Please select the eligibility criteria that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Methadone Maintenance Patients
Brief Summary: Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.


Options:
A: Inclusion Criteria:

* Self-identified African American
* Smokes ≥ 1 cigarette per day (cpd)
* Smoke on ≥ 25 days of the past 30 days
* Functioning telephone
* Interested in quitting smoking
* Interested in taking 3 months of varenicline
* Willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to varenicline
* A cardiovascular event in the past month
* History of alcohol or drug dependence in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder, psychosis, bipolar disorder, or eating disorders
* Use of tobacco products other than cigarettes in past 30 days
* Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study
* Evidence of current severe major depressive disorder or suicidal ideation
B: Inclusion Criteria:

* Age 14-21
* Daily smoker for ≥6 months
* Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
* If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
* If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

Exclusion Criteria:

* Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
* Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
* Current substance dependence, other than nicotine
* Current unstable major medical disorder
* Current pregnancy or breastfeeding
* Current use of medications with smoking cessation efficacy
* Known hypersensitivity to varenicline
C: 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.
D: Inclusion Criteria:

* Age 18 or older
* English speaking
* Smoked at least 100 cigarettes/lifetime
* Smokes 5 or more cigarettes per day
* Interested in quitting smoking (preparation or contemplation state of change)
* Enrolled in Einstein/Montefiore methadone program for 3 or more months
* Stable methadone dose for 2 weeks
* Agree to use contraception throughout the trial (among women with reproductive potential)
* Willing to participate in all study components
* Able to provide informed consent

Exclusion Criteria:

* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
* Psychiatric instability
* Women who are pregnant, breastfeeding, or contemplating pregnancy
* Creatinine clearance less than 30 mL/min

Answer: D