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Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Margaret Gibbons, Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00365508
First received: August 16, 2006
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Interventions: Drug: nicotine lozenge
Drug: nicotine patch

  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
Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1299 individuals were screened for this trial over 4 years; 454 individuals were ineligible, 194 refused enrollment, and 651 were randomized. Nine individuals either withdrew from the study prior to treatment or were found to be ineligible after randomization and were removed from the intent-to-treat sample. The final ITT sample was 642 (321/arm).

Reporting Groups
  Description
Nicotine Patch Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
Nicotine Lozenge Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

Participant Flow:   Overall Study
    Nicotine Patch     Nicotine Lozenge  
STARTED     321     321  
COMPLETED     182     167  
NOT COMPLETED     139     154  
Lost to Follow-up                 139                 154  



  Baseline Characteristics
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Reporting Groups
  Description
Arm I Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
Arm II Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
 		  321     321     642  
Age  
[units: years]
Mean ± Standard Deviation 		  44.7  ± 12.7     44.8  ± 11.9     44.7  ± 12.3  
Gender  
[units: participants]
 		     
Female     195     170     365  
Male     126     151     277  



  Outcome Measures
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1.  Primary:   24-hour Point Prevalence Abstinence at the 6-month Follow up   [ Time Frame: 6-months ]
  Show Outcome Measure 1

2.  Secondary:   Rate of Compliance During the First 2 Weeks   [ Time Frame: 2 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
The study was an effectiveness trial so external vs. internal validity was emphasized. Many participants were lost to follow-up.  


Results Point of Contact:  
Name/Title: Robert Schnoll
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu


No publications provided


Responsible Party: Margaret Gibbons, Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00365508     History of Changes
Other Study ID Numbers: CDR0000491296, FCCC-FCRB-04-003-P, 05-818
Study First Received: August 16, 2006
Results First Received: November 20, 2012
Last Updated: December 20, 2012
Health Authority: United States: Federal Government