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Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II (CON NIC II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00734617
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : March 1, 2011
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Cigarette Smoking
Intervention Drug: Nicotine Patch
Enrollment 479
Recruitment Details Recruitment start date: 8/20/2007 Recruitment end date: 3/19/2008 Recruitment locations: Duke Center for Nicotine & Smoking Cessation Research offices located in Charlotte, Durham, Raleigh and Winston-Salem NC.
Pre-assignment Details

Participants were excluded for the following reasons:

DID NOT MEET INCLUSION CRITERIA: 78 MET EXCLUSION CRITERIA: 74 UNABLE TO MEET STUDY REQUIREMENTS: 9 REFUSED TO PARTICIPATE: 18 LOST TO CONTACT (PRIOR TO V1): 30 LAB RESULTS: 64 MD/PA REFUSAL: 179 30 DAYS PAST PHYSICAL SCREENING: 1

Arm/Group Title Less Dependent More Dependent
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 249 230
Completed 142 128
Not Completed 107 102
Reason Not Completed
Adverse Event             4             7
Withdrawal by Subject             103             95
Arm/Group Title Less Dependent More Dependent Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 249 230 479
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 230 participants 479 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
249
 100.0%
230
 100.0%
479
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 249 participants 230 participants 479 participants
42.7  (11.4) 44.34  (10.92) 43.53  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 230 participants 479 participants
Female
136
  54.6%
136
  59.1%
272
  56.8%
Male
113
  45.4%
94
  40.9%
207
  43.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 249 participants 230 participants 479 participants
249 230 479
1.Primary Outcome
Title Continuous Abstinence From Smoking at Ten Weeks Post-quit
Hide Description Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.
Time Frame May 2009
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Less Dependent More Dependent
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 249 230
Measure Type: Number
Unit of Measure: participants
21mg Nicotine Patch 31 21
42mg Nicotine Patch 17 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Less Dependent More Dependent
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Less Dependent More Dependent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Less Dependent More Dependent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/249 (0.00%)   0/230 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Less Dependent More Dependent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/249 (0.00%)   0/230 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jed E. Rose, Ph.D.
Organization: Duke Center for Nicotine & Smoking Cessation Research
Phone: 919 668-5093
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734617     History of Changes
Other Study ID Numbers: Pro00001223
First Submitted: August 13, 2008
First Posted: August 14, 2008
Results First Submitted: February 3, 2011
Results First Posted: March 1, 2011
Last Update Posted: July 15, 2014