NCT00451230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
Last Updated

January 18, 2017

Status Verified

October 1, 2002

Enrollment Period

Same day

First QC Date

March 22, 2007

Last Update Submit

January 17, 2017

Conditions

Cocaine Dependence

Keywords

craving, insulin, leptin

Interventions

cocaineDRUG
hydrocortisoneDRUG

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with DSM IV diagnosis of cocaine dependence, medically healthy

You may not qualify if:

  • Other than cocaine dependence DSM-IV axis I diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02116, United States

Location

Related Publications (1)

  • 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.

    PMID: 18346162DERIVED

MeSH Terms

Conditions

Cocaine-Related DisordersInsulin Resistance

Interventions

CocaineHydrocortisone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Igor Elman

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

June 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

January 18, 2017

Record last verified: 2002-10

Locations

US(1)