NCT00000336

Brief Summary

The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging, MRI) post-hoc as a possible variable for future stratification in clinical trials.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1995

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1996

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

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 16, 2017

Status Verified

January 1, 1996

Enrollment Period

1.1 years

First QC Date

September 20, 1999

Last Update Submit

January 13, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (3)

  • Urine toxicology for cocaine

  • Self reports of cocaine and other drug use and craving

  • Evidence of change in neurotoxicity based on choreoathetoid movement assessments

Interventions

SelegilineDRUG

Eligibility Criteria

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

You may qualify if:

  • M/F ages 21-50. Meets DSM-IV criteria for cocaine. Agreeable to conditions of study and signed informed consent.

You may not qualify if:

  • Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions 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

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 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

January 1, 1995

Primary Completion

February 1, 1996

Study Completion

March 1, 1996

Last Updated

January 16, 2017

Record last verified: 1996-01

Locations

US(1)