Maintaining Nonsmoking: Older Smokers - 1
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2004 | ||||
| Last Updated Date | January 30, 2013 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Biochemically verified abstinence from cigarettes. [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Smoking Behavior | ||||
| Change History | Complete list of historical versions of study NCT00086385 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Maintaining Nonsmoking: Older Smokers - 1 | ||||
| Official Title ICMJE | Maintaining Nonsmoking: Older Smokers | ||||
| Brief Summary | The purpose of this study is to examine pharmacological and psychological interventions for smokers over 50. |
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| Detailed Description | The overall goals of this line of research are to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study are to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression.Participants are 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Tobacco Use Disorder | ||||
| Intervention ICMJE | Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban |
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| Study Arm (s) |
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| Publications * | Hall SM, Humfleet GL, Muñoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. Epub 2009 Apr 9. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 403 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | smokers of at least 10 cigarettes per day Inclusion Criteria: MULTIPLE Exclusion Criteria: MULTIIPLE |
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00086385 | ||||
| Other Study ID Numbers ICMJE | NIDA-02538-1, R01DA002538, R01-02538-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sharon Hall, University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | January 2013 | ||||
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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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