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Persistence-Targeted Smoking Cessation (PTSC)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01654107
First received: July 19, 2012
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
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).

Condition Intervention Phase
Tobacco Use Disorder Behavioral: Persistence Targeted Smoking Cessation Behavioral: Clearing The Air Drug: Nicotine lozenge Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Persistence-Targeted Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 7-day Point Prevalence Abstinence [ Time Frame: 3-months ]
    3-months after the Quit Date


Enrollment: 58
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Persistence Targeted Smoking Cessation
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Behavioral: Persistence Targeted Smoking Cessation
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Other Name: PTSC
Drug: Nicotine lozenge
12-weeks 4mg nicotine lozenge
Active Comparator: Clearing The Air
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Behavioral: Clearing The Air
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Other Name: CTA
Drug: Nicotine lozenge
12-weeks 4mg nicotine lozenge

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.
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654107

Locations
United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marc L Steinberg, Ph.D. Rutgers, The State University of New Jersey
  More Information

Responsible Party: Marc L. Steinberg, Ph.D., Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01654107     History of Changes
Other Study ID Numbers: 0220110199
R34DA030652 ( U.S. NIH Grant/Contract )
Study First Received: July 19, 2012
Results First Received: August 17, 2015
Last Updated: July 13, 2017

Keywords provided by Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey:
tobacco
smoking cessation
nicotine dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 20, 2017