Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype (ConNic3)

This study has been completed.
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00894166
First received: May 4, 2009
Last updated: September 19, 2013
Last verified: September 2013
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: Nicotine Patches
Drug: Nicotine patches, then bupropion & nicotine patches (Pre-Quit)
Drug: Nicotine patches, then varenicline (Pre-Quit)
Drug: Nicotine patches, then nicotine patches (Pre-Quit)
Drug: Nicotine patches, then bupropion & nicotine patches (Post-Quit)
Drug: Nicotine patches, then varenicline (Post-Quit)
Drug: Nicotine patches, then nicotine patches (Post-Quit)

  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
Study started June 2009 and ended April 2011 and was conducted at Duke University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrollees began nicotine patches & those who didn’t show a >50% reduction in expired air carbon monoxide (CO) at 1 week (1 week before the target quit date) or who lapsed in the 1st week after their quit date were randomized to one of 6 groups. The 7th group - Nicotine Replacement Therapy (NRT) Responders were excluded from this randomization.

Reporting Groups
  Description
NRT Responder

Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.

21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.

Pre-Quit Randomization to Bupropion + NRT

Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.

21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.

Pre-Quit Randomization to Varenicline

Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.

21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).

Pre-Quit Randomization to NRT

Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.

21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.

Post-Quit Randomization to Bupropion + NRT

Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.

21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.

Post-Quit Randomized to Varenicline

Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.

21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks).

Post-Quit Randomized to NRT

Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.

21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.

Withdrew Prior to Randomization

These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.

21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed.


Participant Flow:   Overall Study
    NRT Responder     Pre-Quit Randomization to Bupropion + NRT     Pre-Quit Randomization to Varenicline     Pre-Quit Randomization to NRT     Post-Quit Randomization to Bupropion + NRT     Post-Quit Randomized to Varenicline     Post-Quit Randomized to NRT     Withdrew Prior to Randomization  
STARTED     132     109     112     114     34     36     35     34  
COMPLETED     71     46     50     45     10     20     19     0  
NOT COMPLETED     61     63     62     69     24     16     16     34  
Withdrew or Lost to Follow-Up                 61                 63                 62                 68                 24                 16                 16                 34  
Death                 0                 0                 0                 1                 0                 0                 0                 0  



  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.
No text entered.

Reporting Groups
  Description
NRT Responder Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
Pre-Quit Randomization to Bupropion + NRT Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
Pre-Quit Randomization to Varenicline Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
Pre-Quit Randomization to NRT Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
Post-Quit Randomization to Bupropion + NRT Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
Post-Quit Randomized to Varenicline Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
Post-Quit Randomized to NRT Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
Withdrew Prior to Randomization These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
Total Total of all reporting groups

Baseline Measures
    NRT Responder     Pre-Quit Randomization to Bupropion + NRT     Pre-Quit Randomization to Varenicline     Pre-Quit Randomization to NRT     Post-Quit Randomization to Bupropion + NRT     Post-Quit Randomized to Varenicline     Post-Quit Randomized to NRT     Withdrew Prior to Randomization     Total  
Number of Participants  
[units: participants]
  132     109     112     114     34     36     35     34     606  
Age  
[units: participants]
                 
<=18 years     0     0     0     0     0     0     0     0     0  
Between 18 and 65 years     129     108     112     113     34     36     35     34     601  
>=65 years     3     1     0     1     0     0     0     0     5  
Age  
[units: years]
Mean ± Standard Deviation
  43.6  ± 10.2     46.0  ± 10.8     44.7  ± 10.7     44.3  ± 10.8     43.1  ± 11.6     44.1  ± 11.2     40.8  ± 12.8     40.7  ± 10.1     44.3  ± 10.8  
Gender  
[units: participants]
                 
Female     68     50     49     61     17     17     22     16     300  
Male     64     59     63     53     17     19     13     18     306  
Region of Enrollment  
[units: participants]
                 
United States     132     109     112     114     34     36     35     34     606  



  Outcome Measures
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1.  Primary:   Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)   [ Time Frame: weeks 8-11 after quit date ]

2.  Secondary:   Abstinence (7 Days) at 6 Months.   [ Time Frame: point abstinence (7 days) at 6 months post-quit date ]

3.  Secondary:   Continuous Abstinence From Smoking at 6 Months Post Quit.   [ Time Frame: continuous abstinence at 6 months post quit day ]


  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
The group sizes for the post quit date randomization groups was relatively small. Second, the study used a tailored dose of pre-cessation nicotine patch therapy that is not in accordance with current product labeling in the US.


  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: Jed E. Rose, Ph.D.
Organization: Duke University Medical Center
phone: 919-668-5055
e-mail: jed.rose@duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00894166     History of Changes
Other Study ID Numbers: Pro00013846
Study First Received: May 4, 2009
Results First Received: October 19, 2012
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board