Trial Outcomes & Findings for Usefulness of Selegiline as an Aid to Quit Smoking - 1 (NCT NCT00129311)

NCT ID: NCT00129311

Last Updated: 2015-03-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 101 participants
• Primary outcome timeframe: 6-month follow up
• Results posted on: 2015-03-31

Participant Flow

Participant milestones

Measure	Selegiline Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
Overall Study STARTED	51	50
Overall Study COMPLETED	39	31
Overall Study NOT COMPLETED	12	19

Reasons for withdrawal

Measure	Selegiline Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
Overall Study Withdrawal by Subject	12	19

Baseline Characteristics

Usefulness of Selegiline as an Aid to Quit Smoking - 1

Baseline characteristics by cohort

Measure	Selegiline n=51 Participants Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo n=50 Participants Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Total n=101 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	46.2 years STANDARD_DEVIATION 13.0 • n=7 Participants	47.4 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants
Education	13.8 years STANDARD_DEVIATION 2.0 • n=5 Participants	14.2 years STANDARD_DEVIATION 2.2 • n=7 Participants	14.0 years STANDARD_DEVIATION 2.1 • n=5 Participants
Age of Smoking Onset	16.2 years STANDARD_DEVIATION 6.9 • n=5 Participants	16.3 years STANDARD_DEVIATION 4.1 • n=7 Participants	16.3 years STANDARD_DEVIATION 5.6 • n=5 Participants
Duration of Smoking (years)	31.6 years STANDARD_DEVIATION 11.6 • n=5 Participants	29.8 years STANDARD_DEVIATION 13.6 • n=7 Participants	30.7 years STANDARD_DEVIATION 12.6 • n=5 Participants

PRIMARY outcome

Timeframe: 6-month follow up

Outcome measures

Measure	Selegiline n=51 Participants Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo n=50 Participants Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
7 Day Point Prevalence of Cigarette Abstinence	6 participants	8 participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Measure	Selegiline n=51 Participants Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo n=50 Participants Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
7 Day Point Prevalence of Cigarette Abstinence	8 participants	10 participants

Adverse Events

Selegiline

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Selegiline n=51 participants at risk Selegiline Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.	Placebo n=50 participants at risk Placebo Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks.
General disorders Dry Mouth	25.5% 13/51	8.0% 4/50
General disorders Flu Like Symptoms	21.6% 11/51	8.0% 4/50
General disorders Irregular or Rapid Heartbeat	17.6% 9/51	10.0% 5/50
General disorders Headaches	47.1% 24/51	42.0% 21/50
General disorders Drowsiness	39.2% 20/51	32.0% 16/50

Additional Information

Dr. Andrea Weinberger

Yale Unviersity

Phone: 203-974-7598

Email: andrea.weinberger@yale.edu

Results disclosure agreements

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