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Effects of Carvedilol on Cocaine Use in Humans - 11

Effects of Carvedilol on Cocaine Use in Humans

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000294
Enrollment
0
Registered
1999-09-21
Start date
1998-09-30
Completion date
2001-12-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Brief summary

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

Detailed 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.

Interventions

DRUGCarvedilol

Sponsors

University of Minnesota
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Behavioral
Subjective
Physiologic measures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026