Selegiline in Outpatient Treatment for Cocaine Dependence... | NCT00000336

Studies
Selegiline in Outpatient Treatment for Cocaine Dependence - 1

NCT00000336

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 16, 2017Estimated

Enrollment

Phase

Phase 2

Conditions

Cocaine-Related Disorders

Interventions

Selegiline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Y01-3-0010-1

Status Module

Record Verification Date

Jan 1996

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1995

Primary Completion Date

Feb 1996Actual

Completion Date

Mar 1996Actual

First Submitted Date

Sep 20, 1999

First Submission Date that Met QC Criteria

Sep 20, 1999

First Posted Date

Sep 21, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Selegiline	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter Ling, M.D.	Friends Research Institute, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friends Research Institute		Los Angeles	California	90025	United States

Condition Browse Module

MeSH Terms

ID	Term
D019970	Cocaine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012642	Selegiline

Ancestor Terms

ID	Term
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided