Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
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The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
Condition or disease
Cocaine-Related DisordersOpioid-Related Disorders
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.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
Keywords provided by National Institute on Drug Abuse (NIDA):
Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants