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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00218348
First Posted: September 22, 2005
Last Update Posted: January 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacotherapy for Cocaine Dependence - 1

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Joy Schmitz, PhD, University of Texas Health Science Center - Houston
ClinicalTrials.gov Identifier: NCT00218348     History of Changes
Other Study ID Numbers: NIDA-16305-1
R01-16305-1
DPMC
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine Abuse
Dextro-Amphetamine Sulfate

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Amphetamine
Dextroamphetamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors