Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype (ConNic3)
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| Study Type: | Interventional |
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| 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
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| 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 |
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| 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
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 | |
|---|---|---|---|---|---|---|---|---|---|
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Number of Participants
[units: participants] |
132 | 109 | 112 | 114 | 34 | 36 | 35 | 34 | 606 |
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Age
[units: participants] |
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| <=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 |
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Gender
[units: participants] |
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| Female | 68 | 50 | 49 | 61 | 17 | 17 | 22 | 16 | 300 |
| Male | 64 | 59 | 63 | 53 | 17 | 19 | 13 | 18 | 306 |
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Region of Enrollment
[units: participants] |
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| United States | 132 | 109 | 112 | 114 | 34 | 36 | 35 | 34 | 606 |
Outcome Measures
| 1. Primary: | The Primary Outcome of the Study Will be 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: | In Addition to the Primary Outcome, Secondary Outcomes Will Include Point Abstinence (7 Days) at 6 Months, and Continuous Abstinence at 11 Weeks Post-quit and 6 Months. [ Time Frame: point abstinence (7 days) at 6 months post-quit date and continuous abstinence at 11 weeks post-quit ] |
More Information
| 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 |
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| 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. |
Results Point of Contact:
Organization: Duke University Medical Center
phone: 919-668-5055
e-mail: jed.rose@duke.edu
No publications provided
| 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: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |