Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

St. John's Wort for Tobacco Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405912
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : April 18, 2011
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 118
Recruitment Details 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  
Arm/Group Title Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Hide Arm/Group Description 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 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 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.
Period Title: Overall Study
Started 39 40 39
Completed 23 21 23
Not Completed 16 19 16
Reason Not Completed
Withdrawal by Subject             12             11             12
Lost to Follow-up             4             8             4
Arm/Group Title Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day Total
Hide Arm/Group Description 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 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 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 of all reporting groups
Overall Number of Baseline Participants 39 40 39 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 39 participants 118 participants
<=18 years
0
   0.0%
1
   2.5%
1
   2.6%
2
   1.7%
Between 18 and 65 years
38
  97.4%
38
  95.0%
38
  97.4%
114
  96.6%
>=65 years
1
   2.6%
1
   2.5%
0
   0.0%
2
   1.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 40 participants 39 participants 118 participants
39.4  (13.0) 38.3  (11.9) 35.0  (12.2) 37.6  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 40 participants 39 participants 118 participants
Female
26
  66.7%
18
  45.0%
21
  53.8%
65
  55.1%
Male
13
  33.3%
22
  55.0%
18
  46.2%
53
  44.9%
cigarettes per day   [1] 
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 39 participants 40 participants 39 participants 118 participants
19.4  (7.3) 19.1  (7.2) 21.0  (5.2) 19.8  (6.6)
[1]
Measure Description: Self Reported average number of cigarettes smoked per day in the preceding 6 months prior to study enrollment.
1.Primary Outcome
Title Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco
Hide Description 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.
Time Frame 12 weeks following start of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 39 40 39
Measure Type: Number
Unit of Measure: participants
7 8 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, St. John's Wort - 900 mg /Day
Comments Data were compared between treatment groups using Fisher's exact test for binary outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Fisher Exact
Comments 1 sided test
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, St. John's Wort - 1800 mg /Day
Comments Data were compared between treatment groups using Fisher's exact test for binary outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Fisher Exact
Comments 1-sided test
2.Secondary Outcome
Title Number of Subjects With Prolonged Abstinence From Tobacco
Hide Description 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.
Time Frame 24 weeks after the start of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 39 40 39
Measure Type: Number
Unit of Measure: participants
0 1 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, St. John's Wort - 900 mg /Day
Comments Data were compared between treatment groups using Fisher's exact test for binary outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Fisher Exact
Comments 1-sided test
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, St. John's Wort - 1800 mg /Day
Comments Data were compared between treatment groups using Fisher's exact test for binary outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Fisher Exact
Comments 1-sided test
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/40 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo St. John's Wort - 900 mg /Day St. John's Wort - 1800 mg /Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/39 (15.38%)   9/40 (22.50%)   5/39 (12.82%) 
Gastrointestinal disorders       
abdominal bloating *  0/39 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
General disorders       
dizziness *  1/39 (2.56%)  0/40 (0.00%)  0/39 (0.00%) 
dry mouth *  0/39 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
erectile dysfunction *  0/39 (0.00%)  0/40 (0.00%)  1/39 (2.56%) 
fatigue *  1/39 (2.56%)  1/40 (2.50%)  1/39 (2.56%) 
headache *  1/39 (2.56%)  0/40 (0.00%)  1/39 (2.56%) 
increased anger *  0/39 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
increased sweating *  1/39 (2.56%)  0/40 (0.00%)  0/39 (0.00%) 
insomnia *  1/39 (2.56%)  4/40 (10.00%)  1/39 (2.56%) 
sleep disturbance *  0/39 (0.00%)  2/40 (5.00%)  0/39 (0.00%) 
sunburn *  0/39 (0.00%)  1/40 (2.50%)  0/39 (0.00%) 
trouble concentrating *  1/39 (2.56%)  0/40 (0.00%)  0/39 (0.00%) 
vivid dreams *  0/39 (0.00%)  1/40 (2.50%)  1/39 (2.56%) 
Psychiatric disorders       
anxiety *  1/39 (2.56%)  0/40 (0.00%)  0/39 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amit Sood
Organization: Mayo Clinic
Phone: 507-266-1944
EMail: nicotineresearch@mayo.edu
Layout table for additonal information
Responsible Party: Amit Sood, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00405912    
Other Study ID Numbers: 06-002296
First Submitted: November 29, 2006
First Posted: November 30, 2006
Results First Submitted: January 24, 2011
Results First Posted: April 18, 2011
Last Update Posted: April 19, 2011