St. John's Wort for Tobacco Cessation
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|ClinicalTrials.gov Identifier: NCT00405912|
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : April 18, 2011
Last Update Posted : April 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Nicotine Dependence||Drug: Placebo Drug: St. John's Wort-900 mg/day Drug: St. John's Wort-1800mg/day||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||St. John's Wort for Tobacco Cessation|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Placebo Comparator: Placeo
Placebo pill was identical in appearance to the active medication.
Placebo (inactive drug) given 3 times per day
Other Name: inactive drug
Experimental: St. John's Wort-900 mg/day
St. John's Wort - 300 mg tablets, 3 times a day.
Drug: St. John's Wort-900 mg/day
St. John's Wort - 300 mg tables -3 times per day
Other Name: St. John's Wort
Experimental: St. John's Wort-1800 mg/day
St. John's Wort - 600 mg 3 times per day
Drug: St. John's Wort-1800mg/day
St. John's Wort - 600 mg tables - 3 times per day
Other Name: SJW
- Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco [ Time Frame: 12 weeks following start of medication ]Point prevalence tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question "Have you used any type of tobacco,even a puff, in the past 7 days?" and (b) Expired Carbon Monoxide equal or less then 8 parts per million.
- Number of Subjects With Prolonged Abstinence From Tobacco [ Time Frame: 24 weeks after the start of medication ]tobacco abstience during the 12-week course of SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day compared to placebo at six months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405912
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amit Sood, M.D., MSc||Mayo Clinic|