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

This study is ongoing, but not recruiting participants.

First Received: April 5, 2002 Last Updated: February 8, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033046

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 I

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Dose Comparison, Crossover Assignment
Official Title:	Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Modafinil

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

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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Neuroprotective Agents
Modafinil
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Anesthetics, Local
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009