St. John's Wort for Tobacco Cessation

• ClinicalTrials.gov Identifier: NCT00405912
• Recruitment Status: Completed
• First Posted: November 30, 2006
• Results First Posted: April 18, 2011
• Last Update Posted: April 19, 2011
• Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Information provided by: Mayo Clinic

Study Description

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.

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

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placeo; Placebo pill was identical in appearance to the active medication.	Drug: Placebo; 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

A total of 120 subjects will be recruited in the study. Subjects will be eligible to participate if they:

1. Are at least 18 years of age;
2. Smoked more than10 cigarettes/day for the past one year;
3. Willing to make a quit attempt;
4. Able to participate fully in all aspects of the study; and
5. Have been provided with, understand, and have signed the informed consent.

Individuals will be excluded from study participation if they:

1. Meet diagnostic criteria for current major depressive disorder or lifetime history of bipolar disorder or schizophrenia. Patients with mild or moderate depressive symptoms [Beck Depression Inventory, Second Edition ≤ 28], but who do not meet current diagnostic criteria for major depressive disorder, will be included;
2. Are currently (within past 30 days) using antipsychotics or antidepressants;
3. Are currently (in previous 30 days) using any treatments for tobacco dependence (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline);
4. Have used an investigational drug within the 30 days prior to enrolling in this study;
5. Have ever used an herbal product for tobacco cessation;
6. Have recent history (in the past 3 months) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators;
7. Have a recent history of drug abuse as assessed by the Drug Abuse Screening Test 20 (DAST-20) and physician interview;
8. Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use a reliable form of contraception. Reliable forms of contraception include barrier (diaphragm or condom with spermicidal jelly), injections, intrauterine device [IUD], surgical sterilization and abstinence;
9. Have a history of any major cardiovascular events in the past 6 months including unstable angina, acute MI or coronary angioplasty;
10. Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease;
11. Are currently on medications interacting with St. John?s Wort including warfarin, antiretrovirals (particularly indinavir and nevirapine), cyclosporine and tacrolimus, digoxin, nifedipine and verapamil, theophylline, all serotonergic drugs (serotonin reuptake inhibitors, tricyclic antidepressants, tramadol, venlafaxine, tryptophan and buspirone), MAO inhibitors, oral contraceptives, anti-cancer agents including imatinib and irinotecan, migraine medications (sumatriptan and zolmitriptan), methadone, lithium, sibutramine, atorvastatin and simvastatin, midazolam, alprazolam, fexofenadine, omeprazole, and general anesthetics (fentanyl, propofol, and sevoflurane);
12. Have another household member or relative participating in the study;
13. Have a known allergy to St. John?s Wort;
14. Have a history of photosensitivity;
15. Are professional drivers or operators of heavy machinery; and
16. Are scheduled for a planned surgical procedure within five days of taking SJW.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Amit Sood, M.D., MSc; Mayo Clinic

More Information

Publications of Results:

Sood A, Ebbert JO, Prasad K, Croghan IT, Bauer B, Schroeder DR. A randomized clinical trial of St. John's wort for smoking cessation. J Altern Complement Med. 2010 Jul;16(7):761-7. doi: 10.1089/acm.2009.0445.

• Responsible Party: Amit Sood, M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00405912 History of Changes
• Other Study ID Numbers: 06-002296
• First Posted: November 30, 2006
• Results First Posted: April 18, 2011
• Last Update Posted: April 19, 2011
• Last Verified: April 2011

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders