Back to resultsPersistence-Targeted Smoking Cessation (PTSC)
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Persistence Targeted Smoking Cessation
Clearing The Air
Nicotine lozenge
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring tobacco, smoking cessation, nicotine dependence
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
Sites / Locations
- Rutgers Robert Wood Johnson Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Persistence Targeted Smoking Cessation
Clearing The Air
Arm Description
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Outcomes
Primary Outcome Measures
7-day Point Prevalence Abstinence
3-months after the Quit Date
Secondary Outcome Measures
Full Information
NCT ID
NCT01654107
First Posted
July 19, 2012
Last Updated
July 13, 2017
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01654107
Brief Title
Persistence-Targeted Smoking Cessation
Acronym
PTSC
Official Title
Persistence-Targeted Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
tobacco, smoking cessation, nicotine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persistence Targeted Smoking Cessation
Arm Type
Experimental
Arm Description
Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Arm Title
Clearing The Air
Arm Type
Active Comparator
Arm Description
Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Intervention Type
Behavioral
Intervention Name(s)
Persistence Targeted Smoking Cessation
Other Intervention Name(s)
PTSC
Intervention Description
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
Intervention Type
Behavioral
Intervention Name(s)
Clearing The Air
Other Intervention Name(s)
CTA
Intervention Description
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Intervention Type
Drug
Intervention Name(s)
Nicotine lozenge
Intervention Description
12-weeks 4mg nicotine lozenge
Primary Outcome Measure Information:
Title
7-day Point Prevalence Abstinence
Description
3-months after the Quit Date
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc L Steinberg, Ph.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Persistence-Targeted Smoking Cessation
We'll reach out to this number within 24 hrs