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Effects of Labetalol on Human Cocaine Use - 8

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000291
First Posted: September 21, 1999
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by:
National Institute on Drug Abuse (NIDA)
  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 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Labetalol on Human Cocaine Use

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Subjective
  • Physiological measures

Estimated Enrollment: 0
Study Start Date: October 1997
Estimated Study Completion Date: December 2001
Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000291


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Pharmacol. Biochem. Behav (accepted). None

ClinicalTrials.gov Identifier: NCT00000291     History of Changes
Other Study ID Numbers: NIDA-09259-8
P50-09259-8
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: January 12, 2017
Last Verified: November 2016

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Labetalol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists