Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: St. John's Wort for Tobacco Cessation
Brief 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.


Options:
A: Arm Label: Bupropion (Wellbutrin-SR); Type: ACTIVE_COMPARATOR; Interventions: Drug: Bupropion-SR | Arm Label: Matching Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Bupropion-SR; Assigned to Arm(s): Bupropion (Wellbutrin-SR) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Matching Placebo
B: Arm Label: NicVAX conjugate vaccine; Type: EXPERIMENTAL; Interventions: Biological: NicVAX vaccine, Drug: Varenicline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Drug: Varenicline | Intervention Type: BIOLOGICAL; Name: NicVAX vaccine; Assigned to Arm(s): NicVAX conjugate vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): NicVAX conjugate vaccine, Placebo
C: Arm Label: Placeo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: St. John's Wort-900 mg/day; Type: EXPERIMENTAL; Interventions: Drug: St. John's Wort-900 mg/day | Arm Label: St. John's Wort-1800 mg/day; Type: EXPERIMENTAL; Interventions: Drug: St. John's Wort-1800mg/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placeo | Intervention Type: DRUG; Name: St. John's Wort-900 mg/day; Assigned to Arm(s): St. John's Wort-900 mg/day | Intervention Type: DRUG; Name: St. John's Wort-1800mg/day; Assigned to Arm(s): St. John's Wort-1800 mg/day
D: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): varenicline

Answer: C