NCT00000198

Brief Summary

The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine dependent subjects maintained on piracetam while they are residing in an inpatient addictions treatment research unit and to subsequently follow these patients in an eight week open label assessment of piracetam in an outpatient treatment program.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1996

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

October 1, 1996

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

October 6, 2015

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

September 20, 1999

Last Update Submit

October 5, 2015

Conditions

Cocaine-Related Disorders

Keywords

cocaine

Outcome Measures

Primary Outcomes (3)

  • Pulse, blood pressure

  • Adverse effects

  • High, anxiety, withdrawal

Interventions

PiracetamDRUG

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Piracetam

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kyle Kampman, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1996

Primary Completion

October 1, 1997

Study Completion

October 1, 1997

Last Updated

October 6, 2015

Record last verified: 2013-12

Locations

US(1)