Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129285
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2005-08-04
Brief Title:
Modafinil Treatment for Cocaine-Dependent Individuals
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Modafinil for Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Despite years of active research there are still no approved medications for the treatment of cocaine dependence The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals
Detailed Description:
Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled conditions Due to its stimulant-like properties modafinil is also likely to relieve severe cocaine withdrawal symptoms In turn this may lead to better clinical outcomes The purpose of this study is to determine whether modafinil improves abstinence during early recovery from cocaine dependence
This 6-month double-blind placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence Treatment will occur for 8 weeks Participants will be randomly assigned to receive a single morning dose of low-dose modafinil 200 mgday high-dose modafinil 400 mgday or matching placebo tablets In addition each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center At the end of the 8-week treatment period modafinil or placebo will be abruptly discontinued One week following an end of medication evaluation will occur In addition to this two follow-up evaluations will take place 3 and 5 months after initial randomization Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment Urine benzoylecgonine levels will be used to measure cocaine abstinence Craving withdrawal retention and adverse events will also be evaluated
This 6-month double-blind placebo-controlled trial will enroll 210 participants with current DSM-IV diagnoses of cocaine dependence Treatment will occur for 8 weeks Participants will be randomly assigned to receive a single morning dose of low-dose modafinil 200 mgday high-dose modafinil 400 mgday or matching placebo tablets In addition each week participants will receive manual-guided cognitive behavioral therapy at the Treatment Research Center At the end of the 8-week treatment period modafinil or placebo will be abruptly discontinued One week following an end of medication evaluation will occur In addition to this two follow-up evaluations will take place 3 and 5 months after initial randomization Efforts will be made to continue evaluation of subjects who decide to discontinue the modafinil treatment Urine benzoylecgonine levels will be used to measure cocaine abstinence Craving withdrawal retention and adverse events will also be evaluated
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 |
|---|---|---|---|
| 704450 | Other Identifier | NIDA | httpsreporternihgovquickSearchR01DA015366 |
| R01DA015366 | NIH | None | None |
| DPMC | OTHER | None | None |