Status:
COMPLETED
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-Related Disorders
Eligibility:
All Genders
25-50 years
Phase:
PHASE2
Brief Summary
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 o...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00218348
Start Date
September 1 2003
End Date
November 1 2007
Last Update
December 19 2017
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030