Dose Response Trial of Pergolide for Cocaine Dependence - 1 | NCT00000248

Studies
Dose Response Trial of Pergolide for Cocaine Dependence - 1

NCT00000248

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

May 16, 2018Actual

Enrollment

Phase

Phase 3

Conditions

Cocaine-Related Disorders

Interventions

Pergolide

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
R01DA008355	U.S. NIH Grant/Contract		View source
R01-08355-1

Status Module

Record Verification Date

May 1997

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

Feb 1996

Primary Completion Date

Not provided

Completion Date

Not provided

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

May 15, 2018

Last Update Posted Date

May 16, 2018Actual

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

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 3

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
Pergolide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Side effects
Drug use
Retention
Cocaine withdrawal
Compliance
Effectiveness of medication for global improvements

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Please contact site for information.

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
Robert Malcolm, M.D.	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425 742	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9134073	Background	Malcolm R, Moore JW, Kajdasz DK, Cochrane CE. Pergolide mesylate. Adverse events occurring in the treatment of cocaine dependence. Am J Addict. 1997 Spring;6(2):117-23. doi: 10.3109/10550499709137022.

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

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds