Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00722124 · ClinicalTrials.gov registry record · Phase 2
S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
A Phase 2 study of Tobacco Dependence, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT00722124 is a Phase 2 study of Tobacco Dependence that has completed, run by Mayo Clinic. The registered enrollment target is 150 participants, below the 473-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00722124, a Phase 2 study of Tobacco Dependence, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER placebo
- DRUG S-Adenosyl-L-Methionine
Study Locations (2)
Minnesota
- Mayo Clinic - Rochester
Wisconsin
- Franciscan Skemp HealthCare - La Crosse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00722124
The ClinicalTrials.gov registry entry for NCT00722124 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (68% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tobacco Dependence appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00722124 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00722124 about?
NCT00722124 is a clinical study titled "S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence". 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 ...
What is the current status of trial NCT00722124?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2008-09. Estimated completion is 2010-06.
What conditions does trial NCT00722124 study?
This clinical trial studies the following conditions: Tobacco Dependence.
What interventions are being tested in trial NCT00722124?
The interventions under investigation include: placebo (OTHER), S-Adenosyl-L-Methionine (DRUG).
Who is sponsoring clinical trial NCT00722124?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00722124 being conducted?
This trial has 2 study locations across Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Cannabidiol for Reducing Cigarette Use
RECRUITING · Phase 2
-
Provider and Peer Delivered Youth Smoking Intervention
COMPLETED · Phase 2
-
Very Low Nicotine Cigarettes in Smokers With Schizophrenia
COMPLETED · Phase 2
-
Harm Reduction for Smokers With Mental Illness
RECRUITING · NA
-
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
RECRUITING · Phase 3
-
Reach Through Equitable Implementation in Utah
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.