Trial · NCT00365508
Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
NCT00365508, Phase 4, Completed, Fox Chase Cancer Center; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking. Trials, record NCT00365508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
- NCT number
- NCT00365508
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 642 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
- Interventions
- nicotine lozenge, nicotine patch
- First posted
- 2006-08-17
- Last updated
- 2016-03-29
- Results first posted
- 2013-01-30
- Limitations and caveats
- The study was an effectiveness trial so external vs. internal validity was emphasized. Many participants were lost to follow-up.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 24-hour Point Prevalence Abstinence at the 6-month Follow up | 6-months | |
| Secondary | Rate of Compliance During the First 2 Weeks | 2 weeks | Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence |
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 | 24-hour Point Prevalence Abstinence at the 6-month Follow up | 6-months | Intent to treat analysis (lost to follow-up = smoker) | participants | NUMBER |
| SECONDARY | Rate of Compliance During the First 2 Weeks | 2 weeks | Intent to treat | 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 |
|---|---|---|---|---|---|
| 24-hour Point Prevalence Abstinence at the 6-month Follow up | Arm I | 50 | participants | ||
| 24-hour Point Prevalence Abstinence at the 6-month Follow up | Arm II | 35 | participants | ||
| Rate of Compliance During the First 2 Weeks | Arm I | 231 | participants | ||
| Rate of Compliance During the First 2 Weeks | Arm II | 87 | 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 | Nicotine Patch | 321 | |
| Overall Study | STARTED | Nicotine Lozenge | 321 | |
| Overall Study | COMPLETED | Nicotine Patch | 182 | |
| Overall Study | COMPLETED | Nicotine Lozenge | 167 | |
| Overall Study | NOT COMPLETED | Nicotine Patch | 139 | |
| Overall Study | NOT COMPLETED | Nicotine Lozenge | 154 |
Source ClinicalTrials.gov
Adverse events18
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 |
|---|---|---|---|---|---|---|
| serious | Stroke | Cardiac disorders | Arm I | 2 | 321 | 2 |
| serious | Stroke | Cardiac disorders | Arm II | 0 | 321 | 0 |
| serious | Seizure | Nervous system disorders | Arm I | 1 | 321 | 1 |
| serious | Seizure | Nervous system disorders | Arm II | 1 | 321 | 1 |
| serious | killed in car accident | Injury, poisoning and procedural complications | Arm I | 1 | 321 | 1 |
| serious | killed in car accident | Injury, poisoning and procedural complications | Arm II | 0 | 321 | 0 |
| serious | Heart disease | Cardiac disorders | Arm I | 0 | 321 | 0 |
| serious | Heart disease | Cardiac disorders | Arm II | 1 | 321 | 1 |
| serious | ulcer | Gastrointestinal disorders | Arm I | 0 | 321 | 0 |
| serious | ulcer | Gastrointestinal disorders | Arm II | 1 | 321 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, all-cause mortality | Arm II | ||
| Total, other adverse events | Arm I | 0 | 321 |
| Total, other adverse events | Arm II | 0 | 321 |
| Total, serious adverse events | Arm I | 4 | 321 |
| Total, serious adverse events | Arm II | 7 | 321 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39868569 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I vs Arm II: 24-hour Point Prevalence Abstinence at the 6-month Follow up | Trial comparisons |
| Arm I vs Arm II: Rate of Compliance During the First 2 Weeks | Trial comparisons |
| Arm I vs Arm II: 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/NCT00365508
GET https://conductscience.org/api/trials/v1/NCT00365508/registered