Persistence-Targeted Smoking Cessation (PTSC)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01654107
First received: July 19, 2012
Last updated: August 17, 2015
Last verified: July 2015
Results First Received: August 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Behavioral: Persistence Targeted Smoking Cessation
Behavioral: Clearing The Air
Drug: Nicotine lozenge

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Persistence Targeted Smoking Cessation

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

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

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing The Air

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

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

Nicotine lozenge: 12-weeks 4mg nicotine lozenge


Participant Flow:   Overall Study
    Persistence Targeted Smoking Cessation     Clearing The Air  
STARTED     28     30  
COMPLETED     25     22  
NOT COMPLETED     3     8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Persistence Targeted Smoking Cessation

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

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

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing The Air

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

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

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Total Total of all reporting groups

Baseline Measures
    Persistence Targeted Smoking Cessation     Clearing The Air     Total  
Number of Participants  
[units: participants]
  28     30     58  
Age  
[units: years]
Mean (Standard Deviation)
  47.82  (10.205)     48.93  (8.574)     48.40  (9.330)  
Gender  
[units: participants]
     
Female     17     16     33  
Male     11     14     25  



  Outcome Measures

1.  Primary:   7-day Point Prevalence Abstinence   [ Time Frame: 3-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marc L. Steinberg, Ph.D.
Organization: Rutgers Robert Wood Johnson Medical School
phone: 7322354341
e-mail: marc.steinberg@rutgers.edu



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01654107     History of Changes
Other Study ID Numbers: 0220110199
R34DA030652 ( US NIH Grant/Contract Award Number )
Study First Received: July 19, 2012
Results First Received: August 17, 2015
Last Updated: August 17, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board