GBR 12909 Study in Cocaine Experienced African American V... | NCT00089687

Studies
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

NCT00089687

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

GBR 12909

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

Jan 2005

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

Not provided

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

May 2005

First Submitted Date

Aug 10, 2004

First Submission Date that Met QC Criteria

Aug 10, 2004

First Posted Date

Aug 11, 2004Estimated

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 GBR 12909 in cocaine experienced African American Volunteers.

Detailed Description

Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
GBR 12909	Drug

Measure	Description	Time Frame
pharmacokinetic assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be within 20% of ideal body weight and must weigh at least 45 kg.
Must understand the study procedures and provide written informed consent.
Must meet DSM-4 criteria for abuse or dependence on cocaine.
Must be non-treatment seeking at the time of the study.

Exclusion Criteria:

Please contact the study site for more information.

Accepts Healthy Volunteers

Yes

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
Louis Cantilena, M.D.	Uniformed Services University of Health Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniformed Services University of Health Science		Bethesda	Maryland	20814 4799	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
C043425	vanoxerine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided