Back to resultsInteraction Between Cocaine and Quetiapine - 1
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility 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
Sites / Locations
- Boston University Medical Center
Outcomes
Primary Outcome Measures
Adverse events
pharmacokinetic assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00087750
First Posted
July 13, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00087750
Brief Title
Interaction Between Cocaine and Quetiapine - 1
Official Title
Interaction Between IV Cocaine and Quetiapine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Primary Outcome Measure Information:
Title
Adverse events
Title
pharmacokinetic assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenic Ciraulo, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interaction Between Cocaine and Quetiapine - 1
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