NCT00015249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 1997

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1998

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 12, 2017

Status Verified

June 1, 1998

Enrollment Period

1.2 years

First QC Date

April 18, 2001

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (2)

  • Percent prepulse inhibition

  • Cocaine assessment

Interventions

AmantadineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cocaine dependence. Male. Right handed. Negative urine for cocaine

You may not qualify if:

  • Positive urine for cocaine. History of head trauma. Significant medical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York MDRU

New York, New York, 10010, United States

Location

Related Publications (1)

  • CPDD, 98, 99 NIDA Research Monograph Series 179, 1998 Manuscript submitted..

    BACKGROUND

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • John Rotrosen, M.D.

    New York MDRU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

February 1, 1997

Primary Completion

April 1, 1998

Study Completion

May 1, 1998

Last Updated

January 12, 2017

Record last verified: 1998-06

Locations

US(1)