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.

Study Overview

• Status: Completed
• Conditions: Cocaine-Related Disorders
• Intervention / Treatment: Drug: Labetalol

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subjective
Physiological measures

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: University of Minnesota

Publications and helpful links

General Publications

• Pharmacol. Biochem. Behav (accepted). None

Study record dates

Study Major Dates

• Study Start: October 1, 1997
• Primary Completion: December 7, 2022
• Study Completion: December 1, 2001

Study Registration Dates

• First Submitted: September 20, 1999
• First Submitted That Met QC Criteria: September 20, 1999
• First Posted (Estimate): September 21, 1999

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: cocaine dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Labetalol
• Other Study ID Numbers: NIDA-09259-8; P50-09259-8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No