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Persistence-Targeted Smoking Cessation (PTSC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01654107
First received: July 19, 2012
Last updated: November 3, 2014
Last verified: November 2014

July 19, 2012
November 3, 2014
July 2012
September 2014   (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
Not Provided
Not Provided
 
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
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Disorder
  • 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
    Other Name: nicotine lozenge
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
September 2014
September 2014   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT01654107
0220110199, R34DA030652
Yes
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marc L Steinberg, Ph.D. Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
November 2014

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