Could taking chantix for a month before quitting boost success rates?
NCT ID NCT03262662
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested whether taking varenicline (Chantix) for four weeks before quitting smoking, instead of the standard one week, helps more people stay smoke-free. 320 smokers were randomly assigned to either the extended or standard pre-quit schedule, along with counseling. The main goal was to see if the longer run-in led to higher rates of continuous abstinence at the end of treatment and at six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- varenicline (Chantix) and brief smoking cessation counseling
- What this could lead to
- If successful, this could make the best available smoking cessation treatment even more effective by reducing the urge to smoke before quitting, leading to higher long-term quit rates.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to all smokers. Varenicline can cause side effects like nausea, sleep problems, and mood changes. The extended pre-quit period may not improve outcomes for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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320 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Jul 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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State University of New York at Buffalo
Buffalo, New York, 14260, United States
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Other studies related to the condition(s) this trial covers.
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