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

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Clinical Study Site, Colton, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Primary 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

Primary 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

Treatment and study plan

Medisorb naltrexone 380 mg

Drug

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

Other names: VIVITROL 380 mg, Naltrexone for extended-release injectable suspension

Primary outcomes

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.

Time frame: 2 years (Baseline to end of study)

A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 3, 2009
Registry last updated: Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed