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Tobacco DependencePhase 2/3NCT00722124

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

A Phase 2/3 study testing S-Adenosyl-L-Methionine in people with Tobacco Dependence, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Dependence
What is being tested?
S-Adenosyl-L-Methionine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Jun 2010
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Franciscan Skemp HealthCare

    La Crosse, Wisconsin, 54601

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the 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.

Being tested
S-Adenosyl-L-Methionine, placebo
Keywords
tobacco use, cigarettes, smokers
Medical subject headings
Tobacco Use Disorder, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-Adenosyl-L-MethionineDrug

    Also called SAMe

    800 mg dose per day for 8 weeks

  • S-Adenosyl-L-MethionineDrug

    Also called SAMe

    1600 mg per day for 8 weeks

  • placeboOther

    Also called sugar pill

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

Study groups in NCT00722124
Study groupRoleWhat they receive
SAMe 800Active comparatorEach 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
Receives: Drug: S-Adenosyl-L-Methionine
SAMe 1600Active comparatorEach person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
Receives: Drug: S-Adenosyl-L-Methionine
PlaceboPlacebo comparatorEach subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722124
Sponsor's protocol ID
07-006365
Other IDs
07-006604
Status last verified
Aug 2011
First submitted
23 Jul 2008
Last updated
9 Sep 2011
Data monitoring committee
No

Publications

  • Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

    PubMed 37230961

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing S-Adenosyl-L-Methionine in people with Tobacco Dependence, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.

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