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

Alkermes, Inc.38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opiate Dependence

Interventions

Medisorb naltrexone 380 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Alkermes Clinical Study Site

Colton, California, United States

Alkermes Clinical Study Site

Oceanside, California, United States

Alkermes Clinical Study Site

Lauderhill, Florida, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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