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

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ClinicalTrials.gov Identifier: NCT00218348
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston

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 of dextro-amphetamine sulfate as a treatment for cocaine dependence.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Dextro-Amphetamine Sulfate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacotherapy for Cocaine Dependence - 1
Study Start Date : September 2003
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007





Primary Outcome Measures :
  1. Substance use and retention

Secondary Outcome Measures :
  1. Effectiveness measures, including psycho-social variables, side effects, and self-reported measures


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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

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
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joy M Schmitz, PhD The University of Texas Health Science Center, Houston

Responsible Party: Joy Schmitz, Professor - Psy, Behavioral Science, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00218348     History of Changes
Other Study ID Numbers: NIDA-16305-1
R01DA016305 ( U.S. NIH Grant/Contract )
R01-16305-1
DPMC
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Joy Schmitz, The University of Texas Health Science Center, Houston:
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