Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134901
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-08-23
Brief Title:
Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of the Effectiveness of Memantine in Treating Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Cocaine is one of the most widely abused drugs in the United States Memantine is a type of drug called an NMDA receptor antagonist It works by decreasing normal excitement in the brain NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models as well as lessen conditioned cocaine cues The purpose of this study is to determine the effectiveness of memantine in preventing relapse to cocaine use in cocaine dependent individuals In addition this study will determine whether memantine produces better results than a placebo in decreasing cocaine craving psychological symptoms functional impairment and discontinuation of treatment in cocaine dependent individuals
Detailed Description:
Memantine is a non-competitive NMDA receptor antagonist that works by decreasing normal excitement in the brain Dopamine plays a role in the rewarding and addictive properties of cocaine however past clinical studies have not been successful in using dopamine agonists in treating cocaine dependent individuals Non-competitive NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models and lessen conditioned cocaine cues This study will evaluate memantine in treating cocaine dependent individuals and its ability to prevent relapse to cocaine use Specifically the aim of this study is to determine if memantine is superior to placebo in decreasing cocaine craving psychological symptoms functional impairment and discontinuation of treatment for cocaine abuse
Participants will enter a 2-week single-blind placebo lead-in phase during which they will visit the clinic three times each week At each study visit urine samples and other rating assessments will be collected In addition participants will attend weekly therapy sessions In order to continue in the trial participants are required to attend at least four out of the first six study visits and both therapy sessions Eligible participants will then be randomly assigned to receive either memantine or placebo for the duration of the 12-week double-blind phase of the trial Study visits will continue to occur three times each week participants will also receive weekly therapy Memantine will be taken twice each day Participants who complete the 12-week trial will enter a 2-week lead-out phase during which they will be tapered back to a placebo in a single-blind manner Weekly psychotherapy sessions will continue until the end of Week 14
Participants will enter a 2-week single-blind placebo lead-in phase during which they will visit the clinic three times each week At each study visit urine samples and other rating assessments will be collected In addition participants will attend weekly therapy sessions In order to continue in the trial participants are required to attend at least four out of the first six study visits and both therapy sessions Eligible participants will then be randomly assigned to receive either memantine or placebo for the duration of the 12-week double-blind phase of the trial Study visits will continue to occur three times each week participants will also receive weekly therapy Memantine will be taken twice each day Participants who complete the 12-week trial will enter a 2-week lead-out phase during which they will be tapered back to a placebo in a single-blind manner Weekly psychotherapy sessions will continue until the end of Week 14
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 |
|---|---|---|---|
| P50DA012761 | NIH | None | httpsreporternihgovquickSearchP50DA012761 |