NCT00000338

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

January 11, 2017

Status Verified

March 1, 1996

First QC Date

September 20, 1999

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (10)

  • 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

Interventions

LisurideDRUG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Lisuride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Walter Ling, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

March 1, 1996

Last Updated

January 11, 2017

Record last verified: 1996-03

Locations

US(1)