Viewing Study NCT00000306



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Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000306
Status: COMPLETED
Last Update Posted: 2017-01-12
First Post: 1999-09-20

Brief Title: Dextroamphetamine as Adjunct in CocaineOpiate Dependent Patients - 3
Sponsor: National Institute on Drug Abuse NIDA
Organization: National Institute on Drug Abuse NIDA

Study Overview

Official Title: Dextroamphetamine as an Adjunct in CocaineOpiate Dependent Patients
Status: COMPLETED
Status Verified Date: 2016-10
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: The purpose of this study is to evaluate dextroamphetamine sulfate sustained release as an adjunct in concurrent cocaine and opiate dependent patients
Detailed Description: This 27-week double-blind placebo controlled treatment is designed to evaluate dextroamphetamine sulfate sustained release as an adjunct in concurrent cocaine and opiate dependent patients All subjects will receive methadone For the treatment of cocaine dependence subjects will receive one of 2 doses of dextroamphetamine 15 or 30mg or placebo After 4 weeks of treatment the dose level of dextroamphetamine is doubled 30 or 60mg This dose is maintained for 20 weeks during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy Follow up evaluations will be conducted out to 3 months post treatment Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion

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
P50-09262-3 None None None