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NCT00405912 · ClinicalTrials.gov registry record · Phase 2
St. John's Wort for Tobacco Cessation
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT00405912: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT00405912 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 118 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00405912, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
Study Summary
After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 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.
Interventions
- DRUG Placebo
- DRUG St. John's Wort-900 mg/day
- DRUG St. John's Wort-1800mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00405912
The ClinicalTrials.gov registry entry for NCT00405912 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00405912 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00405912 about?
NCT00405912 is a clinical study titled "St. John's Wort for Tobacco Cessation". After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested t...
What is the current status of trial NCT00405912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2005-09. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00405912?
The interventions under investigation include: Placebo (DRUG), St. John's Wort-900 mg/day (DRUG), St. John's Wort-1800mg/day (DRUG).
Who is sponsoring clinical trial NCT00405912?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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