Development of Human Laboratory Study Model of Cocaine Re... | NCT00094315

Studies
Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1

NCT00094315

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

Cocaine (IV)

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

Sep 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

Sep 2004

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Oct 15, 2004

First Submission Date that Met QC Criteria

Oct 14, 2004

First Posted Date

Oct 15, 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

To study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

Detailed Description

This is a single-site, double-blind, placebo-controlled crossover study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Cocaine (IV)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be English-speaking volunteers who are cocaine dependent
Be non-treatment seeking at the time of the study
Meet DSM-IV criteria for cocaine dependence
Have ECG showing normal sinus rhythm, normal conductivity, and non clinically significant arrhythmias
Females must provide a negative pregnancy test and agree to use birth control
Have baseline laboratory tests within normal limits

Exclusion Criteria:

Please contact 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

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Roache, Ph.D.	University of Texas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center		San Antonio	Texas	78284	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
D003042	Cocaine

Ancestor Terms

ID	Term
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Stimulated and non-stimulated craving
Cocaine assessment