Opiate DependencePhase 3NCT00834080
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
A Phase 3 study testing Medisorb naltrexone 380 mg in people with Opiate Dependence, run by Alkermes, Inc. at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Medisorb naltrexone 380 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2009to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Alkermes Clinical Study Site
Austin, Texas, 78754
Alkermes Clinical Study Site
Canton, Ohio, 44718
Alkermes Clinical Study Site
Colton, California, 92324
Alkermes Clinical Study Site
Dallas, Texas, 75225
Alkermes Clinical Study Site
Elmsford, New York, 10523
Alkermes Clinical Study Site
Hoffman Estates, Illinois, 60194
Alkermes Clinical Study Site
Lauderhill, Florida, 33319
Alkermes Clinical Study Site
Oceanside, California, 92056
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, 19118
Alkermes Clinical Study Site
Philadelphia, Pennsylvania, 19125
Alkermes Clinical Study Site
St Louis, Missouri, 63109
About this study
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
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.
- Conditions
- Opiate Dependence
- Being tested
- Medisorb naltrexone 380 mg
- Keywords
- opioid dependence, VIVITROL, opioid-related disorders
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medisorb naltrexone 380 mgDrug
Also called VIVITROL 380 mg, Naltrexone for extended-release injectable suspension
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Not described Receives: Drug: Medisorb naltrexone 380 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years (Baseline to end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alkermes Medical Director, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834080
- Sponsor's protocol ID
- ALK21-021
- Status last verified
- Nov 2018
- First submitted
- 2 Feb 2009
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28358754
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00834080
- Acronym / sponsor ID
- ALK21-021
- Conditions
- Opiate Dependence
- Keywords
- opioid dependence, VIVITROL, opioid-related disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 29 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Drug: Medisorb naltrexone 380 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medisorb naltrexone 380 mgAlso: VIVITROL 380 mg, Naltrexone for extended-release injectable suspensionIntramuscular (IM) injection administered once every 4 weeks for up to 2 years | Drug | Medisorb naltrexone 380 mg (VIVITROL) |
Primary outcome
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28358754Earley 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.
Related trials for Opiate Dependence
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
RecruitingPhase 1
MethaLoad Dose-Finding Study
Opioid Use Disorder (OUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alkermes Medical Director study director
Alkermes, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medisorb naltrexone 380 mg in people with Opiate Dependence, run by Alkermes, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. (time frame: 2 years (Baseline to end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.