Usefulness of Selegiline as an Aid to Quit Smoking - 1
Condition: Tobacco Use Cessation
Intervention: Selegiline; Placebo
Intervention description: 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.
Intervention MeSH terms: Selegiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tobacco

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.
    

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