Effects of Phenytoin on Cocaine Use in Humans - 2

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000285

Collaborator

University of Minnesota (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders	Drug: Phenytoin	Phase 1

Detailed Description

The purpose of this study was to determine the effects of phenytoin on smoked cocaine-base self-administration using our laboratory self-administration model. A total of 12 patients randomized, 6 to phenytoin and 6 to placebo treatment group. There were 2 phases in this 10-day inpatient study. Phase 1 subjects underwent one cocaine self-admin session. Randomization took place at the start of Phase 2, Day 4 where subjects received either placebo or phenytoin. The subjects assigned to phenytoin treatment received an oral loading dose (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/L). During Phase 2, subjects had the opportunity to self-administer cocaine on Days 5, 7, and 9. The plasma phenytoin levels were expected to decrease gradually during Phase 2 which provided an opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine self-administration.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Effects of Phenytoin on Cocaine Use in Humans

Study Start Date :

May 1, 1996

Study Completion Date :

Dec 1, 2001

Outcome Measures

Primary Outcome Measures

Subjective effects []
Physiological effects []
Behavioral []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)
University of Minnesota

Investigators

Principal Investigator: Dorothy Hatsukami, Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

Sofuoglu M, Pentel PR, Bliss RL, Goldman AI, Hatsukami DK. Effects of phenytoin on cocaine self-administration in humans. Drug Alcohol Depend. 1999 Feb 1;53(3):273-5.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00000285

Other Study ID Numbers:

NIDA-09259-2
P50-09259-2

First Posted:

Sep 21, 1999

Last Update Posted:

Jan 12, 2017

Last Verified:

Nov 1, 2016

Keywords provided by , ,

cocaine dependence

Additional relevant MeSH terms:

Cocaine-Related Disorders

Phenytoin

Study Results

No Results Posted as of Jan 12, 2017