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:

* 12-21 years of age
* arriving for routine care to dental office

Exclusion Criteria:

* dentally, medically, or psychologically unstable at the time of the visit
* cannot read or understand English at a 6th grade level
* unavailable for 1-month post-visit assessment
B: Inclusion Criteria:

* Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
* State that they are under the care of a primary care physician
* Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Speak English
* Answer "no" to the following 3 questions:

  * "Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
  * "Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
  * "Is there any reason that you cannot use varenicline/Chantix?"

Exclusion Criteria:

* State that they are not under the care of a primary care physician
* Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
* Do not speak English
* Answer "yes" to the question, "have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder?"
* Answer "yes" to the question, "have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself?"
* Answer "yes" to the question, "is there any reason that you cannot use varenicline/Chantix?"
* Are women who are currently pregnant
* Report that they are unwilling to receive or take varenicline on screening
C: Inclusion Criteria:

* Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
* Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
* Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

* PANSS score \>70 at Screen or Baseline Visit.
* Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
* Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
* Subjects taking Bupropion.
D: 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.

Answer: D