Tobacco SmokingPhase 3EVarQuitNCT03262662
EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
A Phase 3 study testing Varenicline and Brief smoking cessation counseling in people with Tobacco Smoking, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Varenicline and Brief smoking cessation counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 8 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking at least 10 cigarettes per day (CPD) for the past 6 months and expired-air carbon monoxide (CO) >7 at intake. NOTE: To reduce exclusion of Black participants, the CPD criterion was reduced to 5 and the carbon monoxide criterion was eliminated in November, 2019.
- At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
- Planning to remain in western New York (NY) during the study period
- Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
- English speaker
- To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.
Who cannot join
- Use of other tobacco products, including e-cigarettes, in past 7 days
- Use of smoking cessation medication, including nicotine replacement therapy, in the past 14 days
- Prior allergy/hypersensitivity to varenicline
- Pregnant or breast-feeding
- Substance use:
- Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and warranting treatment; for those with scores between 8 and 15, the investigators will advise reducing drinking).
Show all 22Show fewer
- Medical treatment for substance use (SU) in past 3 months, including Suboxone (buprenorphine) and methadone (at phone screen)
- Using a combination of the National Institute on Drug Abuse (NIDA) modified ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both at intake):
- Cannabis: ASSIST=27+ (tox screen not used)
- Cocaine: ASSIST=7+ OR positive tox screen
- Methamphetamine: ASSIST=7+ OR positive tox screen
- Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
- Prescription stimulants: With prescription, ASSIST 27+; Without prescription, ASSIST 7+
- Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive tox screen
- (Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems. clinicaltrials.gov edited 12/18/18)
- Psychiatric:
- Antipsychotic medications
- Lifetime history of schizophrenia or bipolar disorder
- Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at intake
- Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating (Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is > 2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory acts or behavior on the C-SSRS).
- Any medical condition, illness, disorder or concomitant medication that compromises participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14260
About this study
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.
- Conditions
- Tobacco Smoking
- Being tested
- Varenicline, Brief smoking cessation counseling
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
oral varenicline tablets
Brief smoking cessation counselingBehavioural
~10-minute individual counseling at each of 6 clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Extended Run-In | Experimental | 4 weeks of varenicline prior to the target quit date (TQD)
+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits Receives: Drug: Varenicline; Behavioral: Brief smoking cessation counseling |
| Standard Run-In | Active comparator | 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD)
+ 11 weeks of post-TQD varenicline
Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.
Brief individual counseling at clinic visits Receives: Drug: Varenicline; Behavioral: Brief smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification
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
Measured: Self-report Treatment Weeks 12-15; bio-verification ~Week 16
Secondary outcomes (2)
Pre-quit Change in Cigarettes Smoked Per Day
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.
Measured: Treatment Week 1 vs. Treatment Week 4 (final week before TQD)
Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification
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)
Measured: Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Oct 2017
- Primary completion5 Apr 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Responsible party
- Principal investigator, Larry Hawk, Ph.D., State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262662
- Sponsor's protocol ID
- STUDY00000911
- Other IDs
- R01CA206193
- Acronym
- EVarQuit
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2017
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share study data through the NIDA-supported NAHDAP repository. IPD to be shared include baseline participant characteristics, intervention group, smoking abstinence, and adverse events.
Publications
Cooper RK, Gass J, Mahoney MC, Tiffany ST, Colder CR, Maguin E, Schlienz NJ, Lawson SC, Tyndale RF, Sandhur B, Hawk LW. Do lab-based assessments of pretreatment smoking reinforcement and cue-specific craving predict smoking cessation with varenicline? Psychol Addict Behav. 2025 Dec;39(8):713-722. doi: 10.1037/adb0001081. Epub 2025 Jul 28.
PubMed 40720285Tonkin S, Gass J, Wray J, Maguin E, Mahoney M, Colder C, Tiffany S, Hawk LW Jr. Evaluating Declines in Compliance With Ecological Momentary Assessment in Longitudinal Health Behavior Research: Analyses From a Clinical Trial. J Med Internet Res. 2023 Jun 22;25:e43826. doi: 10.2196/43826.
PubMed 37347538Hawk LW Jr, Tiffany ST, Colder CR, Ashare RL, Wray JM, Tyndale RF, Brandon TH, Mahoney MC. Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241731. doi: 10.1001/jamanetworkopen.2022.41731.
PubMed 36367720Ferkin AC, Tonkin SS, Maguin E, Mahoney MC, Colder CR, Tiffany ST, Hawk LW. A Psychometric Evaluation of the Stanford Expectations of Treatment Scale (SETS) in the Context of a Smoking Cessation Trial. Nicotine Tob Res. 2022 Nov 12;24(12):1914-1920. doi: 10.1093/ntr/ntac187.
PubMed 35906990Mahoney MC, Park E, Schlienz NJ, Duerr C, Hawk LW. Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation. JMIR Form Res. 2021 Apr 30;5(4):e25541. doi: 10.2196/25541.
