Dextroamphetamine as an Adjunct in Cocaine Treatment - 1 - Full Text View

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

Drug Information available for:

8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Dextroamphetamine Dextroamphetamine sulfate Amphetamine Amphetamine sulfate

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Cocaine-Related Disorders

Dopamine

Mental Disorders

Dextroamphetamine

Substance-Related Disorders

Disorders of Environmental Origin

Amphetamine

Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Uptake Inhibitors

Sympathomimetics

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on December 03, 2008

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