Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

This study has been completed.

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

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Dextroamphetamine as an Adjunct in Cocaine Treatment

Resource links provided by NLM:

MedlinePlus related topics: Drug Abuse Methamphetamine

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
Experimental: 1 15/30 mg d-amphetamine	Drug: Dextroamphetamine 15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
Experimental: 2 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)
Experimental: 3 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:	F.Gerard Moeller, University of Texas Medical School at Houston
ClinicalTrials.gov Identifier:	NCT00000304 History of Changes
Other Study ID Numbers:	NIDA-09262-1, P50-09262-1
Study First Received:	September 20, 1999
Last Updated:	August 14, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Amphetamine
Methamphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012