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Completed

NCT Number: NCT01654107

Persistence-Targeted Smoking Cessation

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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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Persistence Targeted Smoking Cessation

Behavioral

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

Other names: PTSC

Clearing The Air

Behavioral

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

Other names: CTA

Nicotine Lozenge

Drug

12-weeks 4mg nicotine lozenge

Primary outcomes

  1. 7-day Point Prevalence Abstinence

    Time frame: 3-months

    3-months after the Quit Date

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: PTSC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2012
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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