Status:
COMPLETED
S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Pharmavite LLC
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 decl...
Detailed Description
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-al...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00722124
Start Date
September 1 2008
End Date
June 1 2010
Last Update
September 9 2011
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Franciscan Skemp HealthCare
La Crosse, Wisconsin, United States, 54601