Trial Outcomes & Findings for Chantix for Treating Cocaine Dependence (NCT NCT00567008)
NCT ID: NCT00567008
Last Updated: 2013-11-07
Results Overview
Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
8 weeks
Results posted on
2013-11-07
Participant Flow
Thirty-seven treatment-seeking participants from the greater metropolitan Philadelphia area were randomized to participate in this trial.
Participant milestones
| Measure |
Varenicline 2mg/Day
Varenicline (Chantix)
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chantix for Treating Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Varenicline
n=18 Participants
Varenicline (Chantix)
|
Placebo
n=19 Participants
Placebo
|
Total
n=37 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
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.
Outcome measures
| Measure |
Varenicline
n=18 Participants
Varenicline (Chantix)
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|
|
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
|
2 participants
Interval 0.91 to
|
1 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: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=17 participants at risk
Varenicline (Chantix)
|
Placebo
n=18 participants at risk
Placebo
|
|---|---|---|
|
General disorders
Headache
|
17.6%
3/17 • Number of events 4
|
27.8%
5/18 • Number of events 7
|
|
General disorders
Body aches/paines
|
17.6%
3/17 • Number of events 5
|
44.4%
8/18 • Number of events 12
|
|
Gastrointestinal disorders
Cold
|
23.5%
4/17 • Number of events 4
|
0.00%
0/18
|
|
General disorders
Drowsiness
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/17
|
27.8%
5/18 • Number of events 5
|
|
General disorders
Cough
|
11.8%
2/17 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Nighmare
|
5.9%
1/17 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 4
|
16.7%
3/18 • Number of events 3
|
|
General disorders
Insomnia
|
11.8%
2/17 • Number of events 3
|
11.1%
2/18 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place