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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00734617 |
The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent & 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.
Condition | Intervention | Phase |
---|---|---|
Cigarette Smoking |
Drug: Nicotine Patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
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Less Dependent Smokers: Experimental |
Drug: Nicotine Patch
Groups 1 & 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day Groups 2 & 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day |
More Dependent Smokers: Experimental |
Drug: Nicotine Patch
Groups 1 & 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day Groups 2 & 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Potential subjects who have abused alcohol or drugs, or have used within the last 30 days experimental (investigational) drugs, psychiatric medications (including antidepressants, anti-psychotics) or any other medications that are known to affect smoking cessation (e.g. clonidine) will be excluded. Potential subjects who have used smokeless tobacco (chewing tobacco, snuff), cigars, pipes, nicotine replacement therapy, or other smoking cessation treatment within the last 2 weeks will be excluded. Pregnant or nursing mothers will be excluded.
Use of non-opiate medications for pain or sleep will be allowed. For medical conditions that do not appear above, the study physician will be consulted and if the medical condition does not jeopardize safe study participation, then the subject may be enrolled.
Contact: Jed E Rose, Ph.D | 919-668-5055 | rose0003@mc.duke.edu |
Contact: Tanaia H Loeback | 919-668-5055 | loeba001@mc.duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Jed E Rose, Ph.D. | Duke University |
Responsible Party: | Duke Center for Nicotine & Smoking Cessation Research ( Jed E. Rose, Ph.D. ) |
Study ID Numbers: | 00001223 |
Study First Received: | August 13, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00734617 |
Health Authority: | United States: Institutional Review Board |
Cigarette Nicotine |
Nicotine polacrilex Smoking Nicotine |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Habits Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |