Assessment of Potential Interactions Between GBR 12909 an... | NCT00100113

Studies
Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

NCT00100113

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

Mar 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

Jun 2004

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Dec 22, 2004

First Submission Date that Met QC Criteria

Dec 22, 2004

First Posted Date

Dec 23, 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 potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

Detailed Description

This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

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
Heart rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be within 20% 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 and are non-treatment seeking at time of study.

Exclusion Criteria:

Please contact 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
Kathryn Cunningham, Ph.D.	University of Texas Medical Branch - Galveston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U of Texas Medical Branch Galveston		Galveston	Texas	77555 1031	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