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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00033046
First received: April 5, 2002
Last updated: February 8, 2007
Last verified: May 2004
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

Resource links provided by NLM:

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • pharmacokinetic parmaters at steady state
  • BP, HR

Estimated Enrollment: 12
Study Start Date: June 2001
Estimated Study Completion Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00033046     History of Changes
Obsolete Identifiers: NCT00024752
Other Study ID Numbers: NIDA-CTO-0002-1
Study First Received: April 5, 2002
Last Updated: February 8, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Modafinil
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013