participants not smoking

Serious events: 0 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 108 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Drug Selegiline n=121 participants at risk 6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks Selegiline: 6mg/24 hrs for 8 weeks	Matching Placebo n=122 participants at risk matching placebo worn 24 hours for 8 weeks matching placebo: placebo/24hrs for 8 weeks
Psychiatric disorders Insomnia	47.1% 57/121 • Number of events 57	43.4% 53/122 • Number of events 53
General disorders Headache	33.9% 41/121 • Number of events 41	35.2% 43/122 • Number of events 43
Skin and subcutaneous tissue disorders skin rash	24.8% 30/121 • Number of events 30	22.1% 27/122 • Number of events 27
Psychiatric disorders racing thoughts	20.7% 25/121 • Number of events 25	23.0% 28/122 • Number of events 28
General disorders Lightheaded	16.5% 20/121 • Number of events 20	16.4% 20/122 • Number of events 20
Psychiatric disorders Vivid dreams	10.7% 13/121 • Number of events 13	9.8% 12/122 • Number of events 12

Stanford University

Phone: 650-723-5895