Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218348
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2005-09-16
Brief Title:
Treatment of Cocaine Dependence Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Pharmacotherapy for Cocaine Dependence - 1
Status:
COMPLETED
Status Verified Date:
2017-12
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:
Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence
Detailed Description:
This randomized double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence Participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate 0 mg 40 mg 60 mg or 80 mg Participants will undergo a 2-week stabilization period followed by a 25-week study period The study period will include administration of the stable medication dose for 21 weeks followed by 1 week of dose reduction and then 3 weeks without medication All participants will receive weekly cognitive behavioral therapy and electrocardiograms Participants will be given the option to participate in a voluntary plasma blood draw during Weeks 4 8 and 20 and will be scheduled for follow-up assessments at Months 1 and 3 post-treatment
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 |
|---|---|---|---|
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA016305 |
| R01DA016305 | NIH | None | None |
| R01-16305-1 | None | None | None |