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:

* resident into the Abruzzo and Lazio Region
* aged between 30 and 75 years;
* smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group);
* smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group);
* smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group).

Exclusion Criteria:

* illicit drug use,
* breastfeeding or pregnancy,
* major depression or other psychiatric conditions,
* severe allergies,
* active antihypertensive medication,
* angina pectoris,
* past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.
B: Inclusion Criteria:

* Smokers aged 18 years or above and wanting to stop smoking
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
C: 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
D: Inclusion Criteria:

* Veteran status
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
* Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
* Be willing to make an attempt to quit smoking in the next 30 days
* Be capable of providing informed consent
* Have access to a telephone (land line or cell phone)
* Have a stable residence

Exclusion Criteria:

* Planning to move within the next 12 months
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized

Answer: C