Status:
COMPLETED
EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
National Cancer Institute (NCI)
Pfizer
Conditions:
Tobacco Smoking
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03262662
Start Date
October 1 2017
End Date
July 8 2021
Last Update
September 26 2025
Active Locations (1)
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1
State University of New York at Buffalo
Buffalo, New York, United States, 14260