CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
Selegiline +1 moredrug
Likely dose
Selegiline 5 mg once daily for 1 week, then 5 mg twice daily for 6 weeks, then 5 mg once daily for 1 weekAI-extracted
Key inclusion· 6
  • Meets DSM-IV criteria for nicotine dependence with Fagerstrom Test of Nicotine Dependence (FTND) score greater than 5
  • Smokes at least 15 cigarettes daily (averaged over 1 week within the month prior to enrollment)
  • Motivated to quit smoking within 30 days at time of initial evaluation
  • At least one unsuccessful attempt to quit smoking in the past year
Key exclusion· 11
  • Currently taking sympathomimetic agents (e.g., pseudoephedrine, methylphenidate)
  • Currently taking antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion) or other monoamine oxidase inhibitors
  • Currently taking meperidine (Demerol)
  • Serious medical disorders such as unstable angina or liver failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00129311
NCT00129311Phase 2Completed

Usefulness of Selegiline for Smoking Cessation

Yale University·interventional·Posted Aug 11, 2005·Updated Mar 31, 2015

In Brief

A Phase 2 clinical trial evaluating Selegiline and Placebo for Tobacco Use Cessation. Completed, enrolled 101 participants across 1 site.

Detailed Summary

Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2005
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 20.9 years ago

Interventions

Selegilinedrug

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.

Placebodrug