PubMed 33878020Lawson SC, Gass JC, Cooper RK Jr, Tonkin SS, Colder CR, Mahoney MC, Tiffany ST, Hawk LW Jr. The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure. Psychopharmacology (Berl). 2021 Feb;238(2):599-609. doi: 10.1007/s00213-020-05713-7. Epub 2020 Nov 21.
PubMed 33219852
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
- ClinicalTrials.gov ID
- NCT03262662
- Acronym / sponsor ID
- EVarQuit / STUDY00000911
- Conditions
- Tobacco Smoking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Pfizer
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Run-In | Experimental | Drug: Varenicline, Behavioral: Brief smoking cessation counseling4 weeks of varenicline prior to the target quit date (TQD) + 11 weeks of post-TQD varenicline Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter. Brief individual counseling at clinic visits |
| Standard Run-In | Active comparator | Drug: Varenicline, Behavioral: Brief smoking cessation counseling3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) + 11 weeks of post-TQD varenicline Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter. Brief individual counseling at clinic visits |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Smoking at least 10 cigarettes per day (CPD) for the past 6 months and expired-air carbon monoxide (CO) >7 at intake. NOTE: To reduce exclusion of Black participants, the CPD criterion was reduced to 5 and the carbon monoxide criterion was eliminated in November, 2019.
- At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
- Planning to remain in western New York (NY) during the study period
- Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
- English speaker
Key exclusion criteria (22 listed)
- Use of other tobacco products, including e-cigarettes, in past 7 days
- Use of smoking cessation medication, including nicotine replacement therapy, in the past 14 days
- Prior allergy/hypersensitivity to varenicline
- Pregnant or breast-feeding
- Substance use:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: Chantixoral varenicline tablets | Drug | Extended Run-In, Standard Run-In |
| Brief smoking cessation counseling~10-minute individual counseling at each of 6 clinic visits | Behavioural | Extended Run-In, Standard Run-In |
Primary outcome
Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification
Time frame: 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
2 secondary outcomes
Pre-quit Change in Cigarettes Smoked Per Day
Time frame: Treatment Week 1 vs. Treatment Week 4 (final week before TQD)
Number of Participants With Continuous Abstinence at 6-Month Follow-Up as Assessed by Self-Report and Bio-verification
Time frame: Self-report Treatment Weeks 12-28; bio-verification ~Week 16 and ~Week 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40720285Cooper RK, Gass J, Mahoney MC, Tiffany ST, Colder CR, Maguin E, Schlienz NJ, Lawson SC, Tyndale RF, Sandhur B, Hawk LW. Do lab-based assessments of pretreatment smoking reinforcement and cue-specific craving predict smoking cessation with varenicline? Psychol Addict Behav. 2025 Dec;39(8):713-722. doi: 10.1037/adb0001081. Epub 2025 Jul 28.
- Derived from this study: PubMed 37347538Tonkin S, Gass J, Wray J, Maguin E, Mahoney M, Colder C, Tiffany S, Hawk LW Jr. Evaluating Declines in Compliance With Ecological Momentary Assessment in Longitudinal Health Behavior Research: Analyses From a Clinical Trial. J Med Internet Res. 2023 Jun 22;25:e43826. doi: 10.2196/43826.
- Derived from this study: PubMed 36367720Hawk LW Jr, Tiffany ST, Colder CR, Ashare RL, Wray JM, Tyndale RF, Brandon TH, Mahoney MC. Effect of Extending the Duration of Prequit Treatment With Varenicline on Smoking Abstinence: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241731. doi: 10.1001/jamanetworkopen.2022.41731.
- Derived from this study: PubMed 35906990Ferkin AC, Tonkin SS, Maguin E, Mahoney MC, Colder CR, Tiffany ST, Hawk LW. A Psychometric Evaluation of the Stanford Expectations of Treatment Scale (SETS) in the Context of a Smoking Cessation Trial. Nicotine Tob Res. 2022 Nov 12;24(12):1914-1920. doi: 10.1093/ntr/ntac187.
- Derived from this study: PubMed 33878020Mahoney MC, Park E, Schlienz NJ, Duerr C, Hawk LW. Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation. JMIR Form Res. 2021 Apr 30;5(4):e25541. doi: 10.2196/25541.
- Derived from this study: PubMed 33219852Lawson SC, Gass JC, Cooper RK Jr, Tonkin SS, Colder CR, Mahoney MC, Tiffany ST, Hawk LW Jr. The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure. Psychopharmacology (Berl). 2021 Feb;238(2):599-609. doi: 10.1007/s00213-020-05713-7. Epub 2020 Nov 21.
- Individual participant dataSharing planned: Yes. We plan to share study data through the NIDA-supported NAHDAP repository. IPD to be shared include baseline participant characteristics, intervention group, smoking abstinence, and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline and Brief smoking cessation counseling in people with Tobacco Smoking, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Continuous Abstinence at End-of-Treatment (EOT) as Assessed by Self-Report and Bio-verification (time frame: Self-report Treatment Weeks 12-15; bio-verification ~Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262662, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.