Trial Outcomes & Findings for Vigabatrin for the Treatment of Cocaine Dependency (NCT NCT01281202)
NCT ID: NCT01281202
Last Updated: 2016-05-18
Results Overview
The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
207 participants
Primary outcome timeframe
Weeks 8-9
Results posted on
2016-05-18
Participant Flow
Participant milestones
| Measure |
CPP-109 Vigabatrin Tablets
Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
|
Placebo
Participants received Vigabatrin placebo table orally once daily for 7 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
104
|
|
Overall Study
COMPLETED
|
75
|
68
|
|
Overall Study
NOT COMPLETED
|
28
|
36
|
Reasons for withdrawal
| Measure |
CPP-109 Vigabatrin Tablets
Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
|
Placebo
Participants received Vigabatrin placebo table orally once daily for 7 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
11
|
10
|
|
Overall Study
Administrative
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
|
Overall Study
Incarceration
|
0
|
3
|
Baseline Characteristics
Vigabatrin for the Treatment of Cocaine Dependency
Baseline characteristics by cohort
| Measure |
CPP-109 Vigabatrin Tablets
n=103 Participants
Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
|
Placebo
n=104 Participants
Participants received Vigabatrin placebo table orally once daily for 7 weeks.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
104 participants
n=7 Participants
|
207 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 8-9The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
Outcome measures
| Measure |
CPP-109 Vigabatrin Tablets
n=103 Participants
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
|
Matching Placebo
n=104 Participants
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
|
|---|---|---|
|
Abstinence
|
5 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Week 3 - 9Outcome measures
| Measure |
CPP-109 Vigabatrin Tablets
n=103 Participants
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
|
Matching Placebo
n=104 Participants
Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.
Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
|
|---|---|---|
|
Number of Participants With Cocaine Use
Week 3
|
95 participants
|
96 participants
|
|
Number of Participants With Cocaine Use
Week 4
|
91 participants
|
95 participants
|
|
Number of Participants With Cocaine Use
Week 5
|
88 participants
|
93 participants
|
|
Number of Participants With Cocaine Use
Week 6
|
86 participants
|
90 participants
|
|
Number of Participants With Cocaine Use
Week 7
|
84 participants
|
85 participants
|
|
Number of Participants With Cocaine Use
Week 8
|
83 participants
|
82 participants
|
|
Number of Participants With Cocaine Use
Week 9
|
81 participants
|
81 participants
|
Adverse Events
CPP-109 Vigabatrin Tablets
Serious events: 6 serious events
Other events: 84 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPP-109 Vigabatrin Tablets
n=103 participants at risk
Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
|
Placebo
n=104 participants at risk
Participants received Vigabatrin placebo table orally once daily for 7 weeks.
|
|---|---|---|
|
General disorders
Chest Pain
|
1.9%
2/103
|
0.96%
1/104
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/103
|
0.96%
1/104
|
|
Psychiatric disorders
Psychiatric symptom
|
0.97%
1/103
|
0.00%
0/104
|
|
Investigations
Blood pressure increased
|
0.97%
1/103
|
0.00%
0/104
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/103
|
0.96%
1/104
|
|
Nervous system disorders
Loss of conciousness
|
0.97%
1/103
|
0.00%
0/104
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.97%
1/103
|
0.00%
0/104
|
Other adverse events
| Measure |
CPP-109 Vigabatrin Tablets
n=103 participants at risk
Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
|
Placebo
n=104 participants at risk
Participants received Vigabatrin placebo table orally once daily for 7 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.8%
8/103
|
24.0%
25/104
|
|
Nervous system disorders
Headache
|
21.4%
22/103
|
27.9%
29/104
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
8/103
|
12.5%
13/104
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
11/103
|
7.7%
8/104
|
|
General disorders
Fatigue
|
15.5%
16/103
|
12.5%
13/104
|
|
Psychiatric disorders
Insomnia
|
3.9%
4/103
|
7.7%
8/104
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
8.7%
9/103
|
6.7%
7/104
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
3/103
|
7.7%
8/104
|
|
Eye disorders
Photopsia
|
10.7%
11/103
|
1.9%
2/104
|
|
Investigations
Blood pressure increased
|
7.8%
8/103
|
3.8%
4/104
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
5/103
|
0.96%
1/104
|
|
Vascular disorders
Hypertension
|
3.9%
4/103
|
13.5%
14/104
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.97%
1/103
|
4.8%
5/104
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.9%
4/103
|
2.9%
3/104
|
|
Renal and urinary disorders
Immune system disorders
|
3.9%
4/103
|
2.9%
3/104
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60