Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Centre for Addiction and Mental Health Canadian Tobacco Control Research Initiative |
---|---|
Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00390923 |
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.
Condition | Intervention |
---|---|
Nicotine Dependence |
Drug: Selegiline + nicotine replacement therapy Drug: placebo + nicotine replacement therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence |
Estimated Enrollment: | 40 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Selegiline + nicotine replacement therapy
Participants will begin selegiline 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.
|
2: Placebo Comparator |
Drug: placebo + nicotine replacement therapy
Participants will begin 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.
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Centre for Addiction and Mental Health | |
Toronto, Ontario, Canada, M5S 2S1 |
Principal Investigator: | Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( Bernard Le Foll ) |
Study ID Numbers: | 170/2006 |
Study First Received: | October 19, 2006 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00390923 |
Health Authority: | Canada: Health Canada |
smoking nicotine dependence double-blind placebo-controlled |
randomized full substitution therapy selegiline |
Nicotine polacrilex Selegiline Smoking Nicotine |
Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nicotinic Agonists Physiological Effects of Drugs Antiparkinson Agents Enzyme Inhibitors Central Nervous System Stimulants Cholinergic Agents |
Protective Agents Neuroprotective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Monoamine Oxidase Inhibitors Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |