Persistence-Targeted Smoking Cessation

Phase 1

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Persistence Targeted Smoking Cessation; Behavioral: Clearing The Air; Drug: Nicotine lozenge

• Registration Number: NCT01654107
• Lead Sponsor: Rutgers, The State University of New Jersey

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-08-17
• Results First Submitted QC: 2015-08-17
• Results First Posted: 2015-09-16
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Persistence Targeted Smoking Cessation	Persistence Targeted Smoking Cessation	Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Persistence Targeted Smoking Cessation	Nicotine lozenge	Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air	Clearing The Air	Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air	Nicotine lozenge	Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Primary Outcome Measures

Name	Time	Method
7-day Point Prevalence Abstinence	3-months	3-months after the Quit Date

Trial Locations

Locations (1)

Rutgers Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States