Expired Study
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New York, New York 10010


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

NIDA-5-0013-7


NCT ID:

NCT00015249


Secondary ID:

Y01-5-0013-7


Study Acronym:


Brief Title:

Prepulse Inhibition of Startle in Cocaine Dependence - 7


Official Title:

Prepulse Inhibition of Startle in Cocaine Dependence (Human)


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Double-Blind, Primary Purpose: Diagnostic


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:John Rotrosen, M.D.
Principal Investigator
New York MDRU

Study Dates

Start Date:February 1997
Completion Date:May 1998
Completion Type:Actual
Primary Completion Date:April 1998
Primary Completion Type:Actual
Verification Date:June 1998
Last Changed Date:January 11, 2017
First Received Date:April 18, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percent prepulse inhibition
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Cocaine assessment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Amantadine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)
Agency Class:Other
Agency Type:Collaborator
Agency Name:New York MDRU

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:CPDD, 98, 99 NIDA Research Monograph Series 179, 1998 Manuscript submitted..

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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