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Sponsors and Collaborators: |
University of Connecticut Health Center National Center for Research Resources (NCRR) |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00755716 |
Specific aims:
Condition | Intervention | Phase |
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Tobacco Dependence |
Drug: Placebo Drug: topiramate Drug: topiramate plus nicotine patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study |
Estimated Enrollment: | 90 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
group 1: Placebo Comparator
Person receive an inactive placebo
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Drug: Placebo
patients receive
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2: Active Comparator
topiramate capsules
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Drug: topiramate
25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper
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3: Active Comparator
topiramate plus nicotine patch
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Drug: topiramate plus nicotine patch
subjects receive 10 weeks of topirmate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day for a total time of 10 weeks. On the quit date (after 2 weeks of medication use), subjects also use 21mg patch for 8 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contact: Enid Zayas | 860-679-3136 |
United States, Connecticut | |
University of Connecticut Halth Center | Recruiting |
Farmington, Connecticut, United States, 06030 | |
Principal Investigator: Cheryl Oncken, MD |
Principal Investigator: | Cheryl A Oncken, MD | University of Conneciticut Health Center |
Responsible Party: | University of Connecticut School of Medicine ( Cheryl Oncken, MD ) |
Study ID Numbers: | 06-114-1, 006192 |
Study First Received: | September 18, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755716 |
Health Authority: | United States: Institutional Review Board |
nicotine patch smoking topiramate |
Nicotine polacrilex Smoking Nicotine Mental Disorders |
Tobacco Use Disorder Substance-Related Disorders Topiramate Disorders of Environmental Origin |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Anti-Obesity Agents Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |