Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

This study has been completed.

First Received: September 20, 1999 Last Updated: August 14, 2008 History of Changes

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000304

Purpose

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.

Condition	Intervention	Phase
Cocaine-Related Disorders Substance-Related Disorders	Drug: Dextroamphetamine Drug: D-Amphetamine Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dextroamphetamine as an Adjunct in Cocaine Treatment

Resource links provided by NLM:

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Cocaine hydrochloride Amphetamine sulfate Amphetamine Methamphetamine

U.S. FDA Resources

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

Primary Outcome Measures:

verifiable cocaine abstinence [ Time Frame: 16 weeks of study ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	August 1997
Study Completion Date:	August 2001
Primary Completion Date:	August 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 15/30 mg d-amphetamine	Drug: Dextroamphetamine 15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
2: Experimental 30/60 mg d-amphetamine	Drug: D-Amphetamine 30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
3: Experimental placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Please contact site for information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000304

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

Responsible Party:	University of Texas Medical School at Houston ( F.Gerard Moeller )
Study ID Numbers:	NIDA-09262-1, P50-09262-1
Study First Received:	September 20, 1999
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00000304 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Agents
Adrenergic Agents
Disorders of Environmental Origin
Central Nervous System Stimulants
Methamphetamine
Dopamine

Mental Disorders
Dextroamphetamine
Substance-Related Disorders
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants

Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Mental Disorders
Dextroamphetamine
Therapeutic Uses
Substance-Related Disorders
Dopamine Agents
Amphetamine
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009