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Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

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ClinicalTrials.gov Identifier: NCT00365508
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : January 30, 2013
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (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
Enrollment 642
Recruitment Details 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 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).
Arm/Group Title Nicotine Patch Nicotine Lozenge
Hide Arm/Group Description 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. 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).
Period Title: Overall Study
Started 321 321
Completed 182 167
Not Completed 139 154
Reason Not Completed
Lost to Follow-up             139             154
Arm/Group Title Arm I Arm II Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 321 321 642
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 321 participants 321 participants 642 participants
44.7  (12.7) 44.8  (11.9) 44.7  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 321 participants 642 participants
Female
195
  60.7%
170
  53.0%
365
  56.9%
Male
126
  39.3%
151
  47.0%
277
  43.1%
1.Primary Outcome
Title 24-hour Point Prevalence Abstinence at the 6-month Follow up
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis (lost to follow-up = smoker)
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
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.
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).
Overall Number of Participants Analyzed 321 321
Measure Type: Number
Unit of Measure: participants
50 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments a priori threshold for statistical significance
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Rate of Compliance During the First 2 Weeks
Hide Description Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
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.
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).
Overall Number of Participants Analyzed 321 321
Measure Type: Number
Unit of Measure: participants
231 87
Time Frame 6 months
Adverse Event Reporting Description Administered a checklist of side effects from NRT and collected any additional information on adverse events.
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description 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. 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).
All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/321 (1.25%)      7/321 (2.18%)    
Cardiac disorders     
Stroke *  2/321 (0.62%)  2 0/321 (0.00%)  0
Heart disease *  0/321 (0.00%)  0 1/321 (0.31%)  1
heart attack *  0/321 (0.00%)  0 1/321 (0.31%)  1
Gastrointestinal disorders     
ulcer *  0/321 (0.00%)  0 1/321 (0.31%)  1
appendicitis *  0/321 (0.00%)  0 1/321 (0.31%)  1
Injury, poisoning and procedural complications     
killed in car accident *  1/321 (0.31%)  1 0/321 (0.00%)  0
Nervous system disorders     
Seizure *  1/321 (0.31%)  1 1/321 (0.31%)  1
Respiratory, thoracic and mediastinal disorders     
cough *  0/321 (0.00%)  0 1/321 (0.31%)  1
Surgical and medical procedures     
Abcessed tooth *  0/321 (0.00%)  0 1/321 (0.31%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/321 (0.00%)      0/321 (0.00%)    
The study was an effectiveness trial so external vs. internal validity was emphasized. Many participants were lost to follow-up.
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: Robert Schnoll
Organization: University of Pennsylvania
Phone: 215-746-7143
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00365508     History of Changes
Other Study ID Numbers: CDR0000491296
FCCC-FCRB-04-003-P ( Other Identifier: Community Clinical Oncology Program Network )
05-818 ( Other Identifier: Fox Chase Cancer Center )
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: November 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: March 29, 2016