Prepulse Inhibition of Startle in Cocaine Dependence - 7 | NCT00015249

Studies
Prepulse Inhibition of Startle in Cocaine Dependence - 7

NCT00015249

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

Phase

Phase 1

Conditions

Cocaine-Related Disorders
Substance-Related Disorders

Interventions

Amantadine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Y01-5-0013-7

Status Module

Record Verification Date

Jun 1998

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1997

Primary Completion Date

Apr 1998Actual

Completion Date

May 1998Actual

First Submitted Date

Apr 18, 2001

First Submission Date that Met QC Criteria

Apr 17, 2001

First Posted Date

Apr 18, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
New York MDRU	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Rotrosen, M.D.	New York MDRU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York MDRU		New York	New York	10010	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	CPDD, 98, 99 NIDA Research Monograph Series 179, 1998 Manuscript submitted..

Measure	Description	Time Frame
Percent prepulse inhibition
Cocaine assessment

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

ID	Term
D019970	Cocaine-Related Disorders
D019966	Substance-Related Disorders