SmokingPhase 2NCT00405912
St. John's Wort for Tobacco Cessation
A Phase 2 study testing St. John's Wort-900 mg/day and St. John's Wort-1800mg/day in people with Smoking and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Nicotine Dependence
- What is being tested?
- St. John's Wort-900 mg/day and St. John's Wort-1800mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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 declined from 42% in 1965 to 20.9% in 2004. However, the overall decline is not occurring at a rate that will meet national health objectives by 2010. Available pharmacotherapies for the treatment of tobacco dependence are not efficacious for all tobacco users and have an overall estimated efficacy of approximately 20% for long-term tobacco cessation. Thus, novel pharmacotherapies for tobacco cessation need to be explored.
Current smokers tend to be younger with less education and belong to a lower socioeconomic status. Tobacco cessation treatments are expensive and often not covered by Medicare, Medicaid, or third party-payers. Our goal is to evaluate novel, safe, acceptable, effective, and inexpensive therapies that will increase tobacco abstinence rates.
The United States Public Health Service (USPHS) guideline recommends nicotine replacement therapy and bupropion as first-line agents for the treatment of tobacco dependence. Bupropion acts by central dopamine and norepinephrine reuptake inhibition. St. John's Wort (SJW), a widely used herbal product to treat mild to moderate depression, shares a similar mechanism of action and is available as a tobacco cessation aid in a number of over-the-counter preparations. While currently approved pharmacotherapies for tobacco dependence cost between $120-$240 per month, SJW is relatively inexpensive ($15 per month) and is well-tolerated. At present, no randomized prospective study of St. John's Wort for tobacco cessation has been published.
We plan to test the efficacy of SJW for tobacco cessation in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. We will obtain preliminary data about the efficacy of two different oral doses of SJW for improving tobacco abstinence rates and decreasing symptoms of nicotine withdrawal. All subjects will receive a behavioral intervention during participation in the study. A total of 120 subjects will be recruited into the study and randomly allocated to one of the three groups (groups A, B, and C). Participants in group A will receive SJW 300-mg three times a day for twelve weeks while participants in group B will receive SJW 600-mg three times a day for twelve weeks. Participants in group C will receive a matching placebo for the same duration.
We will conduct this research through the Nicotine Research Program (NRP) at the Mayo Clinic in Rochester, Minnesota. We are uniquely situated for completing this research as more than 7,500 patients have been enrolled in over 75 clinical trials conducted through the NRP. We propose the following specific aims:
Primary Aims:
- To obtain preliminary evidence of the effect of a 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 on the 7-day point prevalence tobacco abstinence rates at end of treatment and six months in 120 smokers.
Hypothesis: Cigarette smokers who receive SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day for 12 weeks will have higher 7-day point prevalence tobacco abstinence rates at end of treatment and six months compared to cigarette smokers receiving placebo.
Secondary Aim:
- To obtain preliminary estimates of the effect of a 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 on prolonged tobacco abstinence rates at six months.
Hypothesis: Cigarette smokers who receive SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day for 12-weeks will have higher prolonged tobacco abstinence rates at six months compared to cigarette smokers receiving placebo.
This study is innovative in that we are testing a novel therapeutic agent for the treatment of tobacco use. At the completion of this study, we expect to have obtained preliminary evidence regarding the effect of two different doses of SJW on symptoms of nicotine withdrawal and tobacco abstinence. We will also collect information on adverse effects of SJW in tobacco users and obtain data to plan a larger Phase III clinical trial, if the results from this trial suggest a potential for efficacy.
- Conditions
- Smoking, Nicotine Dependence
- Being tested
- Placebo, St. John's Wort-900 mg/day, St. John's Wort-1800mg/day
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called inactive drug
Placebo (inactive drug) given 3 times per day
St. John's Wort-900 mg/dayDrug
Also called St. John's Wort
St. John's Wort - 300 mg tables -3 times per day
St. John's Wort-1800mg/dayDrug
Also called SJW
St. John's Wort - 600 mg tables - 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Placeo | Placebo comparator | Placebo pill was identical in appearance to the active medication. Receives: Drug: Placebo |
| St. John's Wort-900 mg/day | Experimental | St. John's Wort - 300 mg tablets, 3 times a day. Receives: 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 Receives: Drug: St. John's Wort-1800mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks following start of medication
Secondary outcomes (1)
Number of Subjects With Prolonged Abstinence From Tobacco
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.
