Phase 2
Completed N=101
Usefulness of Selegiline as an Aid to Quit Smoking - 1
Tobacco Use Cessation
Source: ClinicalTrials.gov NCT00129311 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: 7 Day Point Prevalence of Cigarette Abstinence — 6; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7 Day Point Prevalence of Cigarette Abstinence |
8; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV criteria for nicotine dependence with a 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
- An expired breath CO level greater than 10 ppm and baseline plasma cotinine level greater than 150 ng/ml at initial evaluation
- Body weight of at least 100 lb
- Avoidance of nicotine replacement product use one month prior to enrollment
- Speaks English
Exclusion Criteria
- Currently taking over-the-counter or prescription sympathomimetic agents (e.g., pseudoephedrine, methylphenidate), antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (Demerol)
- Serious medical disorders such as unstable angina or liver failure
- Abnormalities in baseline bloodwork (e.g., threefold elevation of liver function tests, electrolyte abnormalities)
- Physiologically dependent on and/or abusing alcohol or other drugs of abuse (e.g., cocaine, opiates, benzodiazepines, etc.) during the 6 months prior to enrollment (based on a clinical evaluation, which includes a self-report, and is confirmed by a positive urine toxicology screen)
- Meets DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder, or post-traumatic stress disorder
- Current or past history of bipolar disorder or schizophrenia
- Past history of major depression associated with historical evidence of suicidal or homicidal behavior, or psychotic symptoms
- Currently residing with another study participant
- Presence of suicidal or homicidal ideation
- Significant impairment of social or occupational functioning, either at time of initial evaluation or during the trial
- Known hypersensitivity to selegiline hydrochloride
Data sourced from ClinicalTrials.gov (NCT00129311). 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. Informational only — not medical advice.