Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01281202
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2011-01-20
Brief Title:
Vigabatrin for the Treatment of Cocaine Dependency
Sponsor:
Catalyst Pharmaceuticals Inc
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Vigabatrin for Treatment of Cocaine Dependence A Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling who completely stop use of cocaine in the last 2 weeks of the studys Treatment Phase Weeks 8 and 9 will be higher than seen in subjects treated with placebo in addition to counseling
Detailed Description:
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling who completely stop use of cocaine in the last 2 weeks of the studys Treatment Phase Weeks 8 and 9 will be higher than seen in subjects treated with placebo in addition to counseling
There are 3 Phases to this study
a 2-4 week ScreeningBaseline Phase during which eligibility to be included in the trial will be tested
a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling and
a 15 week Follow-up Phase during the first 4 weeks Weeks 10-13 of which subjects will continue to receive counseling
There are 3 Phases to this study
a 2-4 week ScreeningBaseline Phase during which eligibility to be included in the trial will be tested
a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling and
a 15 week Follow-up Phase during the first 4 weeks Weeks 10-13 of which subjects will continue to receive counseling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y1-DA4006 | OTHER_GRANT | NIDAVA CSP 1030 | None |