Persistence-Targeted Smoking Cessation (PTSC)

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 1

Conditions: Tobacco Use Disorder

Treatments: Behavioral: Persistence Targeted Smoking Cessation; Behavioral: Clearing The Air; Drug: Nicotine lozenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01654107

R34DA030652 (U.S. NIH Grant/Contract)

0220110199

Details and patient eligibility

About

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).

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Persistence Targeted Smoking Cessation

Experimental group

Description:

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

Treatment:

Drug: Nicotine lozenge

Behavioral: Persistence Targeted Smoking Cessation

Clearing The Air

Active Comparator group

Description:

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Treatment:

Drug: Nicotine lozenge

Behavioral: Clearing The Air