Infusion Laboratory: Protocol 2 (Lisuride) - 3 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 16, 2005

Start Date ^ICMJE

March 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Infusion Laboratory: Protocol 2 (Lisuride) - 3

Official Title ^ICMJE

Infusion Laboratory: Protocol 2 (Lisuride)

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Lisuride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000338

Responsible Party

Study ID Numbers ^ICMJE

NIDA-3-0010-3, Y01-3-0010-3

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 1996

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP