NCT00087750

Brief Summary

The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2003

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
Last Updated

January 11, 2017

Status Verified

March 1, 2005

First QC Date

July 13, 2004

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • Adverse events

  • pharmacokinetic assessment

Interventions

QuetiapineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Includes but is not limited to: non-treatment seeking individuals. Must meet DSM-IV criteria for cocaine abuse or dependence. Must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. Site will provide further details.

You may not qualify if:

  • Please contact site for further information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Domenic Ciraulo, M.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 13, 2004

First Posted

July 16, 2004

Study Start

October 1, 2003

Last Updated

January 11, 2017

Record last verified: 2005-03

Locations

US(1)