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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Minnesota |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000285 |
Purpose
The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Phenytoin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Effects of Phenytoin on Cocaine Use in Humans |
| Estimated Enrollment: | 0 |
| Study Start Date: | May 1996 |
| Estimated Study Completion Date: | December 2001 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Dorothy Hatsukami, Ph.D. | University of Minnesota |
More Information
| Study ID Numbers: | NIDA-09259-2, P50-09259-2 |
| Study First Received: | September 20, 1999 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000285 |
| Health Authority: | United States: Federal Government |
|
Cocaine-Related Disorders Phenytoin Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Cocaine |
|
Therapeutic Uses Central Nervous System Agents Pharmacologic Actions Anticonvulsants |
