Naltrexone in Treatment of Cocaine Dependence - 5 | NCT00015080

Studies
Naltrexone in Treatment of Cocaine Dependence - 5

NCT00015080

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 16, 2017Estimated

Enrollment

Phase

Phase 2

Conditions

Cocaine-Related Disorders

Interventions

Naltrexone

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
Y01-5-0012-5

Status Module

Record Verification Date

Dec 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

May 1995

Primary Completion Date

Jun 1996Actual

Completion Date

Jul 1996Actual

First Submitted Date

Apr 18, 2001

First Submission Date that Met QC Criteria

Apr 17, 2001

First Posted Date

Apr 18, 2001Estimated

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

Name	Class
Cincinnati MDRU	OTHER

Description Module

Brief Summary

The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Detailed Description

Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

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
Naltrexone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention
Cocaine use
Depression
Anxiety
Addiction severity
Global improvement
Psychopathology

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet DSM-III-R criteria for cocaine dependency,
18 to 65 years of age,
capable of understanding the study,
voluntarily signed consent,
male or non-pregnant female using approved form of birth control.

Exclusion Criteria:

abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
opioid use within the last 7 days,
use of neuroleptics,
having a severe acute medical problem,
unable to complete psychiatric rating scales, or
judged by the investigator to be unlikely to comply with the study protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eugene Somoza, M.D., Ph.D.	Cincinnati MDRU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati MDRU		Cincinnati	Ohio	45220	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Somoza, E., et al. A Double-Blind,Placebo Controlled Clinical Trial of Naltrexone as a Treatment for Cocaine Dependence. NIDA Research Monograph, 1998, 179, p. 295.. None

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

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571