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

Phase 3

Completed

• Conditions: Opiate Dependence
• Interventions: Drug: Medisorb naltrexone 380 mg

• Registration Number: NCT00834080
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Start: 2009-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-05-30
• Results First Submitted QC: 2013-05-30
• Results First Posted: 2013-07-29
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medisorb naltrexone 380 mg (VIVITROL)	Medisorb naltrexone 380 mg	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alkermes Clinical Study Site; 🇺🇸 Dallas, Texas, United States