Trial · NCT00894166
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
NCT00894166, Phase 3, Completed, Duke University; results first posted 2012-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype. Trials, record NCT00894166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00894166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
- NCT number
- NCT00894166
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 606 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Smoking Cessation
- Interventions
Nicotine Patches, Nicotine patches, then bupropion & nicotine patches (Pre-Quit), Nicotine patches, then varenicline (Pre-Quit), Nicotine patches, then nicotine patches (Pre-Quit), Nicotine patches, then bupropion & nicotine patches (Post-Quit), Nicotine patches, then varenicline (Post-Quit), Nicotine patches, then nicotine patches (Post-Quit)
- First posted
- 2009-05-06
- Last updated
- 2013-09-23
- Results first posted
- 2012-12-26
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | weeks 8-11 after quit date | A self report of no cigarettes smoked confirmed by expired air carbon monoxide of \<=10ppm was the criterion for abstinence. |
| Secondary | Abstinence (7 Days) at 6 Months. | point abstinence (7 days) at 6 months post-quit date | |
| Secondary | Continuous Abstinence From Smoking at 6 Months Post Quit. | continuous abstinence at 6 months post quit day |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | weeks 8-11 after quit date | All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment. | percentage of subjects abstinent | NUMBER |
| SECONDARY | Abstinence (7 Days) at 6 Months. | point abstinence (7 days) at 6 months post-quit date | percentage of subjects | NUMBER | |
| SECONDARY | Continuous Abstinence From Smoking at 6 Months Post Quit. | continuous abstinence at 6 months post quit day | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | NRT Responder | 59.2 | 95% Confidence Interval 50.4 to 68 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Pre-Quit Randomization to Bupropion + NRT | 28.3 | 95% Confidence Interval 19.4 to 37.2 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Pre-Quit Randomization to Varenicline | 23.3 | 95% Confidence Interval 15.1 to 31.5 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Pre-Quit Randomization to NRT | 16.0 | 95% Confidence Interval 9 to 23 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Post-Quit Randomization to Bupropion + NRT | 26.7 | 95% Confidence Interval 10.9 to 42.5 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Post-Quit Randomized to Varenicline | 37.1 | 95% Confidence Interval 21.1 to 53.1 | percentage of subjects abstinent | |
| Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) | Post-Quit Randomized to NRT | 26.7 | 95% Confidence Interval 10.9 to 42.5 | percentage of subjects abstinent | |
| Abstinence (7 Days) at 6 Months. | NRT Responder | 21.7 | percentage of subjects | ||
| Abstinence (7 Days) at 6 Months. | Pre-Quit Randomization to Bupropion + NRT | 17.2 | percentage of subjects | ||
| Abstinence (7 Days) at 6 Months. | Pre-Quit Randomization to Varenicline | 16.5 | percentage of subjects |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NRT Responder | 132 | |
| Overall Study | STARTED | Pre-Quit Randomization to Bupropion + NRT | 109 | |
| Overall Study | STARTED | Pre-Quit Randomization to Varenicline | 112 | |
| Overall Study | STARTED | Pre-Quit Randomization to NRT | 114 | |
| Overall Study | STARTED | Post-Quit Randomization to Bupropion + NRT | 34 | |
| Overall Study | STARTED | Post-Quit Randomized to Varenicline | 36 | |
| Overall Study | STARTED | Post-Quit Randomized to NRT | 35 | |
| Overall Study | STARTED | Withdrew Prior to Randomization | 34 | |
| Overall Study | COMPLETED | NRT Responder | 71 | |
| Overall Study | COMPLETED | Pre-Quit Randomization to Bupropion + NRT | 46 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HEADACHE | Nervous system disorders | NRT Responder | 18 | 132 | 23 |
| other | HEADACHE | Nervous system disorders | Pre-Quit Randomization to Bupropion + NRT | 17 | 109 | 21 |
| other | HEADACHE | Nervous system disorders | Pre-Quit Randomization to Varenicline | 9 | 112 | 9 |
| other | HEADACHE | Nervous system disorders | Pre-Quit Randomization to NRT | 17 | 114 | 22 |
| other | HEADACHE | Nervous system disorders | Post-Quit Randomization to Bupropion + NRT | 5 | 34 | 11 |
| other | HEADACHE | Nervous system disorders | Post-Quit Randomized to Varenicline | 6 | 36 | 7 |
| other | HEADACHE | Nervous system disorders | Post-Quit Randomized to NRT | 4 | 35 | 11 |
| other | EXCESSIVE SWEATING | General disorders | NRT Responder | 7 | 132 | 8 |
| other | EXCESSIVE SWEATING | General disorders | Pre-Quit Randomization to Bupropion + NRT | 12 | 109 | 21 |
| other | EXCESSIVE SWEATING | General disorders | Pre-Quit Randomization to Varenicline | 4 | 112 | 5 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NRT Responder | ||
| Total, all-cause mortality | Pre-Quit Randomization to Bupropion + NRT | ||
| Total, all-cause mortality | Pre-Quit Randomization to Varenicline | ||
| Total, all-cause mortality | Pre-Quit Randomization to NRT | ||
| Total, all-cause mortality | Post-Quit Randomization to Bupropion + NRT | ||
| Total, all-cause mortality | Post-Quit Randomized to Varenicline | ||
| Total, all-cause mortality | Post-Quit Randomized to NRT | ||
| Total, other adverse events | NRT Responder | 88 | 132 |
| Total, other adverse events | Pre-Quit Randomization to Bupropion + NRT | 74 | 109 |
| Total, other adverse events | Pre-Quit Randomization to Varenicline | 64 | 112 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00894166
GET https://conductscience.org/api/trials/v1/NCT00894166/results?page=2