Metabolic Effects of Cocaine | NCT00451230

Studies
Metabolic Effects of Cocaine

NCT00451230

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

Phase

Not Applicable

Conditions

Cocaine Dependence

Interventions

cocaine
hydrocortisone

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

ID	Type	Description	Link
DA#14410

Status Module

Record Verification Date

Oct 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Mar 22, 2007

First Submission Date that Met QC Criteria

Mar 22, 2007

First Posted Date

Mar 23, 2007Estimated

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 17, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
National Alliance for Research on Schizophrenia and Depression	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals with DSM IV diagnosis of cocaine dependence, medically healthy

Exclusion Criteria:

Other than cocaine dependence DSM-IV axis I diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Igor Elman	MGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02116	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18346162	Derived	Rott D, Langleben DD, Elman I. Cocaine decreases plasma insulin concentrations in non-diabetic subjects: a randomized double-blind study. Diabet Med. 2008 Apr;25(4):510-1. doi: 10.1111/j.1464-5491.2008.02412.x. Epub 2008 Mar 13. No abstract available.

ID	Term
D019970	Cocaine-Related Disorders
D007333	Insulin Resistance

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D006946	Hyperinsulinism

ID	Term
D003042	Cocaine
D006854	Hydrocortisone

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

Name	Type	Description	Arm Group Labels	Other Names
cocaine	Drug
hydrocortisone	Drug