Measured: 24 weeks after the start of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startSep 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Amit Sood, M.D., MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405912
- Sponsor's protocol ID
- 06-002296
- Status last verified
- Apr 2011
- First submitted
- 29 Nov 2006
- Last updated
- 19 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20590478Hajizadeh 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.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. John's Wort for Tobacco Cessation
- ClinicalTrials.gov ID
- NCT00405912
- Acronym / sponsor ID
- 06-002296
- Conditions
- Smoking, Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 declined from 42% in 1965 to 20.9% in 2004. However, the overall decline is not occurring at a rate that will meet national health objectives by 2010. Available pharmacotherapies for the treatment of tobacco dependence are not efficacious for all tobacco users and have an overall estimated efficacy of approximately 20% for long-term tobacco cessation. Thus, novel pharmacotherapies for tobacco cessation need to be explored.
Current smokers tend to be younger with less education and belong to a lower socioeconomic status. Tobacco cessation treatments are expensive and often not covered by Medicare, Medicaid, or third party-payers. Our goal is to evaluate novel, safe, acceptable, effective, and inexpensive therapies that will increase tobacco abstinence rates.
The United States Public Health Service (USPHS) guideline recommends nicotine replacement therapy and bupropion as first-line agents for the treatment of tobacco dependence. Bupropion acts by central dopamine and norepinephrine reuptake inhibition. St. John's Wort (SJW), a widely used herbal product to treat mild to moderate depression, shares a similar mechanism of action and is available as a tobacco cessation aid in a number of over-the-counter preparations. While currently approved pharmacotherapies for tobacco dependence cost between $120-$240 per month, SJW is relatively inexpensive ($15 per month) and is well-tolerated. At present, no randomized prospective study of St. John's Wort for tobacco cessation has been published.
We plan to test the efficacy of SJW for tobacco cessation in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. We will obtain preliminary data about the efficacy of two different oral doses of SJW for improving tobacco abstinence rates and decreasing symptoms of nicotine withdrawal. All subjects will receive a behavioral intervention during participation in the study. A total of 120 subjects will be recruited into the study and randomly allocated to one of the three groups (groups A, B, and C). Participants in group A will receive SJW 300-mg three times a day for twelve weeks while participants in group B will receive SJW 600-mg three times a day for twelve weeks. Participants in group C will receive a matching placebo for the same duration.
We will conduct this research through the Nicotine Research Program (NRP) at the Mayo Clinic in Rochester, Minnesota. We are uniquely situated for completing this research as more than 7,500 patients have been enrolled in over 75 clinical trials conducted through the NRP. We propose the following specific aims:
Primary Aims:
- To obtain preliminary evidence of the effect of a 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 on the 7-day point prevalence tobacco abstinence rates at end of treatment and six months in 120 smokers.
Hypothesis: Cigarette smokers who receive SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day for 12 weeks will have higher 7-day point prevalence tobacco abstinence rates at end of treatment and six months compared to cigarette smokers receiving placebo.
Secondary Aim:
- To obtain preliminary estimates of the effect of a 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 on prolonged tobacco abstinence rates at six months.
Hypothesis: Cigarette smokers who receive SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day for 12-weeks will have higher prolonged tobacco abstinence rates at six months compared to cigarette smokers receiving placebo.
This study is innovative in that we are testing a novel therapeutic agent for the treatment of tobacco use. At the completion of this study, we expect to have obtained preliminary evidence regarding the effect of two different doses of SJW on symptoms of nicotine withdrawal and tobacco abstinence. We will also collect information on adverse effects of SJW in tobacco users and obtain data to plan a larger Phase III clinical trial, if the results from this trial suggest a potential for efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placeo | Placebo comparator | Drug: PlaceboPlacebo pill was identical in appearance to the active medication. |
| St. John's Wort-900 mg/day | Experimental | Drug: St. John's Wort-900 mg/daySt. John's Wort - 300 mg tablets, 3 times a day. |
| St. John's Wort-1800 mg/day | Experimental | Drug: St. John's Wort-1800mg/daySt. John's Wort - 600 mg 3 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: inactive drugPlacebo (inactive drug) given 3 times per day | Drug | Placeo |
| St. John's Wort-900 mg/dayAlso: St. John's WortSt. John's Wort - 300 mg tables -3 times per day | Drug | St. John's Wort-900 mg/day |
| St. John's Wort-1800mg/dayAlso: SJWSt. John's Wort - 600 mg tables - 3 times per day | Drug | St. John's Wort-1800 mg/day |
Primary outcome
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.
1 secondary outcome
Number of Subjects With Prolonged Abstinence From Tobacco
Time frame: 24 weeks after the start of medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20590478Sood 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.
- Derived from this study: PubMed 37230961Hajizadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Sood, M.D., MSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing St. John's Wort-900 mg/day and St. John's Wort-1800mg/day in people with Smoking and Nicotine Dependence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (time frame: 12 weeks following start of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011; AzTrials last refreshed its copy on 6 Nov 2026.