Trial · NCT00326781
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
NCT00326781, Phase 4, Completed, University of Pennsylvania; results first posted 2010-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT). Trials, record NCT00326781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00326781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
- NCT number
- NCT00326781
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 674 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Smoking
- Interventions
- Nicoderm Transdermal Patch, Nicotine Nasal Spray
- First posted
- 2006-05-17
- Last updated
- 2010-08-24
- Results first posted
- 2010-03-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | End of Treatment (8-weeks after quit date) | A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.). |
| Secondary | Verified 7-day Point Prevalence Abstinence at End Of Treatment. | End of Treatment | End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey. This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey. |
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 | Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | End of Treatment (8-weeks after quit date) | Analysis was intention to treat (ITT) | Participants | NUMBER |
| SECONDARY | Verified 7-day Point Prevalence Abstinence at End Of Treatment. | End of Treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | Transdermal Nicotine | 83 | Participants | ||
| Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | Nicotine Nasal Spray | 75 | Participants | ||
| Verified 7-day Point Prevalence Abstinence at End Of Treatment. | Transdermal Nicotine | 112 | participants | ||
| Verified 7-day Point Prevalence Abstinence at End Of Treatment. | Nicotine Nasal Spray | 95 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Transdermal Nicotine | 344 | |
| Overall Study | STARTED | Nicotine Nasal Spray | 330 | |
| Overall Study | COMPLETED | Transdermal Nicotine | 302 | |
| Overall Study | COMPLETED | Nicotine Nasal Spray | 298 | |
| Overall Study | NOT COMPLETED | Transdermal Nicotine | 42 | |
| Overall Study | NOT COMPLETED | Nicotine Nasal Spray | 32 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transdermal Nicotine | ||
| Total, all-cause mortality | Nicotine Nasal Spray | ||
| Total, other adverse events | Transdermal Nicotine | 0 | 344 |
| Total, other adverse events | Nicotine Nasal Spray | 0 | 330 |
| Total, serious adverse events | Transdermal Nicotine | 0 | 344 |
| Total, serious adverse events | Nicotine Nasal Spray | 0 | 330 |
Source ClinicalTrials.gov
Papers14
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 |
|---|---|---|---|---|---|
| P50CA084718 | Transdisciplinary Tobacco Use Research Centers | LERMAN, CARYN | UNIVERSITY OF PENNSYLVANIA | NATIONAL CANCER INSTITUTE | 1999 to 2008 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Transdermal Nicotine vs Nicotine Nasal Spray: Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | Trial comparisons |
| Transdermal Nicotine vs Nicotine Nasal Spray: Verified 7-day Point Prevalence Abstinence at End Of Treatment. | Trial comparisons |
| Transdermal Nicotine vs Nicotine Nasal Spray: serious adverse events | Trial comparisons |
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/NCT00326781
GET https://conductscience.org/api/trials/v1/NCT00326781/registered