Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
State University of New York at Buffalo
With
National Cancer Institute (NCI)
Pfizer
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
(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.
You may not be if
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
