NCT00000337

Brief Summary

The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 1994

Completed
4.9 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 12, 2017

Status Verified

August 1, 1996

First QC Date

September 20, 1999

Last Update Submit

January 11, 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

  • Population incidence of symptoms of depression, possible organic brain syndrome deficits

  • Frequency and intensity of drug use and sexual behaviors at risk for HIV

  • Evidence of change in neurophysiology and brain activity

  • Evidence of change in subjective responses to cocaine challenge

  • Clinical physiological response to cocaine challenge - especially adverse effects measures

  • Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)

  • Characterization of study population

Interventions

SelegilineDRUG

Eligibility Criteria

Age31 Years - 47 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

Related Publications (1)

  • 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal.". 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal."

    BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Walter Ling, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

November 1, 1994

Last Updated

January 12, 2017

Record last verified: 1996-08

Locations

US(1)