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| Sponsor: | University of Connecticut Health Center |
|---|---|
| Collaborator: |
National Center for Research Resources (NCRR) |
| Information provided by: | University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00755716 |
Purpose
Specific aims:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Enrollment: | 84 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (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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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Halth Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Cheryl A Oncken, MD | University of Conneciticut Health Center |
More Information
| 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: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00755716 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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nicotine patch smoking topiramate |
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Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Tobacco Use Disorder Nicotinic Agonists Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Stimulants Cholinergic Agents Protective Agents Neuroprotective Agents |
Pharmacologic Actions Anti-Obesity Agents Mental Disorders Nicotine Autonomic Agents Therapeutic Uses Substance-Related Disorders Ganglionic Stimulants Topiramate Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |