Effects of Labetalol on Human Cocaine Use - 8
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders
Intervention: Labetalol (Drug)
Phase: Phase 2
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
Dorothy Hatsukami, Ph.D., Principal Investigator, Affiliation: University of Minnesota
The purpose of this study is to determine the effect of labetalol treatment on the subjective
and physiological effects of cocaine.
Official title: Effects of Labetalol on Human Cocaine Use
Study design: Treatment, Double-Blind, Placebo Control
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.
Minimum age: 20 Years.
Maximum age: 45 Years.
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
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.
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55455, United States
Starting date: October 1997
Ending date: December 2001
Last updated: November 3, 2005