Back to resultsBrain Imaging: Cocaine Effects & Medication Development - 5
Primary Purpose
Cocaine-Related Disorders
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cocaine
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine
Eligibility Criteria
Please contact site for information.
Sites / Locations
- New York State Psychiatric Institute
Outcomes
Primary Outcome Measures
Absolute change in rCBF at 5 & 15 minutes (Xe)
Relative change in rCBF at 5, 19, & 33 minutes (O15)
Correlated with a) subjective effects, b) venous blood level of coca, c) autonomic variables
Secondary Outcome Measures
Full Information
NCT ID
NCT00000270
First Posted
September 20, 1999
Last Updated
August 1, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000270
Brief Title
Brain Imaging: Cocaine Effects & Medication Development - 5
Official Title
Brain Imaging: Cocaine Effects & Medication Development
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study never opened; never enrolled participants
Study Start Date
December 30, 1995 (Actual)
Primary Completion Date
December 30, 1995 (Actual)
Study Completion Date
December 30, 1995 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to define temporal profile of brain activation (rCBF) using Xenon-SPECT and O 15-PET.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cocaine
Primary Outcome Measure Information:
Title
Absolute change in rCBF at 5 & 15 minutes (Xe)
Title
Relative change in rCBF at 5, 19, & 33 minutes (O15)
Title
Correlated with a) subjective effects, b) venous blood level of coca, c) autonomic variables
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Kleber, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
Citation
ACNP Abstract, 1995. CPDD Abstract, 1996. Society for Nuclear Medicine, 1996. Society for Neuroscience, 1997.
Results Reference
background
Learn more about this trial
Brain Imaging: Cocaine Effects & Medication Development - 5
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