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NCT00734617 · ClinicalTrials.gov registry record · Phase 3
Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
A Phase 3 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
NCT00734617 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 479 participants.
The verdict
NCT00734617, a Phase 3 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Nicotine Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734617
The ClinicalTrials.gov registry entry for NCT00734617 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nicotine Patch is the first listed.
NCT00734617 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00734617 about?
NCT00734617 is a clinical study titled "Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II". 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-cess...
What is the current status of trial NCT00734617?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2007-08. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00734617?
The interventions under investigation include: Nicotine Patch (DRUG).
Who is sponsoring clinical trial NCT00734617?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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