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ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

NCT ID: NCT00834080

Last Updated: 2018-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Detailed Description

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Conditions

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Opiate Dependence

Keywords

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opioid dependence VIVITROL opioid-related disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medisorb naltrexone 380 mg (VIVITROL)

Group Type EXPERIMENTAL

Medisorb naltrexone 380 mg

Intervention Type DRUG

Intramuscular (IM) injection administered once every 4 weeks for up to 2 years

Interventions

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Medisorb naltrexone 380 mg

Intramuscular (IM) injection administered once every 4 weeks for up to 2 years

Intervention Type DRUG

Other Intervention Names

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VIVITROL 380 mg Naltrexone for extended-release injectable suspension

Eligibility Criteria

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Inclusion Criteria

* Health care professional (eg, physician, osteopath, nurse, pharmacist)
* 18 years of age or older
* Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
* Women of childbearing potential must agree to use an approved method of contraception for the duration of the study

Exclusion Criteria

* Pregnancy and/or lactation
* Evidence of hepatic failure
* Active hepatitis
* Any psychiatric disorder that would compromise ability to complete study requirements
* Recent history of suicidal ideation or attempt
* Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
* Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alkermes Medical Director

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

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Alkermes Clinical Study Site

Colton, California, United States

Site Status

Alkermes Clinical Study Site

Oceanside, California, United States

Site Status

Alkermes Clinical Study Site

Lauderhill, Florida, United States

Site Status

Alkermes Clinical Study Site

Hoffman Estates, Illinois, United States

Site Status

Alkermes Clinical Study Site

St Louis, Missouri, United States

Site Status

Alkermes Clinical Study Site

Elmsford, New York, United States

Site Status

Alkermes Clinical Study Site

Canton, Ohio, United States

Site Status

Alkermes Clinical Study Site

Philadelphia, Pennsylvania, United States

Site Status

Alkermes Clinical Study Site

Philadelphia, Pennsylvania, United States

Site Status

Alkermes Clinical Study Site

Austin, Texas, United States

Site Status

Alkermes Clinical Study Site

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Earley PH, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence. J Addict Med. 2017 May/Jun;11(3):224-230. doi: 10.1097/ADM.0000000000000302.

Reference Type RESULT
PMID: 28358754 (View on PubMed)

Other Identifiers

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ALK21-021

Identifier Type: -

Identifier Source: org_study_id