Trial Outcomes & Findings for Vigabatrin for Treatment of Cocaine Dependence (NCT NCT00611130)
NCT ID: NCT00611130
Last Updated: 2016-04-13
Results Overview
Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
Week 13
Results posted on
2016-04-13
Participant Flow
01/08-01/09 at 11 US research trial sites.
After Informed Consent obtained, subjects entered a 2-4 week Screening/Baseline Phase to determine whether all Inclusion/Exclusion Criteria were met. Randomization strata included gender, primary method of cocaine administration (snort or intravenous/smoke) \& use in last 30 days (≤18 days or \>18 days)
Participant milestones
| Measure |
CPP-109 Vigabatrin
CPP-109 tablets, 500 mg. 3 Tablets bid.
|
Placebo
Matching Placebo Tablets. 3 tablets bid.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
94
|
|
Overall Study
Completed 12 Week Treatment Phase
|
61
|
64
|
|
Overall Study
COMPLETED
|
43
|
47
|
|
Overall Study
NOT COMPLETED
|
49
|
47
|
Reasons for withdrawal
| Measure |
CPP-109 Vigabatrin
CPP-109 tablets, 500 mg. 3 Tablets bid.
|
Placebo
Matching Placebo Tablets. 3 tablets bid.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
29
|
|
Overall Study
Protocol noncompliance
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Other
|
5
|
4
|
|
Overall Study
Incarceration
|
3
|
2
|
|
Overall Study
Administrative
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Vigabatrin for Treatment of Cocaine Dependence
Baseline characteristics by cohort
| Measure |
CPP-109 Vigabatrin
n=92 Participants
CPP-109 tablets, 500 mg. 3 Tablets bid.
|
Placebo
n=94 Participants
Matching Placebo Tablets. 3 tablets bid.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 7.62 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 8.33 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
94 participants
n=7 Participants
|
186 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 13Population: intent-to-treat
Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.
Outcome measures
| Measure |
CPP-109 Vigabatrin Tablets, 500 mg
n=92 Participants
Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
Matching Placebo Tablets
n=94 Participants
Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
|---|---|---|
|
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
|
7 participants
|
5 participants
|
POST_HOC outcome
Timeframe: Week 2, 4, 6 & 9-11Population: Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 \& 12.
Using retained urine samples and prior to unblinding, up to 12 specimens/ subject were analyzed for vigabatrin levels. Compliance assessment based on \> or = 70% of urines in subjects assigned to vigabatrin having quantitative levels of vigabatrin indicaticative of taking drug within the last 24 hours of clinic visit.
Outcome measures
| Measure |
CPP-109 Vigabatrin Tablets, 500 mg
n=125 Participants
Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
Matching Placebo Tablets
Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
|---|---|---|
|
Medication Compliance
Number of Vigabatrin Completers Analyzed
|
61 participants
|
—
|
|
Medication Compliance
Number Medication Compliant
|
24 participants
|
—
|
Adverse Events
CPP-109 Vigabatrin Tablets, 500 mg
Serious events: 6 serious events
Other events: 73 other events
Deaths: 0 deaths
Matching Placebo Tablet
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPP-109 Vigabatrin Tablets, 500 mg
n=92 participants at risk
Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
Matching Placebo Tablet
n=94 participants at risk
Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
|---|---|---|
|
Psychiatric disorders
Drug Abuse & Major Depression
|
2.2%
2/92
|
0.00%
0/94
|
|
Injury, poisoning and procedural complications
Gun shot wound, road traffic accident & tibia fracture
|
2.2%
2/92
|
0.00%
0/94
|
|
Hepatobiliary disorders
Hepatitis, acute
|
1.1%
1/92
|
0.00%
0/94
|
|
Infections and infestations
Meningitis & Pneumonia
|
1.1%
1/92
|
0.00%
0/94
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/92
|
0.00%
0/94
|
Other adverse events
| Measure |
CPP-109 Vigabatrin Tablets, 500 mg
n=92 participants at risk
Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
Matching Placebo Tablet
n=94 participants at risk
Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
|
|---|---|---|
|
Eye disorders
Photopsia
|
8.7%
8/92
|
1.1%
1/94
|
|
Eye disorders
Blurred vision
|
6.5%
6/92
|
6.4%
6/94
|
|
Eye disorders
Visual disturbance
|
6.5%
6/92
|
3.2%
3/94
|
|
Gastrointestinal disorders
Constipation
|
5.4%
5/92
|
5.3%
5/94
|
|
Gastrointestinal disorders
Diarrhea
|
15.2%
14/92
|
16.0%
15/94
|
|
Gastrointestinal disorders
Nausea
|
9.8%
9/92
|
18.1%
17/94
|
|
Gastrointestinal disorders
Stomach discomfort
|
3.3%
3/92
|
7.4%
7/94
|
|
Gastrointestinal disorders
Toothache
|
2.2%
2/92
|
7.4%
7/94
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92
|
7.4%
7/94
|
|
General disorders
Fatigue
|
7.6%
7/92
|
9.6%
9/94
|
|
Infections and infestations
Nasopharyngitis
|
18.5%
17/92
|
18.1%
17/94
|
|
Investigations
ALT decreased
|
7.6%
7/92
|
0.00%
0/94
|
|
Investigations
CPK increased
|
6.5%
6/92
|
3.2%
3/94
|
|
Investigations
Weight increased
|
5.4%
5/92
|
3.2%
3/94
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
5/92
|
7.4%
7/94
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
8/92
|
10.6%
10/94
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/92
|
6.4%
6/94
|
|
Nervous system disorders
Headache
|
10.9%
10/92
|
27.7%
26/94
|
|
Nervous system disorders
Somnolence
|
5.4%
5/92
|
5.3%
5/94
|
|
Nervous system disorders
Dizziness
|
3.3%
3/92
|
6.4%
6/94
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/92
|
6.4%
6/94
|
|
Psychiatric disorders
Insomnia
|
7.6%
7/92
|
3.2%
3/94
|
Additional Information
M Douglas Winship
Catalyst Pharmaceutical Partners, Inc.
Phone: 305-529-2522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60