Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Sep 20, 1999
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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. Follo...
Gender
ALL
Eligibility criteria
- Inclusion Criteria- Subject must:
- • Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
- • Be between 18 and 45 years old
- • Women must agree to use contraception
- • Have an EKG that has been confirmed by a cardiologist
- • Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal
- Exclusion Criteria- Subject must not:
- • • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent
- • Have any Axis I disorder that is not related to drug use
- • Have current dependence on any psychoactive disorder other than nicotine
- • Be on probation or parole for reasons other than those related to drug charges (ASI)
- • Be pregnant or lactating
- • Have been in any outside treatment in 3 months
About National Institute On Drug Abuse (Nida)
The National Institute on Drug Abuse (NIDA) is a leading federal agency within the U.S. Department of Health and Human Services, dedicated to advancing the understanding of drug abuse and addiction through rigorous scientific research. NIDA's mission encompasses the exploration of the biological, behavioral, and social aspects of substance use disorders, facilitating the development of effective prevention and treatment strategies. By funding and conducting innovative clinical trials, NIDA aims to translate research findings into practical solutions that improve public health and inform policy, ultimately contributing to the reduction of substance-related harm in communities across the nation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Trial Officials
John Grabowski, Ph.D.
Principal Investigator
University of Texas
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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