Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders
Intervention: Dextro-Amphetamine Sulfate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Joy M Schmitz, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
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 of dextro-amphetamine sulfate as a treatment for cocaine dependence.
Clinical Details
Official title: Pharmacotherapy for Cocaine Dependence - 1
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Substance use and retention
Secondary outcome: Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
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
Minimum age: 25 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Psychiatry, Mental Services, Houston, Texas 77030, United States
Additional Information
Starting date: September 2003
Last updated: January 7, 2009
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