NCT00000306

Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cocaine-Related Disorders
• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Dextroamphetamine

Timeline

• Start date: 1994-09-01
• Completion: 2001-09-01
• First posted: 1999-09-21
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States