S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence

In this study, after consenting, subject is screened for study eligibility. If they pass the study screen, they are randomized to study drug (800 mg/day of SAMe, 1600 mg/day of SAMe or placebo-look-alike). Subjects will stay on their assigned dose for 8 weeks with weekly (visits 3-6) or biweekly (visits 7-8) clinic visits. After the 8 weeks of medication, they will receive a phone visit at week 16 and then a final visit at week 24. Study participation ends at the week 24 visit. During study participation, subjects will undergo counseling at every study visit based on the counseling manual, Smoke Free and Living It. They will also keep diaries (record of daily withdraw symptoms and tobacco use) for the 8 weeks while on study medication. At each study visit, smoking and safety outcomes are measured.

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.