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

Alkermes

Status and phase: Completed; Phase 3

Conditions: Opiate Dependence

Treatments: Drug: Medisorb naltrexone 380 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834080

ALK21-021

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Medisorb naltrexone 380 mg (VIVITROL)

Experimental group

Treatment:

Drug: Medisorb naltrexone 380 mg