Persistence-Targeted Smoking Cessation (PTSC)
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ClinicalTrials.gov Identifier: NCT01654107 |
Recruitment Status
:
Completed
First Posted
: July 31, 2012
Results First Posted
: September 16, 2015
Last Update Posted
: August 21, 2017
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Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
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Tracking Information | ||||
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First Submitted Date ICMJE | July 19, 2012 | |||
First Posted Date ICMJE | July 31, 2012 | |||
Results First Submitted Date | August 17, 2015 | |||
Results First Posted Date | September 16, 2015 | |||
Last Update Posted Date | August 21, 2017 | |||
Study Start Date ICMJE | July 2012 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
7-day Point Prevalence Abstinence [ Time Frame: 3-months ] 3-months after the Quit Date
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Original Primary Outcome Measures ICMJE |
Prolonged abstinence [ Time Frame: 3-months ] 3-months after the Quit Date
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Change History | Complete list of historical versions of study NCT01654107 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 | Persistence-Targeted Smoking Cessation | |||
Official Title ICMJE | Persistence-Targeted Smoking Cessation | |||
Brief Summary | The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). | |||
Detailed Description | In this Stage I Behavioral & Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Tobacco Use Disorder | |||
Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
58 | |||
Original Estimated Enrollment ICMJE |
10 | |||
Actual Study Completion Date | September 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers | 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 | NCT01654107 | |||
Other Study ID Numbers ICMJE | 0220110199 R34DA030652 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey | |||
Study Sponsor ICMJE | Rutgers, The State University of New Jersey | |||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | |||
Investigators ICMJE |
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PRS Account | Rutgers, The State University of New Jersey | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |