NCT00000285

Brief Summary

The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1996

Longer than P75 for phase_1

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

May 1, 1996

Completed
3.4 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
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

November 1, 2016

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (3)

  • Subjective effects

  • Physiological effects

  • Behavioral

Interventions

PhenytoinDRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males/Females between the ages of 20-40. History of smoked cocaine use on the avg. of at least 2 times/week over a 6 month period. Have currently used at least 1 g of cocaine within a 4-6 hr period. Current history of good health, normal serum albumin levels and normal QTc intervals. Nonreactive for HIV. No participation in any of our studies for the past 6 months. For females: not pregnant as determined by pregnancy screening nor breat feeding, and using acceptable birth control methods (e.g. birth control pills, diaphragm, condoms plus foam).

You may not qualify if:

  • History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other durgs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treated for chemical dependency within the past 6 months. Use of any psychotropic drugs including MAOIs in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Drug Alcohol Depend. 53:273-75, 1999. Manuscript in preparation.

    BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dorothy Hatsukami, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

May 1, 1996

Study Completion

December 1, 2001

Last Updated

January 12, 2017

Record last verified: 2016-11

Locations

US(1)