Please select the eligibility criteria that correspond to the clinical trial below.
Title: S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
Brief Summary: Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested.

The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter.

To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.


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:

* Patients who smoke at least 10 cigarettes daily and have attempted to quit smoking at least once

Exclusion Criteria:

* Seizure History
* Unstable Blood Pressure
* Current major depression
* Current alcohol/drug abuse or dependency
* Lifetime psychotic illness
* Current use of psychotropic drugs
* Unstable medical condition
C: Inclusion Criteria:

* Is at least 18 years of age;
* Has smoked more than 10 cigarettes/day for ≥6 months;
* Is willing to make a quit attempt;
* Is able to participate fully in all aspects of the study;
* Has been provided with, understand, and have signed the informed consent.
* Is in good health as determined by the physician investigator.

Exclusion Criteria:

* Is clinically significant levels of current depression as assessed by CESD (Score \>16) and determined by the physician; or have a life-time diagnosis of bipolar disorder, schizophrenia or dementia as determined by physician investigator;
* Has an unstable medical condition.
* Is using other tobacco product and the primary use is NOT cigarettes.
* Is currently (within the past 30-days) using antipsychotics or antidepressants;
* Is currently (within the past 30-days) using any treatments for tobacco dependence (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline);
* Is currently using another investigational drug at the time of study enrollment;
* Is currently (within the past 30 days) using an herbal product or dietary supplement for tobacco abstinence;
* Has recent history (in the past 3-months) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators;
* Has a recent history of drug abuse as assessed by physician interview;
* Is pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include diaphragm or condom (with spermicidal), injections, intrauterine device \[IUD\], surgical sterilization and abstinence;
* Is a history of any major cardiovascular events in the past 3-months including unstable angina, acute MI or coronary angioplasty;
* Has clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease;
* Is currently on medications interacting with SAMe, including but not limited to, antidepressants, MAO inhibitors, levodopa, meperidine, dextromethorphan, pentazocine and tramadol;
* Has another household member or relative participating in the study;
* Has known allergy to SAMe.
D: Inclusion Criteria:

* Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
* Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
* Current DSM-IV diagnosis of Nicotine Dependence
* Current DSM-IV diagnosis of Alcohol Dependence
* Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
* An average of at least one pack of cigarettes per day (\>=20 cigarettes/day) over the 7 days prior to intake
* An average of at least 7 drinks over the 7 days prior to intake

Exclusion Criteria:

* Inability to give adequate informed consent
* Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
* Currently taking naltrexone (ReVia), Campral or Antabuse
* Participation in a clinical trial less than 3 months prior to intake
* History of suicide attempt in the past year
* History of hospitalization due to suicidal ideation in the past year
* Suicidal ideation at baseline
* Known allergic reaction to varenicline
* Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.
* Female patients who are pregnant or nursing.
* Significant unstable medical problems (e.g. impaired renal function).
* Significant unstable psychiatric disorders.
* Subjects who do not attend all required screening appointments.
* Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
* Positive urine drug screen for cocaine, opioids or amphetamine at baseline
* Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)
* Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)
* Weight over 250 lbs
* Claustrophobia

Answer: C