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Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

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ClinicalTrials.gov Identifier: NCT00033046
Recruitment Status : Unknown
Verified May 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2002
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug Administration Schedule Infusions, Intravenous Drug: Modafinil Phase 1

Detailed Description:
Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
Study Start Date : June 2001
Estimated Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. pharmacokinetic parmaters at steady state
  2. BP, HR

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

Exclusion Criteria:

Additional criteria available during screening at the site

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): NCT00033046


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425 742
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Robert Malcolm, M.D. Medical University of South Carolina
More Information

ClinicalTrials.gov Identifier: NCT00033046     History of Changes
Obsolete Identifiers: NCT00024752
Other Study ID Numbers: NIDA-CTO-0002-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: May 2004

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Modafinil
Armodafinil
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
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers