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Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 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:
NCT00033059
First received: April 5, 2002
Last updated: February 8, 2007
Last verified: August 2003
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
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

ClinicalTrials.gov Identifier: NCT00033059     History of Changes
Obsolete Identifiers: NCT00024765
Other Study ID Numbers: NIDA-CTO-0003-1
Study First Received: April 5, 2002
Last Updated: February 8, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Tolcapone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013