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Selegiline for Smoking Cessation - 1

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ClinicalTrials.gov Identifier: NCT00439413
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : October 13, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: Selegiline Transdermal Patch
Drug: Placebo
Behavioral: Smoking Cessation Counseling
Enrollment 246
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Selegiline Transdermal System Placebo
Hide Arm/Group Description Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
Period Title: Overall Study
Started 121 125
Completed 90 88
Not Completed 31 37
Arm/Group Title Selegiline Transdermal System Placebo Total
Hide Arm/Group Description Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks Total of all reporting groups
Overall Number of Baseline Participants 121 125 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 125 participants 246 participants
45.6  (14.2) 47.3  (13.6) 46.5  (14)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
Female
62
  51.2%
59
  47.2%
121
  49.2%
Male
59
  48.8%
66
  52.8%
125
  50.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
American Indian or Alaska Native
0
   0.0%
3
   2.4%
3
   1.2%
Asian
6
   5.0%
5
   4.0%
11
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  24.0%
30
  24.0%
59
  24.0%
White
86
  71.1%
87
  69.6%
173
  70.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 121 participants 125 participants 246 participants
121 125 246
1.Primary Outcome
Title Quit Rate
Hide Description 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).
Time Frame Study weeks 6 through 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selegiline Transdermal System Matching Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 121 125
Measure Type: Number
Unit of Measure: participants
18 15
2.Secondary Outcome
Title Abstinence
Hide Description 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.
Time Frame week 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selegiline Transdermal System Placebo
Hide Arm/Group Description:
Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
Overall Number of Participants Analyzed 121 125
Measure Type: Number
Unit of Measure: participants
16 10
Time Frame Week 2 through 9 and follow-up weeks (10 and 14)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Selegiline Transdermal System Matching Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Selegiline Transdermal System Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Selegiline Transdermal System Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/121 (2.48%)      0/125 (0.00%)    
Cardiac disorders     
Heart Attack   1/121 (0.83%)  1 0/125 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fracture of femur   1/121 (0.83%)  1 0/125 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Exacerbation of COPD dut to pneumonia   1/121 (0.83%)  1 0/125 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Selegiline Transdermal System Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   99/121 (81.82%)      76/125 (60.80%)    
Blood and lymphatic system disorders     
Anaemia   0/121 (0.00%)  0 1/125 (0.80%)  1
Cardiac disorders     
Palpitations   1/121 (0.83%)  1 1/125 (0.80%)  1
Ear and labyrinth disorders     
Ear pain   2/121 (1.65%)  2 2/125 (1.60%)  2
Endocrine disorders     
Hypothyroidism   1/121 (0.83%)  1 0/125 (0.00%)  0
Eye disorders     
Vision blurred   2/121 (1.65%)  2 0/125 (0.00%)  0
Gastrointestinal disorders     
Dry Mouth   9/121 (7.44%)  9 5/125 (4.00%)  5
General disorders     
Application Site Erythema   13/121 (10.74%)  14 4/125 (3.20%)  4
Hepatobiliary disorders     
Hypersensitivity   1/121 (0.83%)  1 1/125 (0.80%)  1
Infections and infestations     
Nasopharyngitis   6/121 (4.96%)  7 7/125 (5.60%)  8
Injury, poisoning and procedural complications     
Fall   0/121 (0.00%)  0 2/125 (1.60%)  5
Investigations     
Blood pressure increased   1/121 (0.83%)  2 2/125 (1.60%)  2
Metabolism and nutrition disorders     
Decreased appetite   5/121 (4.13%)  5 1/125 (0.80%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity   4/121 (3.31%)  4 3/125 (2.40%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant   0/121 (0.00%)  0 1/125 (0.80%)  1
Nervous system disorders     
Headache   18/121 (14.88%)  23 24/125 (19.20%)  35
Psychiatric disorders     
Insomnia   19/121 (15.70%)  19 10/125 (8.00%)  12
Renal and urinary disorders     
Pollakiuria   1/121 (0.83%)  1 0/125 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea   2/121 (1.65%)  2 2/125 (1.60%)  2
Respiratory, thoracic and mediastinal disorders     
Cough   7/121 (5.79%)  7 8/125 (6.40%)  9
Skin and subcutaneous tissue disorders     
Skin irritation   3/121 (2.48%)  3 1/125 (0.80%)  1
Surgical and medical procedures     
Tooth extraction   4/121 (3.31%)  4 0/125 (0.00%)  0
Vascular disorders     
Hot flush   0/121 (0.00%)  0 1/125 (0.80%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Liza Zeinert
Organization: National Institute on Drug Abuse
Phone: 301-443-1138
EMail: liza.zeinert@nih.gov
Layout table for additonal information
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00439413    
Obsolete Identifiers: NCT00462514
Other Study ID Numbers: NIDA-CSP-1022-1
First Submitted: February 22, 2007
First Posted: February 23, 2007
Results First Submitted: August 17, 2016
Results First Posted: October 13, 2016
Last Update Posted: February 2, 2017