Assessment of Potential Interactions Between Cocaine and... | NCT00067535

Studies
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

NCT00067535

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Cocaine-Related Disorders

Interventions

Cocaine-Related Disorders

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2003

Primary Completion Date

Jan 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Aug 21, 2003

First Submission Date that Met QC Criteria

Aug 22, 2003

First Posted Date

Aug 25, 2003Estimated

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 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Detailed Description

Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

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

16Actual

Name	Type	Description	Arm Group Labels	Other Names
Cocaine-Related Disorders	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemodynamic response to cocaine and subjective response to cocaine		3x / 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Includes but is not limited to:

Non-treatment seekers
DSM-IV criteria for cocaine abuse or dependence
Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements

Exclusion Criteria:

Please contact site for more information.

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
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