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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: | NCT00000291 |
Purpose
The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Labetalol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control |
| Official Title: | Effects of Labetalol on Human Cocaine Use |
| Estimated Enrollment: | 0 |
| Study Start Date: | October 1997 |
| Estimated Study Completion Date: | December 2001 |
The goal of this study was to investigate the safety and utility of labetalol an alpha and beta adrenergic block, for cocaine dependence in humans. A total of 12 subjects were enrolled in this double blind, placebo controlled outpatient study. After baseline measures are obtained, three experimental sessions were held at least 2 days apart. Subjects were administered a single low (100 mg) or high dose of labetalol (200mg) or placebo on each of 3 experimental sessions. The labetalol doses were given in ascending order and the placebo treatment were randomly inserted into the sequence. A single dose of smoked cocaine (0.4 mg/kg) was administered 2 hrs after labetalol or placebo treatment. During the sessions, several subjective, behavioral and physiological measures were obtained.
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male/Female ages 20-55. History of smoked or intravenous cocaine use on the average of at least once a week over a six month period. Current history of good health and normal EKG. 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) during the study.
Exclusion Criteria:
Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. Current dependence on alcohol or on durgs other than cocaine. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency within 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-09259-8, P50-09259-8 |
| Study First Received: | September 20, 1999 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000291 |
| Health Authority: | United States: Federal Government |
|
Labetalol Cocaine-Related Disorders Mental Disorders |
Substance-Related Disorders Disorders of Environmental Origin Cocaine |
|
Neurotransmitter Agents Sympatholytics Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents |
