Trial · NCT01314001
Pharmacogenetics of Nicotine Addiction Treatment
NCT01314001, Phase 3, Completed, University of Pennsylvania; results first posted 2016-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacogenetics of Nicotine Addiction Treatment. Trials, record NCT01314001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01314001
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacogenetics of Nicotine Addiction Treatment
- NCT number
- NCT01314001
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,246 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Nicotine Addiction
- Interventions
- Varenicline, Placebo, Transdermal Nicotine
- First posted
- 2011-03-14
- Last updated
- 2016-03-03
- Results first posted
- 2016-03-03
- Limitations and caveats
- A limitation is that few Hispanics or Asians were included.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Week 11 | The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers. |
| Secondary | 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Week 24 | The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers. |
| Secondary | Total Side-Effect Severity Index at Pre-Quit | Pre-Quit (Week -1/Baseline) | The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects. |
| Secondary | Total Side-Effect Severity Index at Target Quit Date | Target Quit Date (Week 0) | The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects. |
| Secondary | Total Side-Effect Severity Index at Week 1 | Week 1 | The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects. |
| Secondary | Total Side-Effect Severity Index at Week 4 | Week 4 | The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Week 11 | Intent-to-treat population (all subjects who received at least one dose of intervention). | percentage of ITT subjects | NUMBER |
| SECONDARY | 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Week 24 | Intent-to-treat population (all subjects who received at least one dose of intervention). | percentage of ITT subjects | NUMBER |
| SECONDARY | Total Side-Effect Severity Index at Pre-Quit | Pre-Quit (Week -1/Baseline) | Intent-to-treat population (all subjects who received at least one dose of intervention). | units on a scale | MEAN |
| SECONDARY | Total Side-Effect Severity Index at Target Quit Date | Target Quit Date (Week 0) | Intent-to-treat population (all subjects who received at least one dose of intervention). | units on a scale | MEAN |
| SECONDARY | Total Side-Effect Severity Index at Week 1 | Week 1 | Intent-to-treat population (all subjects who received at least one dose of intervention). | units on a scale | MEAN |
| SECONDARY | Total Side-Effect Severity Index at Week 4 | Week 4 | Intent-to-treat population (all subjects who received at least one dose of intervention). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Placebo (Slow Metabolizers) | 17.2 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Placebo (Normal Metabolizers) | 18.6 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Nicotine Patch (Slow Metabolizers) | 27.7 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Nicotine Patch (Normal Metabolizers) | 22.5 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Varenicline (Slow Metabolizers) | 30.4 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) | Varenicline (Normal Metabolizers) | 38.5 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Placebo (Slow Metabolizers) | 14.4 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Placebo (Normal Metabolizers) | 12.9 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Nicotine Patch (Slow Metabolizers) | 21.6 | percentage of ITT subjects | ||
| 7-day Point Prevalence Quit Rate at 6-month Follow up Survey | Nicotine Patch (Normal Metabolizers) | 13.6 | percentage of ITT subjects |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Slow Metabolizers) | 215 | |
| Overall Study | STARTED | Placebo (Normal Metabolizers) | 193 | |
| Overall Study | STARTED | Nicotine Patch (Slow Metabolizers) | 227 | |
| Overall Study | STARTED | Nicotine Patch (Normal Metabolizers) | 191 | |
| Overall Study | STARTED | Varenicline (Slow Metabolizers) | 220 | |
| Overall Study | STARTED | Varenicline (Normal Metabolizers) | 200 | |
| Overall Study | End-of-Treatment Visit | Placebo (Slow Metabolizers) | 156 | |
| Overall Study | End-of-Treatment Visit | Placebo (Normal Metabolizers) | 141 | |
| Overall Study | End-of-Treatment Visit | Nicotine Patch (Slow Metabolizers) | 179 | |
| Overall Study | End-of-Treatment Visit | Nicotine Patch (Normal Metabolizers) | 146 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events354
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 | Chest Pain | Cardiac disorders | Placebo (Slow Metabolizers) | 14 | 215 | |
| other | Chest Pain | Cardiac disorders | Placebo (Normal Metabolizers) | 12 | 193 | |
| other | Chest Pain | Cardiac disorders | Nicotine Patch (Slow Metabolizers) | 11 | 227 | |
| other | Chest Pain | Cardiac disorders | Nicotine Patch (Normal Metabolizers) | 7 | 191 | |
| other | Chest Pain | Cardiac disorders | Varenicline (Slow Metabolizers) | 13 | 220 | |
| other | Chest Pain | Cardiac disorders | Varenicline (Normal Metabolizers) | 7 | 200 | |
| other | Heart Palpitations | Cardiac disorders | Placebo (Slow Metabolizers) | 28 | 215 | |
| other | Heart Palpitations | Cardiac disorders | Placebo (Normal Metabolizers) | 22 | 193 | |
| other | Heart Palpitations | Cardiac disorders | Nicotine Patch (Slow Metabolizers) | 20 | 227 | |
| other | Heart Palpitations | Cardiac disorders | Nicotine Patch (Normal Metabolizers) | 15 | 191 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Slow Metabolizers) | ||
| Total, all-cause mortality | Placebo (Normal Metabolizers) | ||
| Total, all-cause mortality | Nicotine Patch (Slow Metabolizers) | ||
| Total, all-cause mortality | Nicotine Patch (Normal Metabolizers) | ||
| Total, all-cause mortality | Varenicline (Slow Metabolizers) | ||
| Total, all-cause mortality | Varenicline (Normal Metabolizers) | ||
| Total, other adverse events | Placebo (Slow Metabolizers) | 194 | 215 |
| Total, other adverse events | Placebo (Normal Metabolizers) | 171 | 193 |
| Total, other adverse events | Nicotine Patch (Slow Metabolizers) | 206 | 227 |
| Total, other adverse events | Nicotine Patch (Normal Metabolizers) | 169 | 191 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DA020830 | Pharmacogenetics of Nicotine Addiction Treatment | LERMAN, CARYN; TYNDALE, RACHEL FYNVOLA | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON DRUG ABUSE | 2005 to 2014 |
Source NIH RePORTER
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/NCT01314001
GET https://conductscience.org/api/trials/v1/NCT01314001/results?page=2