Trial Outcomes & Findings for Selegiline for Smoking Cessation - 1 (NCT NCT00439413)

Last Updated: 2017-02-02

Results Overview

The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

246 participants

Primary outcome timeframe

Study weeks 6 through 9

Results posted on

2017-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Selegiline Transdermal System Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks	Placebo Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
Overall Study STARTED	121	125
Overall Study COMPLETED	90	88
Overall Study NOT COMPLETED	31	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selegiline for Smoking Cessation - 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selegiline Transdermal System n=121 Participants Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks	Placebo n=125 Participants Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks	Total n=246 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 14.2 • n=5 Participants	47.3 years STANDARD_DEVIATION 13.6 • n=7 Participants	46.5 years STANDARD_DEVIATION 14 • n=5 Participants
Gender Female	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Gender Male	59 Participants n=5 Participants	66 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	5 Participants n=7 Participants	11 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	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	87 Participants n=7 Participants	173 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	121 participants n=5 Participants	125 participants n=7 Participants	246 participants n=5 Participants

PRIMARY outcome

Timeframe: Study weeks 6 through 9

Outcome measures

Outcome measures
Measure	Selegiline Transdermal System n=121 Participants Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.	Matching Placebo n=125 Participants Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.
Quit Rate	18 participants	15 participants

SECONDARY outcome

Timeframe: week 14

The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.

Outcome measures

Outcome measures
Measure	Selegiline Transdermal System n=121 Participants Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.	Matching Placebo n=125 Participants Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.
Abstinence	16 participants	10 participants

Adverse Events

Selegiline Transdermal System

Serious events: 3 serious events

Other events: 99 other events

Deaths: 0 deaths

Matching Placebo

Serious events: 0 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Selegiline Transdermal System n=121 participants at risk Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.	Matching Placebo n=125 participants at risk Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.
Musculoskeletal and connective tissue disorders Fracture of femur	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)
Cardiac disorders Heart Attack	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)
Respiratory, thoracic and mediastinal disorders Exacerbation of COPD dut to pneumonia	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)

Other adverse events

Additional Information

Liza Zeinert

National Institute on Drug Abuse

Phone: 301-443-1138

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Selegiline Transdermal System n=121 participants at risk Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.	Matching Placebo n=125 participants at risk Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase. During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks. Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks.
Nervous system disorders Headache	14.9% 18/121 • Number of events 23 • Week 2 through 9 and follow-up weeks (10 and 14)	19.2% 24/125 • Number of events 35 • Week 2 through 9 and follow-up weeks (10 and 14)
General disorders Application Site Erythema	10.7% 13/121 • Number of events 14 • Week 2 through 9 and follow-up weeks (10 and 14)	3.2% 4/125 • Number of events 4 • Week 2 through 9 and follow-up weeks (10 and 14)
Gastrointestinal disorders Dry Mouth	7.4% 9/121 • Number of events 9 • Week 2 through 9 and follow-up weeks (10 and 14)	4.0% 5/125 • Number of events 5 • Week 2 through 9 and follow-up weeks (10 and 14)
Respiratory, thoracic and mediastinal disorders Cough	5.8% 7/121 • Number of events 7 • Week 2 through 9 and follow-up weeks (10 and 14)	6.4% 8/125 • Number of events 9 • Week 2 through 9 and follow-up weeks (10 and 14)
Psychiatric disorders Insomnia	15.7% 19/121 • Number of events 19 • Week 2 through 9 and follow-up weeks (10 and 14)	8.0% 10/125 • Number of events 12 • Week 2 through 9 and follow-up weeks (10 and 14)
Infections and infestations Nasopharyngitis	5.0% 6/121 • Number of events 7 • Week 2 through 9 and follow-up weeks (10 and 14)	5.6% 7/125 • Number of events 8 • Week 2 through 9 and follow-up weeks (10 and 14)
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 4/121 • Number of events 4 • Week 2 through 9 and follow-up weeks (10 and 14)	2.4% 3/125 • Number of events 5 • Week 2 through 9 and follow-up weeks (10 and 14)
Skin and subcutaneous tissue disorders Skin irritation	2.5% 3/121 • Number of events 3 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Injury, poisoning and procedural complications Fall	0.00% 0/121 • Week 2 through 9 and follow-up weeks (10 and 14)	1.6% 2/125 • Number of events 5 • Week 2 through 9 and follow-up weeks (10 and 14)
Investigations Blood pressure increased	0.83% 1/121 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)	1.6% 2/125 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)
Metabolism and nutrition disorders Decreased appetite	4.1% 5/121 • Number of events 5 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Surgical and medical procedures Tooth extraction	3.3% 4/121 • Number of events 4 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)
Ear and labyrinth disorders Ear pain	1.7% 2/121 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)	1.6% 2/125 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)
Eye disorders Vision blurred	1.7% 2/121 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)
Reproductive system and breast disorders Dysmenorrhoea	1.7% 2/121 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)	1.6% 2/125 • Number of events 2 • Week 2 through 9 and follow-up weeks (10 and 14)
Hepatobiliary disorders Hypersensitivity	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Cardiac disorders Palpitations	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Vascular disorders Hot flush	0.00% 0/121 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Blood and lymphatic system disorders Anaemia	0.00% 0/121 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Endocrine disorders Hypothyroidism	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/121 • Week 2 through 9 and follow-up weeks (10 and 14)	0.80% 1/125 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)
Renal and urinary disorders Pollakiuria	0.83% 1/121 • Number of events 1 • Week 2 through 9 and follow-up weeks (10 and 14)	0.00% 0/125 • Week 2 through 9 and follow-up weeks (10 and 14)