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

Opiate Dependence Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834080
• Other study ID #: ALK21-021
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: May 2012

Study information

• Verified date: November 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years

Locations

Country	Name	City	State
United States	Alkermes Clinical Study Site	Austin	Texas
United States	Alkermes Clinical Study Site	Canton	Ohio
United States	Alkermes Clinical Study Site	Colton	California
United States	Alkermes Clinical Study Site	Dallas	Texas
United States	Alkermes Clinical Study Site	Elmsford	New York
United States	Alkermes Clinical Study Site	Hoffman Estates	Illinois
United States	Alkermes Clinical Study Site	Lauderhill	Florida
United States	Alkermes Clinical Study Site	Oceanside	California
United States	Alkermes Clinical Study Site	Philadelphia	Pennsylvania
United States	Alkermes Clinical Study Site	Philadelphia	Pennsylvania
United States	Alkermes Clinical Study Site	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.00000000000003 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 years (Baseline to end of study)