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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 3, 2001 |
| Last Updated Date | January 20, 2009 |
| Start Date ICMJE | April 1998 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00018148 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation |
| Official Title ICMJE | Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation |
| Brief Summary | Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Smoking |
| Intervention ICMJE | Drug: nortriptyline |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | March 2001 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | 18 Years to 70 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00018148 |
| Responsible Party | |
| Study ID Numbers ICMJE | ADRD-006-97F |
| Study Sponsor ICMJE | Department of Veterans Affairs |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | December 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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