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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000336
Other study ID # NIDA-3-0010-1
Secondary ID Y01-3-0010-1
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated January 13, 2017
Start date January 1995
Est. completion date March 1996

Study information

Verified date January 1996
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 1996
Est. primary completion date February 1996
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Selegiline


Locations

Country Name City State
United States Friends Research Institute Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urine toxicology for cocaine
Primary Self reports of cocaine and other drug use and craving
Primary Evidence of change in neurotoxicity based on choreoathetoid movement assessments
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