Phase 2
N=246
Selegiline for Smoking Cessation - 1
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00439413 ↗Enrolled (actual)
246
Serious AEs
1.2%
Results posted
Oct 2016
Primary outcome: Primary: Quit Rate — 18; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Selegiline Transdermal Patch (Drug); Placebo (Drug); Smoking Cessation Counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quit Rate |
18; 15 | — |
| SECONDARY Abstinence |
16; 10 | — |
Summary
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years of age
- Be in good general health
- Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
- Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
- Subjects must be motivated to quite smoking
- If female and of child bearing potential, agrees to use birth control and subject
- Subject must be able to understand and provide written informed consent.
Exclusion
Criteria:
- Please contact site for more information
Data sourced from ClinicalTrials.gov (NCT00439413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.