NCT00033059

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
Last Updated

January 11, 2017

Status Verified

August 1, 2003

First QC Date

April 5, 2002

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Safety

Interventions

TolcaponeDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Additional criteria available during screening at the site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Integrated Substance Abuse Program

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Tolcapone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsNitrophenolsPhenolsKetonesNitro Compounds

Study Officials

  • Thomas Newton, M.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

July 1, 2001

Study Completion

March 1, 2002

Last Updated

January 11, 2017

Record last verified: 2003-08

Locations

US(1)