Trial Outcomes & Findings for St. John's Wort for Tobacco Cessation (NCT NCT00405912)
NCT ID: NCT00405912
Last Updated: 2011-04-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
12 weeks following start of medication
Results posted on
2011-04-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
39
|
|
Overall Study
COMPLETED
|
23
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
16
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
12
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
4
|
Baseline Characteristics
St. John's Wort for Tobacco Cessation
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
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
n=40 Participants
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
n=39 Participants
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
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age Continuous
|
39.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
cigarettes per day
|
19.4 cigarettes per day
STANDARD_DEVIATION 7.3 • n=5 Participants
|
19.1 cigarettes per day
STANDARD_DEVIATION 7.2 • n=7 Participants
|
21.0 cigarettes per day
STANDARD_DEVIATION 5.2 • n=5 Participants
|
19.8 cigarettes per day
STANDARD_DEVIATION 6.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks following start of medicationPoint 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.
Outcome measures
| Measure |
Placebo
n=39 Participants
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
n=40 Participants
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
n=39 Participants
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.
|
|---|---|---|---|
|
Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco
|
7 participants
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 24 weeks after the start of medicationtobacco 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.
Outcome measures
| Measure |
Placebo
n=39 Participants
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
n=40 Participants
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
n=39 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Prolonged Abstinence From Tobacco
|
0 participants
|
1 participants
|
2 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
St. John's Wort - 900 mg /Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
St. John's Wort - 1800 mg /Day
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=39 participants at risk
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
n=40 participants at risk
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
n=39 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal bloating
|
0.00%
0/39
|
0.00%
0/40
|
2.6%
1/39
|
|
Psychiatric disorders
anxiety
|
2.6%
1/39
|
0.00%
0/40
|
0.00%
0/39
|
|
General disorders
dizziness
|
2.6%
1/39
|
0.00%
0/40
|
0.00%
0/39
|
|
General disorders
dry mouth
|
0.00%
0/39
|
0.00%
0/40
|
2.6%
1/39
|
|
General disorders
erectile dysfunction
|
0.00%
0/39
|
0.00%
0/40
|
2.6%
1/39
|
|
General disorders
fatigue
|
2.6%
1/39
|
2.5%
1/40
|
2.6%
1/39
|
|
General disorders
headache
|
2.6%
1/39
|
0.00%
0/40
|
2.6%
1/39
|
|
General disorders
increased anger
|
0.00%
0/39
|
2.5%
1/40
|
0.00%
0/39
|
|
General disorders
increased sweating
|
2.6%
1/39
|
0.00%
0/40
|
0.00%
0/39
|
|
General disorders
insomnia
|
2.6%
1/39
|
10.0%
4/40
|
2.6%
1/39
|
|
General disorders
sleep disturbance
|
0.00%
0/39
|
5.0%
2/40
|
0.00%
0/39
|
|
General disorders
sunburn
|
0.00%
0/39
|
2.5%
1/40
|
0.00%
0/39
|
|
General disorders
trouble concentrating
|
2.6%
1/39
|
0.00%
0/40
|
0.00%
0/39
|
|
General disorders
vivid dreams
|
0.00%
0/39
|
2.5%
1/40
|
2.6%
1/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place