Dextroamphetamine-Cocaine Behavioral Intervention - 5 - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000308

Purpose

The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Dextroamphetamine Drug: D-amphetamine Drug: placebo	Phase II

MedlinePlus related topics: Methamphetamine

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 Methamphetamine

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:	D-Amphetamine-Cocaine Behavioral Intervention

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:	54
Study Start Date:	September 1995
Study Completion Date:	September 2000
Primary Completion Date:	September 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks	Drug: Dextroamphetamine 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
2: Experimental 30 mg of d-amphetamine for first 8 weeks of study and 60 mg for the second 8 weeks	Drug: D-amphetamine 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
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: NCT00000308

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, M.D. )
Study ID Numbers:	NIDA-09262-5, P50-09262-5
Study First Received:	September 20, 1999
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00000308
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Methamphetamine
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
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs

Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009