Persistence-Targeted Smoking Cessation (PTSC)

July 13, 2017 updated by: Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Persistence Targeted Smoking Cessation
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Behavioral: Persistence Targeted Smoking Cessation
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Other Names:
  • PTSC
Drug: Nicotine lozenge
12-weeks 4mg nicotine lozenge
Active Comparator: Clearing The Air
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Drug: Nicotine lozenge
12-weeks 4mg nicotine lozenge
Behavioral: Clearing The Air
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Other Names:
  • CTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day Point Prevalence Abstinence
Time Frame: 3-months
3-months after the Quit Date
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Marc L Steinberg, Ph.D., Rutgers, the State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0220110199
  • R34DA030652 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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