Persistence-Targeted Smoking Cessation (PTSC)

Tracking Information
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; (submitted: August 17, 2015)	7-day Point Prevalence Abstinence [ Time Frame: 3-months ]; 3-months after the Quit Date
Original Primary Outcome Measures ICMJE; (submitted: July 27, 2012)	Prolonged abstinence [ Time Frame: 3-months ]; 3-months after the Quit Date
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
Condition ICMJE	Tobacco Use Disorder
Intervention ICMJE	Behavioral: Persistence Targeted Smoking Cessation 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") Other Name: PTSC; Behavioral: Clearing The Air 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air Other Name: CTA; Drug: Nicotine lozenge 12-weeks 4mg nicotine lozenge
Study Arms	Experimental: Persistence Targeted Smoking Cessation Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge Interventions: Behavioral: Persistence Targeted Smoking Cessation Drug: Nicotine lozenge; Active Comparator: Clearing The Air Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge Interventions: Behavioral: Clearing The Air Drug: Nicotine lozenge
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; (submitted: November 3, 2014)	58
Original Estimated Enrollment ICMJE; (submitted: July 27, 2012)	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: Must be between 18 - 64 years old; Must smoke at least 10 cigarettes per day for past 6-months; Expired breath carbon monoxide (CO) > 7; Must have a working cellular phone Exclusion Criteria: Must not be currently receiving tobacco dependence treatment counseling; Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler); Must have no contraindications to using nicotine lozenge
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Principal Investigator: Marc L Steinberg, Ph.D. Rutgers, The State University of New Jersey
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