Trial Outcomes & Findings for Varenicline for the Treatment of Smokeless Tobacco (NCT NCT00813917)
NCT ID: NCT00813917
Last Updated: 2012-07-16
Results Overview
7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
12 weeks - end of treatment
Results posted on
2012-07-16
Participant Flow
Recruitment began on 4/13/09 and completed on 08/16/10. Interested subjects who passed a phone pre-screen 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 |
Varenicline
varenicline-1mg/day for 12 weeks
|
Placebo
nonactive lookalike pill per day for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Varenicline
varenicline-1mg/day for 12 weeks
|
Placebo
nonactive lookalike pill per day for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Varenicline for the Treatment of Smokeless Tobacco
Baseline characteristics by cohort
| Measure |
Varenicline
n=38 Participants
varenicline-1mg/day for 12 weeks
|
Placebo
n=38 Participants
nonactive lookalike pill per day for 12 weeks
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
41.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
smokeless tobacco quantity
|
4.0 cans per week
STANDARD_DEVIATION 3.5 • n=5 Participants
|
3.2 cans per week
STANDARD_DEVIATION 2.0 • n=7 Participants
|
3.6 cans per week
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks - end of treatment7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml
Outcome measures
| Measure |
Varenicline
n=38 Participants
varenicline-1mg/day for 12 weeks
|
Placebo
n=38 Participants
nonactive lookalike pill per day for 12 weeks
|
|---|---|---|
|
7-day Point Prevalence All Tobacco Abstinence
|
21 participants
|
16 participants
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
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 |
Varenicline
n=38 participants at risk
varenicline-1mg/day for 12 weeks
|
Placebo
n=38 participants at risk
nonactive lookalike pill per day for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.7%
9/38
|
0.00%
0/38
|
|
General disorders
sleep disturbance
|
18.4%
7/38
|
7.9%
3/38
|
|
General disorders
vivid dreams
|
7.9%
3/38
|
2.6%
1/38
|
|
General disorders
headache
|
2.6%
1/38
|
2.6%
1/38
|
|
General disorders
confusion
|
0.00%
0/38
|
2.6%
1/38
|
|
Gastrointestinal disorders
constipation
|
2.6%
1/38
|
0.00%
0/38
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/38
|
2.6%
1/38
|
|
General disorders
dizziness
|
2.6%
1/38
|
0.00%
0/38
|
|
General disorders
hives
|
2.6%
1/38
|
0.00%
0/38
|
|
General disorders
irritability
|
2.6%
1/38
|
0.00%
0/38
|
|
General disorders
mood disturbance
|
0.00%
0/38
|
2.6%
1/38
|
|
General disorders
restlessness
|
0.00%
0/38
|
2.6%
1/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place