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clinicals

FDA in its Federal Register notice on dietary supplement claims:

(65 Fed. Reg. 1000, 1030, (January 6, 2000) regarding smoking-alternative claims for dietary supplements in Nicodrops): 

1. “Mimics the oral sensations of cigarette smoke”.

2. “Smoking alternative".

3. “Temporarily reduces your desire to smoke”.

Medical Clinical Studies:

Clinicals in one of Nicodrop’s main active ingredients, St. Johns Wort: 

St. John’s Wort for Tobacco Cessation
This study has been completed. First Received on November 29, 2006. Last Updated on April 15, 2011.
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00405912
Purpose:
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.

Nicotine Like Heroin:

JOHNSTON, RI, Feb. 25, 2003 –Bruce Becker, MD, Beth Bock, PhD, and Rosa Carmona-Barros, MS of The Centers for Behavioral & Preventive Medicine, The Miriam Hospital, Rhode Island Hospital, and Brown Medical School. The study found that St. John’s Wort products help to reduce withdrawal symptoms during quitting smoking clinical trials. Dr. Becker presented a paper entitled, “St. John’s Wort Reduces Withdrawal Symptoms During Quitting Smoking” on February 22 at the Society for Research on Nicotine & Tobacco’s 9th Annual Scientific Session being held at the Sheraton New Orleans Hotel.


St. John’s Wort May Aid in Smoking Cessation

For Immediate Release
October 2, 2006

BUFFALO, NY – Smokers who want a “natural” aid to help them stop smoking may be in luck. St. John’s Wort, a herbal agent, appears to be an effective adjunctive therapy for tobacco cessation, according to a pilot study led by Martin C. Mahoney, MD, PhD, Division of Cancer Prevention & Population Sciences at Roswell Park Cancer Institute (RPCI). The results are published in Complementary Therapies in Medicine (2006): 14, 175-184.

The effectiveness of St. John’s Wort for the treatment of mild depression is well known, and its mode of action parallels that of buproprion, which has been shown to be effective in smoking cessation. However, since there have been no peer-reviewed reports evaluating St. John’s Wort for smoking cessation, the pilot study assessed the efficacy of St. John’s Wort by evaluating continuous abstinence rates 12 weeks after quitting and comparing these rates to those of published trials on buproprion.

After a baseline clinic exam, 24 eligible smokers between the ages of 18 and 65 began taking 450 mg of standardized St. John’s Wort twice a day one week before their set quit date. St. John’s Wort was continued throughout the 12-week follow-up period that also included eight telephone calls for counseling and clinic visits every three weeks to monitor depression and anxiety scales and weight, and for carbon monoxide testing to verify their smoking status. 

At the end of 12 weeks, the quit rate was 37.5% (9 of 24). Further, St. John’sWort was generally well tolerated, compliance was high among participants, there were few side effects reported, and none of the quitters had a significant change in weight from their baseline exam.

“Although the results of this study are encouraging, a well-designed, randomized clinical trial will be needed to confirm if St. John’s Wort is effective as a treatment of nicotine dependence,” notes Dr. Mahoney. “If the results withstand such scrutiny, St. John’s Wort may represent a novel treatment to promote smoking cessation and serve as a reasonably priced, over-the-counter alternative to current pharmacotherapies.”

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