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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
  Purpose

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).


Condition Intervention Phase
Tobacco Use Disorder
 Behavioral: Smoking Cessation Counseling
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Persistence-Targeted Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Prolonged abstinence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    3-months after the Quit Date


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoking Cessation Counseling
Eight weekly smoking cessation counseling sessions (plus nicotine lozenge)
 Behavioral: Smoking Cessation Counseling
8 weekly counseling sessions plus 12 weeks of nicotine lozenge

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654107

Contacts
Contact: Marc L Steinberg, Ph.D. (732) 501-2650

Locations
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Marc L Steinberg, Ph.D.     732-501-2650        
Principal Investigator: Marc L Steinberg, Ph.D.            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Marc L Steinberg, Ph.D. University of Medicine and Dentistry New Jersey
  More Information

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01654107     History of Changes
Other Study ID Numbers: R34DA030652
Study First Received: July 19, 2012
Last Updated: July 27, 2012
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
tobacco
smoking cessation
nicotine dependence

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013