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

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Medisorb naltrexone 380 mg
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring opioid dependence, VIVITROL, opioid-related disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site
  • Alkermes Clinical Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medisorb naltrexone 380 mg (VIVITROL)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 2, 2009
Last Updated
November 15, 2018
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00834080
Brief Title
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opioid dependence, VIVITROL, opioid-related disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medisorb naltrexone 380 mg (VIVITROL)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Medisorb naltrexone 380 mg
Other Intervention Name(s)
VIVITROL 380 mg, Naltrexone for extended-release injectable suspension
Intervention Description
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkermes Medical Director
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Clinical Study Site
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19125
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Alkermes Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28358754
Citation
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.0000000000000302.
Results Reference
result

Learn more about this trial

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

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