Back to results

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

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

S-Adenosyl-L-Methionine

placebo

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring tobacco use, cigarettes, smokers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic
Franciscan Skemp HealthCare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SAMe 800

SAMe 1600

Placebo

Arm Description

Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM

Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM

Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM

Outcomes

Primary Outcome Measures

7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)

7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)

Secondary Outcome Measures

Full Information

NCT ID

NCT00722124

First Posted

July 23, 2008

Last Updated

August 5, 2011

Sponsor

Mayo Clinic

Collaborators

Pharmavite LLC

1. Study Identification

Unique Protocol Identification Number

NCT00722124

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

Pharmavite LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

tobacco use, cigarettes, smokers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAMe 800

Arm Type

Active Comparator

Arm Description

Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM

Arm Title

SAMe 1600

Arm Type

Active Comparator

Arm Description

Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM

Intervention Type

Drug

Intervention Name(s)

S-Adenosyl-L-Methionine

Other Intervention Name(s)

SAMe

Intervention Description

800 mg dose per day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

S-Adenosyl-L-Methionine

Other Intervention Name(s)

SAMe

Intervention Description

1600 mg per day for 8 weeks

Intervention Type

Other

Intervention Name(s)

placebo

Other Intervention Name(s)

sugar pill

Intervention Description

4 pills (2 in the AM and 2 in the PM) of placebos for 8 weeks

Primary Outcome Measure Information:

Title

7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)

Description

7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Sood, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Franciscan Skemp HealthCare

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs