Infusion Laboratory: Protocol 2 (Lisuride) - 3

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000338

Purpose

The purpose of this study is to evaluate clinical safety issues pertaining to lisuride, to cocaine, and to its interaction in a chronic, crack dependent population, and to determine how pretreatment with lisuride modifies the subjective as well as physiological effects of cocaine.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Lisuride	Phase I

Drug Information available for: Lisuride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Infusion Laboratory: Protocol 2 (Lisuride)

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

Primary Outcome Measures:

Degree of drug craving
History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
Characterization of study population
Population incidence of symptoms of depression, po
Frequency and intensity of drug use and sexual beh
Evidence of change in neurophysiology and brain ac
Evidence of change in subjective responses to coca
Clinical physiological response to cocaine challen
Degree to which study medication influences change

Estimated Enrollment:	2
Study Start Date:	March 1996

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000338

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

Study ID Numbers:	NIDA-3-0010-3, Y01-3-0010-3
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000338
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Lisuride
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses

Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009