Trial · NCT01807871
Treatment of Smoking Lapses and Relapses
NCT01807871, Phase 4, Completed, University of Vermont; results first posted 2017-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Smoking Lapses and Relapses. Trials, record NCT01807871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01807871
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Smoking Lapses and Relapses
- NCT number
- NCT01807871
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 701 participants, actual
- Lead sponsor
- University of Vermont
- Conditions
- Smoking Cessation
- Interventions
- nicotine patch, experimental use, nicotine patch, labeled use
- First posted
- 2013-03-08
- Last updated
- 2017-10-13
- Results first posted
- 2017-03-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Point-prevalent Abstinence at 4 Months | 4 months after the quit date | To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No". |
| Secondary | Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence | 4 months after the quit date | To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence. |
| Secondary | Adverse Drug Effects | Up to 12 weeks | To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal. |
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 | Point-prevalent Abstinence at 4 Months | 4 months after the quit date | Participants who lapsed while using the nicotine patch | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence | 4 months after the quit date | Because the results for the primary outcome were negative, this outcome was not analyzed (i.e., there was no effect to mediate). | ||
| SECONDARY | Adverse Drug Effects | Up to 12 weeks | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Point-prevalent Abstinence at 4 Months | Nicotine Patch, Experimental Use | 90 | Participants | ||
| Point-prevalent Abstinence at 4 Months | Nicotine Patch, Labeled Use | 59 | Participants | ||
| Adverse Drug Effects | Nicotine Patch, Experimental Use | 37 | Participants | ||
| Adverse Drug Effects | Nicotine Patch, Labeled Use | 27 | 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, Experimental Use | 356 | |
| Overall Study | STARTED | Nicotine Patch, Labeled Use | 345 | |
| Overall Study | COMPLETED | Nicotine Patch, Experimental Use | 178 | |
| Overall Study | COMPLETED | Nicotine Patch, Labeled Use | 127 | |
| Overall Study | NOT COMPLETED | Nicotine Patch, Experimental Use | 178 | |
| Overall Study | NOT COMPLETED | Nicotine Patch, Labeled Use | 218 |
Source ClinicalTrials.gov
Adverse events20
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 | Insomnia | Psychiatric disorders | Nicotine Patch, Experimental Use | 79 | 356 | |
| other | Insomnia | Psychiatric disorders | Nicotine Patch, Labeled Use | 78 | 345 | |
| other | Skin irritation | Skin and subcutaneous tissue disorders | Nicotine Patch, Experimental Use | 122 | 356 | |
| other | Skin irritation | Skin and subcutaneous tissue disorders | Nicotine Patch, Labeled Use | 120 | 345 | |
| other | Dizziness | Nervous system disorders | Nicotine Patch, Experimental Use | 33 | 356 | |
| other | Dizziness | Nervous system disorders | Nicotine Patch, Labeled Use | 31 | 345 | |
| other | Headache | Nervous system disorders | Nicotine Patch, Experimental Use | 44 | 356 | |
| other | Headache | Nervous system disorders | Nicotine Patch, Labeled Use | 37 | 345 | |
| other | Nausea | Gastrointestinal disorders | Nicotine Patch, Experimental Use | 35 | 356 | |
| other | Nausea | Gastrointestinal disorders | Nicotine Patch, Labeled Use | 30 | 345 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicotine Patch, Experimental Use | 1 | 356 |
| Total, all-cause mortality | Nicotine Patch, Labeled Use | 1 | 345 |
| Total, other adverse events | Nicotine Patch, Experimental Use | 196 | 356 |
| Total, other adverse events | Nicotine Patch, Labeled Use | 187 | 345 |
| Total, serious adverse events | Nicotine Patch, Experimental Use | 4 | 356 |
| Total, serious adverse events | Nicotine Patch, Labeled Use | 4 | 345 |
Source ClinicalTrials.gov
Papers10
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 |
|---|---|---|---|---|---|
| R01CA165080 | Treatment of smoking lapses and relapses | HUGHES, JOHN R | UNIVERSITY OF VERMONT & ST AGRIC COLLEGE | NATIONAL CANCER INSTITUTE | 2012 to 2014 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nicotine Patch, Experimental Use vs Nicotine Patch, Labeled Use: Point-prevalent Abstinence at 4 Months | Trial comparisons |
| Nicotine Patch, Experimental Use vs Nicotine Patch, Labeled Use: Adverse Drug Effects | Trial comparisons |
| Nicotine Patch, Experimental Use vs Nicotine Patch, Labeled Use: deaths from any cause | Trial comparisons |
| Nicotine Patch, Experimental Use vs Nicotine Patch, Labeled Use: 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/NCT01807871
GET https://conductscience.org/api/trials/v1/NCT01807871/registered