Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373581
Status:
TERMINATED
Last Update Posted:
2016-10-27
First Post:
2006-09-07
Brief Title:
Effects of Vigabatrin on Cocaine Self-Administration
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effects of Vigabatrin on Cocaine Self-Administration
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding ran out
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 study is to determine if vigabatrin will decrease cocaine self-administration cardiovascular effects subjective effects and craving compared to placebo
Detailed Description:
Two recent open label clinical trials have reported that the anticonvulsant gamma vinyl-GABA GVG vigabatrin decreases relapse to cocaine use Brodie et al 2003 2005 Vigabatrin increases neural GABA levels by irreversibly inhibiting the primary GABA degradation enzyme GABA-transaminase the hypothesized mechanism by which vigabatrin decreases cocaine relapse is by increasing GABA levels thereby decreasing the effects of cocaine and cocaine-associated environmental cues on extracellular dopamine concentrations in the mesolimbic dopaminergic pathway Morgan and Dewey 1998 We are proposing to use our model of repeated dose cocaine self-administration to assess the interaction between vigabatrin and smoked cocaine under controlled laboratory conditions This 57-day outpatientinpatient outpatientinpatient protocol will evaluate the effects of vigabatrin maintenance 0 3 gday on cocaine craving subjective effects and self-administration using a within-subjects design Non-treatment seeking cocaine-dependent volunteers will be maintained outpatient for 14 days of vigabatrin maintenance prior to beginning each inpatient study phase During the inpatient phases volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to purchase doses of smoked cocaine 0 12 25 50 mg 5administration In addition to measuring cocaine self-administration we will measure the cardiovascular and subjective effects of repeated cocaine administration and cocaine craving under each vigabatrin maintenance condition Determining vigabatrins effects on a range of smoked cocaine doses will provide essential data on the mechanism of the vigabatrin-cocaine interaction
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 |
|---|---|---|---|
| DA 10755 | OTHER_GRANT | Novel Cocaine Pharmacotherapies | None |