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
Results First Received: January 24, 2011  
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
Conditions: Smoking
Nicotine Dependence
Interventions: Drug: Placebo
Drug: St. John's Wort-900 mg/day
Drug: St. John's Wort-1800mg/day

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began on 06/01/2006 and completed on 11/08/2007. Interested subjects who passed a phone prescreen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
St. John's Wort - 900 mg /Day St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
St. John's Wort - 1800 mg /Day St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.

Participant Flow:   Overall Study
    Placebo     St. John's Wort - 900 mg /Day     St. John's Wort - 1800 mg /Day  
STARTED     39     40     39  
COMPLETED     23     21     23  
NOT COMPLETED     16     19     16  
Withdrawal by Subject                 12                 11                 12  
Lost to Follow-up                 4                 8                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
St. John's Wort - 900 mg /Day St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
St. John's Wort - 1800 mg /Day St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     St. John's Wort - 900 mg /Day     St. John's Wort - 1800 mg /Day     Total  
Number of Participants  
[units: participants]
  39     40     39     118  
Age  
[units: participants]
       
<=18 years     0     1     1     2  
Between 18 and 65 years     38     38     38     114  
>=65 years     1     1     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  39.4  ± 13.0     38.3  ± 11.9     35.0  ± 12.2     37.6  ± 12.4  
Gender  
[units: participants]
       
Female     26     18     21     65  
Male     13     22     18     53  
cigarettes per day [1]
[units: cigarettes per day]
Mean ± Standard Deviation
  19.4  ± 7.3     19.1  ± 7.2     21.0  ± 5.2     19.8  ± 6.6  
[1] Self Reported average number of cigarettes smoked per day in the preceding 6 months prior to study enrollment.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco   [ Time Frame: 12 weeks following start of medication ]

2.  Secondary:   Number of Subjects With Prolonged Abstinence From Tobacco   [ Time Frame: 24 weeks after the start of medication ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Amit Sood
Organization: Mayo Clinic
phone: 507-266-1944
e-mail: nicotineresearch@mayo.edu


Publications of Results:

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