Assessment of Potential Interactions Between Cocaine and Tolcapone - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

February 8, 2007

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00033059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

Official Title ^ICMJE

Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Tolcapone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00033059

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CTO-0003-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas Newton, M.D.

National Institute on Drug Abuse (NIDA)

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP