Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: Canadian Tobacco Control Research Initiative
• Treatments: Nicotine; Selegiline

Criteria

Inclusion Criteria:

• Meet DSM-IV criteria for nicotine dependence with FTND score > 5.

• Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month).

• At the time of initial evaluation, are motivated to quit smoking in the next 30 days.

• Have made at least one unsuccessful attempt to quit smoking in the past year.

• At baseline, have expired breath CO level > 10.

• Are between ages 18-70 years old.

• Weigh at least 100 lbs (45.5 kg, selegiline dose < 0.22 mg/kg).

• No previous use of nicotine replacement products in the one month prior to randomization.

• Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

• Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness.

• Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine).

• Demonstrate serious medical conditions (i.e. abnormal liver function [as evidenced by AST, ALT or bilirubin values 2x ULN], unstable cardiovascular disease, significant blood abnormalities).

• Exhibit or have history of clinical hypertension.

• Exhibit active peptic ulcer disease.

• Are pregnant, are trying to become pregnant, or are currently breastfeeding.

• Are on current medication regimes that include antidepressants, or sympathomimetic agents, or meperidine and other meperidine-opioids which may have interactions with selegiline.

• Known hypersensitivity to selegiline or NRT.

• Are from the same household as another study participant.