Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 11, 2008

Start Date ^ICMJE

September 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Craving
Drug use
Medication compliance
Retention
Addiction severity
Mood indicators
Psychiatric interview

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000306 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effectiveness measures including psycho-social variables, side effects, and self-reported measures.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Official Title ^ICMJE

Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cocaine-Related Disorders
Opioid-Related Disorders

Intervention ^ICMJE

Drug: Dextroamphetamine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

September 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000306

Responsible Party

Study ID Numbers ^ICMJE

NIDA-09262-3, P50-09262-3

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Texas

Investigators ^ICMJE

Principal Investigator:

John Grabowski, Ph.D.

University of Texas

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP