Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Opioid-Related Disorders Clinical Trial

Official title:

Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000306
• Other study ID #: NIDA-09262-3
• Secondary ID: P50-09262-3
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: September 1994
• Est. completion date: September 2001

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Opioid-Related Disorders

Intervention

Drug:
• Dextroamphetamine

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving
Primary	Drug use
Primary	Medication compliance
Primary	Retention
Primary	Addiction severity
Primary	Mood indicators
Primary	Psychiatric interview
Secondary	Effectiveness measures including psycho-social variables, side effects, and self-reported measures.