Persistence-Targeted Smoking Cessation (PTSC)

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

November 3, 2014

Start Date ^ICMJE

July 2012

Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prolonged abstinence [ Time Frame: 3-months ] [ Designated as safety issue: No ]

3-months after the Quit Date

Original Primary Outcome Measures ^ICMJE

Same as current

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Other Name: nicotine lozenge

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

September 2014

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

Gender

Both

Ages

18 Years to 64 Years

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

Has Data Monitoring Committee

Yes

Responsible Party

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

Information Provided By

Rutgers, The State University of New Jersey

Verification Date

November 2014

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

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