ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- At least 18 years of age
- Must be smoking 5 or more cigarettes per day
- Previous history of bipolar/manic-depressive disorder
- Current diagnosis of schizophrenia
- Acute life threatening diseases
- Evidence of alcohol or other drug abuse so severe that the patient is judged to be
potentially unable to comply with the protocol
- Pregnancy or lactation
- Individuals with out of normal range blood pressure, active angina, valve disease,
valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery
bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
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Descriptive Information | |||||||
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Brief Title ICMJE | Maintaining Nonsmoking | ||||||
Official Title ICMJE | Maintaining Nonsmoking | ||||||
Brief Summary | The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting. | ||||||
Detailed Description | This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment. All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Nicotine Dependence | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 216 | ||||||
Original Estimated Enrollment ICMJE | 360 | ||||||
Actual Study Completion Date ICMJE | June 2016 | ||||||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01162239 | ||||||
Other Study ID Numbers ICMJE | DA002538 2R01DA002538 ( U.S. NIH Grant/Contract ) 11633 ( Other Identifier: University of California, San Francisco ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of California, San Francisco | ||||||
Study Sponsor ICMJE | University of California, San Francisco | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, San Francisco | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |