Nicotine Dependence Clinical Trial
Official title:
Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
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.
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. After successful completion of 3 screening visits (to ensure
medical and psychiatric eligibility criteria are met), subjects will be randomized into one
of two experimental groups:
1. selegiline (10 mg/day) + NRT (21 mg/24 hr)
2. matching placebo + NRT (21 mg/24 hr)
Randomization will be performed through the use a random number list to generate 50%
selegiline/50% placebo and also 50% male/50% female within each of those treatment groups.
Participants will begin selegiline (or placebo) once a day during Week 1, and dose will be
graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m.
dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal
nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in
conjunction with study medication for Weeks 3-8, after which the patch will be removed and
study medication tapered throughout Week 9.
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide
breath, urine and blood samples as required, receive brief smoking cessation counseling and
complete questionnaires regarding their smoking behavior and psychological state. A
post-trial physical will be conducted upon completion of Week 9. Monthly follow-up phone
interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a
6-month follow-up.
Trial Objectives
1. To determine if combination of selegiline hydrochloride and NRT (full substitution to
tobacco) is superior to NRT alone + placebo (partial substitution) for smoking
cessation in nicotine dependent smokers.
- The primary hypothesis is that full substitution (selegiline + NRT) will be
superior to placebo + NRT for achievement of 7-day point prevalence smoking
abstinence rates at the end of trial abstinence rates (Day 49-56) assessment in
nicotine-dependent cigarette smokers.
- Secondary hypothesis 1a is that full substitution (selegiline + NRT) will be
superior to NRT for achievement of last four weeks of trial (Days 29-56) smoking
abstinence rates in nicotine-dependent cigarette smokers.
- Secondary hypothesis 1b is that full substitution (selegiline + NRT) will be
superior to NRT for achievement 6-month post target quit date smoking abstinence
rates in nicotine-dependent cigarette smokers.
2. To determine if treatment retention and study medication compliance will be higher in
the full substitution (selegiline + NRT) group as compared to the NRT group during the
8-week smoking cessation trial.
Hypothesis 2 is that treatment retention and study medication compliance will be higher
in the full substitution (selegiline + NRT) group as compared to the NRT group during
the 8-week smoking cessation trial.
3. To determine if full substitution (selegiline + NRT) reduces nicotine craving and
withdrawal symptoms as compared to NRT group during the 8-week smoking cessation trial.
Hypothesis 3 is that full substitution treatment will lead to significant reductions in
tobacco withdrawal and craving ratings compared to NRT group.
4. To determine adverse events profile in nicotine-dependent smokers of the combination of
selegiline and NRT as compared to NRT.
Hypothesis 4 is that selegiline in combination with NRT will be well-tolerated and that
rates of adverse events will not be significantly different between subjects assigned to
full substitution as compared to NRT group.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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