Clinical trial NCT00000306: Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
Official title: Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Opioid-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-09-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Craving
measure: Drug use
measure: Medication compliance
measure: Retention
measure: Addiction severity
measure: Mood indicators
measure: Psychiatric interview
Secondary outcomes:
measure: Effectiveness measures including psycho-social variables, side effects, and self-reported measures.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: