Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218062
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2005-09-16
Brief Title:
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Pharmacotherapy Dosing Regimen Cocaine Dependence Population
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Cocaine dependence is a major public health problem an effective primary treatment for cocaine dependent individuals has yet to be found The purpose of this study is to examine the effects of d-amphetamine and modafinil when given alone and in combination in treating cocaine dependent individuals
Detailed Description:
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates Due to its widespread use it is important to develop an effective treatment for cocaine dependence Modafinil is a glutamate-enhancing agent D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder Both modafinil and d-amphetamine may be effective treatments for cocaine dependence The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine alone and in combination in treating cocaine dependent individuals
This study will last 16 weeks Participants will be randomly assigned to one of four groups 1 60 mg dose of d-amphetamine 2 400 mg dose of modafinil 3 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil and 4 placebo All participants will receive 200 mg of modafinil over 4 days
This study will last 16 weeks Participants will be randomly assigned to one of four groups 1 60 mg dose of d-amphetamine 2 400 mg dose of modafinil 3 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil and 4 placebo All participants will receive 200 mg of modafinil over 4 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchP50DA009262-12 |
| P50DA009262-12 | NIH | None | None |