Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218348

Purpose

Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Dextro-Amphetamine Sulfate	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, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacotherapy for Cocaine Dependence - 1

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

Primary Outcome Measures:

Substance use and retention

Secondary Outcome Measures:

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

Estimated Enrollment:	140
Study Start Date:	September 2003
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This randomized, double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence. Participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. Participants will undergo a 2-week stabilization period followed by a 25-week study period. The study period will include administration of the stable medication dose for 21 weeks, followed by 1 week of dose reduction, and then 3 weeks without medication. All participants will receive weekly cognitive behavioral therapy and electrocardiograms. Participants will be given the option to participate in a voluntary plasma blood draw during Weeks 4, 8, and 20 and will be scheduled for follow-up assessments at Months 1 and 3 post-treatment.

Eligibility

Ages Eligible for Study:	25 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV
Agreement to use an adequate method of contraception for the duration of the study
Electrocardiogram confirmation by a cardiologist
Cocaine-positive urine test prior to study entry

Exclusion Criteria:

High blood pressure
Significant heart disease
Clinically significant cardiovascular abnormality
Angina
Kidney, liver, or gastrointestinal disorder
Current Axis I disorder not related to drug use
Current dependence on any drug other than nicotine
Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
On probation or parole for reasons other than those related to drug abuse charges
Pregnant or breastfeeding
Sought treatment for drug dependence within 3 months prior to study entry
Currently taking prescribed medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218348

Locations

United States, Texas
Department of Psychiatry, Mental Services
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Joy M Schmitz, PhD

The University of Texas Health Science Center, Houston

More Information

Responsible Party:	University of Texas Health Science Center - Houston ( Joy Schmitz, PhD )
Study ID Numbers:	NIDA-16305-1, R01-16305-1, DPMC
Study First Received:	September 16, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00218348
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine Abuse
Dextro-Amphetamine Sulfate

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 Depressants
Anesthetics
Central Nervous System Stimulants

Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009