Status:
TERMINATED
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Canadian Tobacco Control Research Initiative
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 nicot...
Detailed Description
This pilot study utilizes a double-blind, two-armed design to evaluate the efficacy of combining oral selegiline with transdermal nicotine patch for smoking cessation in 40 nicotine-dependent smokers....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00390923
Start Date
July 1 2007
End Date
April 1 2008
Last Update
August 29 2013
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1