St. John's Wort for Tobacco Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00405912
First received: November 29, 2006
Last updated: April 15, 2011
Last verified: April 2011
  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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: St. John's Wort for Tobacco Cessation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco [ Time Frame: 12 weeks following start of medication ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Prolonged Abstinence From Tobacco [ Time Frame: 24 weeks after the start of medication ] [ Designated as safety issue: No ]
    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.


Enrollment: 118
Study Start Date: September 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placeo
Placebo pill was identical in appearance to the active medication.
Drug: Placebo
Placebo (inactive drug) given 3 times per day
Other Names:
  • placebo
  • 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405912

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amit Sood, M.D., MSc Mayo Clinic
  More Information

Publications:
Responsible Party: Amit Sood, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00405912     History of Changes
Other Study ID Numbers: 06-002296
Study First Received: November 29, 2006
Results First Received: January 24, 2011
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014