Effects of Carvedilol on Cocaine Use in Humans - 11

Cocaine-Related Disorders Clinical Trial

Official title:

Effects of Carvedilol on Cocaine Use in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000294
• Other study ID #: NIDA-09259-11
• Secondary ID: P50-09259-11
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: September 1998
• Est. completion date: December 2001

Study information

• Verified date: March 1999
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine carvedilol effects in response to cocaine.

Description:

The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12 subjects were enrolled in this double blind, placebo controlled, outpatient study. After an adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3 experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or placebo were administered. Two hours following carvedilol or placebo treatment, subjects received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session, subjects had the option to earn up to 2 tokens by working on a computer task that could later be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic receptors by carvedilol would significantly alter the subjective and physiological effects of cocaine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

Male/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam)

Exclusion Criteria:

Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Carvedilol

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral
Primary	Subjective
Primary	Physiologic measures