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NCT01654107 Clinical Trial

Persistence-Targeted Smoking Cessation

Tobacco Use Disorder Clinical Trial

— PTSC  

Official title:
Persistence-Targeted Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01654107
Other study ID # 0220110199
Secondary ID R34DA030652
Status Completed
Phase Phase 1
First received July 19, 2012
Last updated August 17, 2015
Start date July 2012
Est. completion date September 2014

Study information
Verified date July 2015
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Persistence Targeted Smoking Cessation
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
• Clearing The Air
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Drug:
• Nicotine lozenge
12-weeks 4mg nicotine lozenge

Locations
Country Name City State
United States Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 7-day Point Prevalence Abstinence 3-months after the Quit Date 3-months No
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