Persistence-Targeted Smoking Cessation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Persistence Targeted Smoking Cessation

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

Group Type EXPERIMENTAL

Persistence Targeted Smoking Cessation

Intervention Type BEHAVIORAL

8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Nicotine lozenge

Intervention Type DRUG

12-weeks 4mg nicotine lozenge

Clearing The Air

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

Group Type ACTIVE_COMPARATOR

Clearing The Air

Intervention Type BEHAVIORAL

8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Nicotine lozenge

Intervention Type DRUG

12-weeks 4mg nicotine lozenge

Interventions

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Persistence Targeted Smoking Cessation

8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Intervention Type BEHAVIORAL

Clearing The Air

8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Intervention Type BEHAVIORAL

Nicotine lozenge

12-weeks 4mg nicotine lozenge

Intervention Type DRUG

Other Intervention Names

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PTSC CTA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes