Prepulse Inhibition of Startle in Cocaine Dependence - 7
Primary Purpose
Cocaine-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amantadine
Sponsored by
About this trial
This is an interventional diagnostic trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Cocaine dependence. Male. Right handed. Negative urine for cocaine Exclusion Criteria: Positive urine for cocaine. History of head trauma. Significant medical disease.
Sites / Locations
- New York MDRU
Outcomes
Primary Outcome Measures
Percent prepulse inhibition
Cocaine assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00015249
First Posted
April 18, 2001
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
1. Study Identification
Unique Protocol Identification Number
NCT00015249
Brief Title
Prepulse Inhibition of Startle in Cocaine Dependence - 7
Official Title
Prepulse Inhibition of Startle in Cocaine Dependence (Human)
Study Type
Interventional
2. Study Status
Record Verification Date
June 1998
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
April 1998 (Actual)
Study Completion Date
May 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.
Detailed Description
The objective of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amantadine
Primary Outcome Measure Information:
Title
Percent prepulse inhibition
Title
Cocaine assessment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cocaine dependence. Male. Right handed. Negative urine for cocaine
Exclusion Criteria:
Positive urine for cocaine. History of head trauma. Significant medical disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rotrosen, M.D.
Organizational Affiliation
New York MDRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York MDRU
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Citations:
Citation
CPDD, 98, 99 NIDA Research Monograph Series 179, 1998 Manuscript submitted..
Results Reference
background
Learn more about this trial
Prepulse Inhibition of Startle in Cocaine Dependence - 7
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