AlcoholismPhase 3NCT01218997
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
A Phase 3 study testing Medisorb naltrexone 380 mg and Oral naltrexone 50 mg in people with Alcoholism, run by Alkermes, Inc..
Trial summary
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Medisorb naltrexone 380 mg and Oral naltrexone 50 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Mar 2005
- 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:
- Current diagnosis of DSM-IV alcohol dependence and/or diagnosis of DSM-IV opiate dependence within 3 months prior to screening
- 18 years or older
- Desire to seek treatment for alcohol and/or opiate abuse/dependence
- Agree to use contraception for the study duration if of childbearing potential
- Written informed consent and willingness to perform study procedures
- Stable address and phone and at least 1 source of contact information (eg, family member, significant other)
Primary Exclusion Criteria:
- Presence of opiates in the urine (as determined by urine drug test) on Day 0 prior to naltrexone treatment
- Clinically significant medical/psychological condition or abnormality at screening (ie, physical examination, electrocardiogram [ECG], hematology or blood chemistry evaluation, or urinalysis findings)
- Clinically significant active hepatitis or hepatic failure evidenced by 1 of the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 3 times the upper limit of normal (3xULN), hyperbilirubinemia (bilirubin >10% above ULN), creatine phosphokinase (CPK) higher than 10xULN, prolonged prothrombin time(international normalized ratio ≥1.7), ascites, or esophageal variceal disease
- Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric disorders that would compromise ability to complete the study
- Participation in a formal methadone program currently or within prior 3 years
- More than 2 prior medically supervised detoxification treatments in prior 3 years
- Pregnancy or lactation
- Current prescribed opiate therapy, or receipt of opiates within 7 days prior to study drug dosing, or ongoing medical condition likely to require prescribed opiate therapy during study period
- Failed naloxone challenge on Day 0 (the challenge could be repeated up to 2 times, with at least 24 hours between attempts)
- Participation in a clinical trial within 30 days of screening
- Previous enrollment in a VIVITROL clinical trial
- Receipt of any drug product administered as a gluteal injection within 180 days prior to Day 0 or anticipated need for gluteal injections during study period
- Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG)
About this study
Official title: A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.
Read the detailed description
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).
All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.
- Conditions
- Alcoholism
- Being tested
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- Keywords
- Alcoholism, Alcohol dependence
- Medical subject headings
- Alcoholism
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
Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
Oral naltrexone 50 mgDrug
Also called Revia®
Tablet taken orally once daily for up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Not described Receives: Drug: Medisorb naltrexone 380 mg |
| Oral naltrexone 50 mg | Active comparator | Not described Receives: Drug: Oral naltrexone 50 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 was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2003
- Primary completionMar 2005
- Study completionMar 2005
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.
- Other trials for AlcoholismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard L. Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218997
- Sponsor's protocol ID
- ALK21-006
- Status last verified
- Dec 2010
- First submitted
- 8 Oct 2010
- Last updated
- 4 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone
- ClinicalTrials.gov ID
- NCT01218997
- Acronym / sponsor ID
- ALK21-006
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Alcohol dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 13 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.
Detailed description
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).
All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Drug: Medisorb naltrexone 380 mg |
| Oral naltrexone 50 mg | Active comparator | Drug: Oral naltrexone 50 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 suspensionAdministered via intramuscular (IM) injection once every 4 weeks for up to 1 year. | Drug | Medisorb naltrexone 380 mg (VIVITROL) |
| Oral naltrexone 50 mgAlso: Revia®Tablet taken orally once daily for up to 1 year | Drug | Oral naltrexone 50 mg |
Primary outcome
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study
Time frame: up to 1 year
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bernard L. Silverman, MD study director
Alkermes, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medisorb naltrexone 380 mg and Oral naltrexone 50 mg in people with Alcoholism, run by Alkermes, Inc..
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 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 13 Dec 2010). 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: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2011.