Effects of Labetalol on Human Cocaine Use - 8

This study has been completed.

First Received: September 20, 1999 Last Updated: November 3, 2005 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	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

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Labetalol hydrochloride Labetalol Dilevalol

U.S. FDA Resources

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

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators

Principal Investigator:

Dorothy Hatsukami, Ph.D.

University of Minnesota

More Information

No publications provided

Study ID Numbers:	NIDA-09259-8, P50-09259-8
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000291 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Sympatholytics
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Labetalol
Autonomic Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009