St. John's Wort for Tobacco Cessation

NCT00405912 | Completed Phase 2 Results

• 1 other identifier: 06-002296
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco

  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.

  12 weeks following start of medication

Secondary Outcomes (1)

• Number of Subjects With Prolonged Abstinence From Tobacco

  24 weeks after the start of medication

Study Arms (3)

Placeo

PLACEBO COMPARATOR

Placebo pill was identical in appearance to the active medication.

Drug: Placebo

St. John's Wort-900 mg/day

EXPERIMENTAL

St. John's Wort - 300 mg tablets, 3 times a day.

Drug: St. John's Wort-900 mg/day

St. John's Wort-1800 mg/day

EXPERIMENTAL

St. John's Wort - 600 mg 3 times per day

Drug: St. John's Wort-1800mg/day

Interventions

Placebo DRUG

Placebo (inactive drug) given 3 times per day

Also known as: inactive drug

Placeo

St. John's Wort-900 mg/day DRUG

St. John's Wort - 300 mg tables -3 times per day

Also known as: St. John's Wort

St. John's Wort-900 mg/day

St. John's Wort-1800mg/day DRUG

St. John's Wort - 600 mg tables - 3 times per day

Also known as: SJW

St. John's Wort-1800 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 20590478 RESULT

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Amit Sood
• Organization: Mayo Clinic

nicotineresearch@mayo.edu

507-266-1944

Study Officials

• Amit Sood, M.D., MSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: September 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 19, 2011
• Results First Posted: April 18, 2011

Record last verified: 2011-04

Locations

US (1)