Interaction Between Cocaine and Quetiapine - 1

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00087750

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Quetiapine	Phase I

Drug Information available for: Quetiapine Quetiapine fumarate 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety Study
Official Title:	Interaction Between IV Cocaine and Quetiapine

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Adverse events
pharmacokinetic assessment

Estimated Enrollment:	12
Study Start Date:	October 2003

Detailed Description:

A placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. To assess the safety of IV cocaine in subjects taking quetiapine at 3 dosage levels.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Please contact site for further information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087750

Locations

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Domenic Ciraulo, M.D.

Boston University

More Information

Study ID Numbers:	NIDA-MDS-0001-1
Study First Received:	July 13, 2004
Last Updated:	February 8, 2007
ClinicalTrials.gov Identifier:	NCT00087750
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Quetiapine
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009