Trial · NCT03262662
EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
NCT03262662, Phase 3, Completed, State University of New York at Buffalo; results first posted 2023-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking. Trials, record NCT03262662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03262662
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
- NCT number
- NCT03262662
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 320 participants, actual
- Lead sponsor
- State University of New York at Buffalo
- Conditions
- Tobacco Smoking
- Interventions
- Varenicline, Brief smoking cessation counseling
- First posted
- 2017-08-25
- Last updated
- 2025-09-26
- Results first posted
- 2023-07-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification | Self-report Treatment Weeks 12-15; bio-verification ~Week 16 | Number of participants with bio-verified (cotinine level of 15 ng/mL or less) self-reported continuous abstinence from smoking (not even a puff) during the final four weeks of treatment |
| Secondary | Pre-quit Change in Cigarettes Smoked Per Day | Treatment Week 1 vs. Treatment Week 4 (final week before TQD) | Percent change in smoking behavior (self-reported cigarettes per day; CPD) from timeline follow-back (TLFB) interviews during the pre-quit phase of the study. |
| Secondary | Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification | Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29 | Number of participants with continuous abstinence at the 6-month follow-up (no self-reported smoking during weeks 12-28 AND cotinine level 15 ng/mL or less at EOT and 6 month follow-up) |
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 | Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification | Self-report Treatment Weeks 12-15; bio-verification ~Week 16 | Intent-to-treat analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pre-quit Change in Cigarettes Smoked Per Day | Treatment Week 1 vs. Treatment Week 4 (final week before TQD) | This analysis is not based on ITT, as only participants with complete TLFB data for Weeks 1 and 4 were included in the analysis; early in the trial, pre-quit TLFB was not consistently obtained due to staff error. | percent change in CPD | MEAN |
| SECONDARY | Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification | Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29 | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification | Extended Run-In | 64 | Participants | ||
| Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification | Standard Run-In | 57 | Participants | ||
| Pre-quit Change in Cigarettes Smoked Per Day | Extended Run-In | -38.8 | Standard Error 2.7 | percent change in CPD | |
| Pre-quit Change in Cigarettes Smoked Per Day | Standard Run-In | -17.5 | Standard Error 2.8 | percent change in CPD | |
| Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification | Extended Run-In | 37 | Participants | ||
| Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification | Standard Run-In | 29 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended Run-In | 163 | |
| Overall Study | STARTED | Standard Run-In | 157 | |
| Overall Study | Retained at Wk 15 (EOT) | Extended Run-In | 127 | |
| Overall Study | Retained at Wk 15 (EOT) | Standard Run-In | 126 | |
| Overall Study | Retained at Wk 28 (6-month Follow-up) | Extended Run-In | 124 | |
| Overall Study | Retained at Wk 28 (6-month Follow-up) | Standard Run-In | 121 | |
| Overall Study | COMPLETED | Extended Run-In | 163 | |
| Overall Study | COMPLETED | Standard Run-In | 157 | |
| Overall Study | NOT COMPLETED | Extended Run-In | 0 | |
| Overall Study | NOT COMPLETED | Standard Run-In | 0 |
Source ClinicalTrials.gov
Adverse events180
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 | Nausea | Gastrointestinal disorders | Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group | 13 | 163 | |
| other | Nausea | Gastrointestinal disorders | Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group | 13 | 157 | |
| other | Nausea | Gastrointestinal disorders | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group | 45 | 157 | |
| other | Nausea | Gastrointestinal disorders | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group | 26 | 147 | |
| other | Nausea | Gastrointestinal disorders | Early Quit Phase (Clinic 4 & 5): Extended Run-In Group | 48 | 150 | |
| other | Nausea | Gastrointestinal disorders | Early Quit Phase (Clinic 4 & 5): Standard Run-In Group | 42 | 146 | |
| other | Vomiting | Gastrointestinal disorders | Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group | 1 | 163 | |
| other | Vomiting | Gastrointestinal disorders | Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group | 2 | 157 | |
| other | Vomiting | Gastrointestinal disorders | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group | 11 | 157 | |
| other | Vomiting | Gastrointestinal disorders | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group | 5 | 147 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group | 0 | 163 |
| Total, all-cause mortality | Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group | 0 | 157 |
| Total, all-cause mortality | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group | 0 | 157 |
| Total, all-cause mortality | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group | 0 | 147 |
| Total, all-cause mortality | Early Quit Phase (Clinic 4 & 5): Extended Run-In Group | 0 | 150 |
| Total, all-cause mortality | Early Quit Phase (Clinic 4 & 5): Standard Run-In Group | 0 | 146 |
| Total, other adverse events | Pre-Treatment Phase (Intake Visit & Clinic 1): Extended Run-In Group | 125 | 163 |
| Total, other adverse events | Pre-Treatment Phase (Intake Visit & Clinic 1): Standard Run-In Group | 121 | 157 |
| Total, other adverse events | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Extended Run-In Group | 131 | 157 |
| Total, other adverse events | Pre-Quit Run-In Manip Phase (Clinic 2 & 3): Standard Run-In Group | 104 | 147 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
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 |
|---|---|---|---|---|---|
| R01CA206193 | EVarQuit: Extinguishing cigarette smoking via extended pre-quit varenicline | HAWK, LARRY W; MAHONEY, MARTIN CHRISTOPHER; TIFFANY, STEPHEN T | STATE UNIVERSITY OF NEW YORK AT BUFFALO | NATIONAL CANCER INSTITUTE | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Extended Run-In vs Standard Run-In: Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification | Trial comparisons |
| Extended Run-In vs Standard Run-In: Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification | 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/NCT03262662
GET https://conductscience.org/api/trials/v1/NCT03262662/events?page=2