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.