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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)

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE May 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2005)
  • Subjective effects
  • Physiological effects
  • Behavioral
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Physiological effects
  • Behavioral
  • Subjective effects
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effects of Phenytoin on Cocaine Use in Humans - 2
Official Title  ICMJE Effects of Phenytoin on Cocaine Use in Humans
Brief Summary The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Phenytoin
Study Arms  ICMJE Not Provided
Publications * Drug Alcohol Depend. 53:273-75, 1999. Manuscript in preparation.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00000285
Other Study ID Numbers  ICMJE NIDA-09259-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE University of Minnesota
Investigators  ICMJE
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP