Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Data Collection
Narcotic-Related Disorders+3
+ Mental Disorders
+ Opioid-Related Disorders
Treatment Study
Summary
Study start date: September 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas Health Science Center
Houston, United StatesOpen University of Texas Health Science Center in Google Maps