Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

This study is ongoing, but not recruiting participants.

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

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033059

Purpose

The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Tolcapone	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone

Resource links provided by NLM:

Drug Information available for: Tolcapone

U.S. FDA Resources

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

Primary Outcome Measures:

Safety

Estimated Enrollment:	16
Study Start Date:	July 2001
Estimated Study Completion Date:	March 2002

Detailed Description:

Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence

Exclusion Criteria:

Additional criteria available during screening at the site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033059

Locations

United States, California
UCLA Integrated Substance Abuse Program
Los Angeles, California, United States, 90024

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Thomas Newton, M.D.

National Institute on Drug Abuse (NIDA)

More Information

No publications provided

Study ID Numbers:	NIDA-CTO-0003-1
Study First Received:	April 5, 2002
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00033059 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Mental Disorders
Tolcapone

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Cocaine-Related Disorders
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Mental Disorders
Therapeutic Uses
Tolcapone

Substance-Related Disorders
Antiparkinson Agents
Disorders of Environmental Origin
Enzyme Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009