Persistence-Targeted Smoking Cessation

Study Overview
=================
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.

Official Title
-----------------
Persistence-Targeted Smoking Cessation

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Persistence Targeted Smoking Cessation
* Behavioral: Clearing The Air
* Drug: Nicotine lozenge


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco, smoking cessation, nicotine dependence