Status:
COMPLETED
St. John's Wort for Tobacco Cessation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Smoking
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
Detailed Description
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. The prevalence of cigarette smoking among U.S. adults has de...
Eligibility Criteria
Inclusion
- A total of 120 subjects will be recruited in the study. Subjects will be eligible to participate if they:
- Are at least 18 years of age;
- Smoked more than10 cigarettes/day for the past one year;
- Willing to make a quit attempt;
- Able to participate fully in all aspects of the study; and
- Have been provided with, understand, and have signed the informed consent.
- Individuals will be excluded from study participation if they:
- 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;
- Are currently (within past 30 days) using antipsychotics or antidepressants;
- Are currently (in previous 30 days) using any treatments for tobacco dependence (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline);
- Have used an investigational drug within the 30 days prior to enrolling in this study;
- Have ever used an herbal product for tobacco cessation;
- Have recent history (in the past 3 months) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators;
- Have a recent history of drug abuse as assessed by the Drug Abuse Screening Test 20 (DAST-20) and physician interview;
- 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;
- Have a history of any major cardiovascular events in the past 6 months including unstable angina, acute MI or coronary angioplasty;
- Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease;
- 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);
- Have another household member or relative participating in the study;
- Have a known allergy to St. John?s Wort;
- Have a history of photosensitivity;
- Are professional drivers or operators of heavy machinery; and
- Are scheduled for a planned surgical procedure within five days of taking SJW.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00405912
Start Date
September 1 2005
End Date
March 1 2008
Last Update
April 19 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905