Assessment of Potential Interactions Between Cocaine and... | NCT00033059

Studies
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1

NCT00033059

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Unknown status

Last Update Posted

Jan 11, 2017Estimated

Enrollment

Phase

Phase 1

Conditions

Cocaine-Related Disorders

Interventions

Tolcapone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2001

Primary Completion Date

Not provided

Completion Date

Mar 2002

First Submitted Date

Apr 5, 2002

First Submission Date that Met QC Criteria

Apr 5, 2002

First Posted Date

Apr 8, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2017

Last Update Posted Date

Jan 11, 2017Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Tolcapone	Drug

Measure	Description	Time Frame
Safety

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Newton, M.D.	National Institute on Drug Abuse (NIDA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Integrated Substance Abuse Program		Los Angeles	California	90024	United States

Condition Browse Module

MeSH Terms

ID	Term
D019970	Cocaine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077867	Tolcapone

Ancestor Terms

ID	Term
D001577	Benzophenones
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided