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

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000306

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders Opioid-Related Disorders	Drug: Dextroamphetamine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

Resource links provided by NLM:

Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	140
Study Start Date:	September 1994
Estimated Study Completion Date:	September 2001

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000306

Locations

United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77225

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Texas

Investigators

Principal Investigator:

John Grabowski, Ph.D.

University of Texas

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000306 History of Changes
Other Study ID Numbers:	NIDA-09262-3, P50-09262-3
Study First Received:	September 20, 1999
Last Updated:	August 11, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Opioid-Related Disorders
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012