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Effects of Labetalol on Human Cocaine Use - 8
This study has been completed.
Study NCT00000291   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 20, 1999   Last Updated: November 3, 2005   History of Changes

September 20, 1999
November 3, 2005
October 1997
 
  • Subjective
  • Physiological measures
Same as current
Complete list of historical versions of study NCT00000291 on ClinicalTrials.gov Archive Site
 
 
 
Effects of Labetalol on Human Cocaine Use - 8
Effects of Labetalol on Human Cocaine Use

The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.

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.

Phase II
Interventional
Treatment, Double-Blind, Placebo Control
Cocaine-Related Disorders
Drug: Labetalol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
0
December 2001
 

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.

Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000291
 
NIDA-09259-8, P50-09259-8
National Institute on Drug Abuse (NIDA)
University of Minnesota
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
National Institute on Drug Abuse (NIDA)
August 1998

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