Trial · NCT00755716
Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
NCT00755716, Phase 3, Completed, UConn Health; results first posted 2017-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study. Trials, record NCT00755716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00755716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study
- NCT number
- NCT00755716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- UConn Health
- Conditions
- Tobacco Dependence
- Interventions
- Placebo (sugar pill), Topiramate, Nicotine patch
- First posted
- 2008-09-19
- Last updated
- 2017-08-16
- Results first posted
- 2017-08-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. | weeks 7-10 | The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment. |
| Secondary | MNWS | Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded. | Minnesota Nicotine Withdrawing Scale Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. | weeks 7-10 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | MNWS | Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded. | Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. | Placebo (Sugar Pill) | 1 | Participants | ||
| Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. | Topiramate | 5 | Participants | ||
| Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment. | Topiramate and Nicotine Patch | 7 | Participants | ||
| MNWS | Placebo (Sugar Pill) | 5.7 | Standard Error 1.3 | units on a scale | |
| MNWS | Topiramate | 4.9 | Standard Error 1.2 | units on a scale | |
| MNWS | Topiramate and Nicotine Patch | 6.8 | Standard Error 1.1 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Sugar Pill) | 19 | |
| Overall Study | STARTED | Topiramate | 19 | |
| Overall Study | STARTED | Topiramate and Nicotine Patch | 19 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill) | 11 | |
| Overall Study | COMPLETED | Topiramate | 11 | |
| Overall Study | COMPLETED | Topiramate and Nicotine Patch | 16 | |
| Overall Study | NOT COMPLETED | Placebo (Sugar Pill) | 8 | |
| Overall Study | NOT COMPLETED | Topiramate | 8 | |
| Overall Study | NOT COMPLETED | Topiramate and Nicotine Patch | 3 |
Source ClinicalTrials.gov
Adverse events54
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 | Paresthesia | Nervous system disorders | Placebo (Sugar Pill) | 0 | 19 | |
| other | Paresthesia | Nervous system disorders | Topiramate | 3 | 19 | |
| other | Paresthesia | Nervous system disorders | Topiramate & Nicotine Patch | 2 | 19 | |
| other | Fatigue | Psychiatric disorders | Placebo (Sugar Pill) | 1 | 19 | |
| other | Fatigue | Psychiatric disorders | Topiramate | 2 | 19 | |
| other | Fatigue | Psychiatric disorders | Topiramate & Nicotine Patch | 5 | 19 | |
| other | Loss Of Appetite | Gastrointestinal disorders | Placebo (Sugar Pill) | 0 | 19 | |
| other | Loss Of Appetite | Gastrointestinal disorders | Topiramate | 1 | 19 | |
| other | Loss Of Appetite | Gastrointestinal disorders | Topiramate & Nicotine Patch | 1 | 19 | |
| other | Difficulty with Memory | Psychiatric disorders | Placebo (Sugar Pill) | 0 | 19 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Sugar Pill) | 0 | 19 |
| Total, all-cause mortality | Topiramate | 0 | 19 |
| Total, all-cause mortality | Topiramate & Nicotine Patch | 0 | 19 |
| Total, other adverse events | Placebo (Sugar Pill) | 16 | 19 |
| Total, other adverse events | Topiramate | 17 | 19 |
| Total, other adverse events | Topiramate & Nicotine Patch | 18 | 19 |
| Total, serious adverse events | Placebo (Sugar Pill) | 0 | 19 |
| Total, serious adverse events | Topiramate | 0 | 19 |
| Total, serious adverse events | Topiramate & Nicotine Patch | 0 | 19 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| K24AA013736 | Novel Approaches to Alcoholism Pharmacotherapy and Risk | KRANZLER, HENRY RICHARD | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2002 to 2012 | NIH RePORTER |
| M01RR006192 | General Clinical Research Center | LAURENCIN, CATO T. | UNIVERSITY OF CONNECTICUT SCH OF MED/DNT | NATIONAL CENTER FOR RESEARCH RESOURCES | 1994 to 2008 | 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/NCT00755716
GET https://conductscience.org/api/trials/v1/NCT00755716/events?page=2