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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
University of Minnesota |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000290 |
Purpose
The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Cocaine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control, Crossover Assignment |
| Official Title: | Stress Hormones and Human Cocaine Use |
| Estimated Enrollment: | 0 |
| Study Start Date: | May 1997 |
| Estimated Study Completion Date: | December 2001 |
The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG.
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 drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. 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-09259-7, P50-09259-7 |
| Study First Received: | September 20, 1999 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000290 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cocaine-Related Disorders Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Cardiovascular Agents Anesthetics, Local |
Pharmacologic Actions Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine Central Nervous System Agents |
