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Persistence-Targeted Smoking Cessation (PTSC)

This study is currently recruiting participants.
Verified July 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01654107
First received: July 19, 2012
Last updated: July 27, 2012
Last verified: July 2012
History of Changes

July 19, 2012
July 27, 2012
July 2012
September 2013   (final data collection date for primary outcome measure)
Prolonged abstinence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
3-months after the Quit Date
Same as current
Complete list of historical versions of study NCT01654107 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Persistence-Targeted Smoking Cessation
Persistence-Targeted Smoking Cessation

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).

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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Disorder
Behavioral: Smoking Cessation Counseling
8 weekly counseling sessions plus 12 weeks of nicotine lozenge
Experimental: Smoking Cessation Counseling
Eight weekly smoking cessation counseling sessions (plus nicotine lozenge)
Intervention: Behavioral: Smoking Cessation Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact: Marc L Steinberg, Ph.D. (732) 501-2650
United States
 
NCT01654107
R34DA030652
Yes
University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
Not Provided
Principal Investigator: Marc L Steinberg, Ph.D. University of Medicine and Dentistry New Jersey
University of Medicine and Dentistry New Jersey
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP