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Effects of Phenytoin on Cocaine Use in Humans - 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000285
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
University of Minnesota
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Phenytoin on Cocaine Use in Humans
Study Start Date : May 1996
Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Subjective effects
  2. Physiological effects
  3. Behavioral

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000285

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Minnesota
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Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
Drug Alcohol Depend. 53:273-75, 1999. Manuscript in preparation.

Layout table for additonal information Identifier: NCT00000285    
Other Study ID Numbers: NIDA-09259-2
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: November 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers