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