Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Public ClinicalTrials.gov record NCT00364156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.
Study identification
- NCT ID
- NCT00364156
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 568 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2004
- Primary completion
- Mar 31, 2008
- Completion
- Apr 30, 2008
- Last update posted
- Feb 27, 2018
2004 – 2008
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tobacco Use Research Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00364156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2018 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00364156 live on ClinicalTrials.gov.