Back to resultsSelegiline in Outpatient Treatment for Cocaine Dependence - 1
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Selegiline
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
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.
Sites / Locations
- Friends Research Institute
Outcomes
Primary Outcome Measures
Urine toxicology for cocaine
Self reports of cocaine and other drug use and craving
Evidence of change in neurotoxicity based on choreoathetoid movement assessments
Secondary Outcome Measures
Full Information
NCT ID
NCT00000336
First Posted
September 20, 1999
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000336
Brief Title
Selegiline in Outpatient Treatment for Cocaine Dependence - 1
Official Title
Safety and Efficacy of Selegiline in Outpatient Treatment for Cocaine
Study Type
Interventional
2. Study Status
Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
February 1996 (Actual)
Study Completion Date
March 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Selegiline
Primary Outcome Measure Information:
Title
Urine toxicology for cocaine
Title
Self reports of cocaine and other drug use and craving
Title
Evidence of change in neurotoxicity based on choreoathetoid movement assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Selegiline in Outpatient Treatment for Cocaine Dependence - 1
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