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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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


Reporting Groups
  Description
Less Dependent No text entered.
More Dependent No text entered.

Participant Flow:   Overall Study
    Less Dependent   More Dependent
STARTED   249   230 
COMPLETED   142   128 
NOT COMPLETED   107   102 
Adverse Event                4                7 
Withdrawal by Subject                103                95 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Less Dependent No text entered.
More Dependent No text entered.
Total Total of all reporting groups

Baseline Measures
   Less Dependent   More Dependent   Total 
Overall Participants Analyzed 
[Units: Participants]
 249   230   479 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   249   230   479 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.7  (11.4)   44.34  (10.92)   43.53  (11.12) 
Gender 
[Units: Participants]
     
Female   136   136   272 
Male   113   94   207 
Region of Enrollment 
[Units: Participants]
     
United States   249   230   479 


  Outcome Measures

1.  Primary:   Continuous Abstinence From Smoking at Ten Weeks Post-quit   [ Time Frame: May 2009 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Continuous Abstinence From Smoking at Ten Weeks Post-quit
Measure 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  

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.
No text entered.

Reporting Groups
  Description
Less Dependent No text entered.
More Dependent No text entered.

Measured Values
   Less Dependent   More Dependent 
Participants Analyzed   249   230 
Continuous Abstinence From Smoking at Ten Weeks Post-quit 
[Units: Participants]
   
21mg Nicotine Patch   31   21 
42mg Nicotine Patch   17   26 

No statistical analysis provided for Continuous Abstinence From Smoking at Ten Weeks Post-quit




  Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Less Dependent No text entered.
More Dependent No text entered.

Serious Adverse Events
    Less Dependent   More Dependent
Total, Serious Adverse Events     
# participants affected / at risk   0/249 (0.00%)   0/230 (0.00%) 




  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Less Dependent No text entered.
More Dependent No text entered.

Other Adverse Events
    Less Dependent   More Dependent
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/249 (0.00%)   0/230 (0.00%) 



  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
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  More Information

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
e-mail: rose0003@mc.duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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