Persistence-Targeted Smoking Cessation
PTSC
2 other identifiers
interventional
58
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedAugust 21, 2017
July 1, 2017
2.2 years
July 19, 2012
August 17, 2015
July 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day Point Prevalence Abstinence
3-months after the Quit Date
3-months
Study Arms (2)
Persistence Targeted Smoking Cessation
EXPERIMENTALPersistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge
Clearing The Air
ACTIVE COMPARATORClearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Interventions
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
12-weeks 4mg nicotine lozenge
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc L. Steinberg, Ph.D.
- Organization
- Rutgers Robert Wood Johnson Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Marc L Steinberg, Ph.D.
Rutgers, The State University of New Jersey
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 31, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
August 21, 2017
Results First Posted
September 16, 2015
Record last verified: 2017-07