AlcoholismPhase 3NCT00156936
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
A Phase 3 study testing Medisorb naltrexone 380 mg and Oral naltrexone to Medisorb naltrexone 380 mg in people with Alcoholism and Opiate Dependence, run by Alkermes, Inc..
Trial summary
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Opiate Dependence
- What is being tested?
- Medisorb naltrexone 380 mg and Oral naltrexone to Medisorb naltrexone 380 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
- 108 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Jan 2007
- 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:
- Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study
- Willing and able to return for scheduled clinic visits and study assessments
- Had a stable address
- Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential
- Written informed consent
Primary Exclusion Criteria:
- Pregnancy or lactation
- Terminated early from study drug in a previous Medisorb naltrexone clinical trial
- Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
About this study
Official title: An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
Read the detailed description
From the date of successful completion of Study ALK21-006 (base study [NCT01218997])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.
- Conditions
- Alcoholism, Opiate Dependence
- Being tested
- Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg
- Medical subject headings
- Alcoholism, 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
Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
Oral naltrexone to Medisorb naltrexone 380 mgDrug
Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Not described Receives: Drug: Medisorb naltrexone 380 mg |
| Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Not described Receives: Drug: Oral naltrexone to Medisorb naltrexone 380 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Reported 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: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: Business decision
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT00156936
- Sponsor's protocol ID
- ALK21-006EXT
- Status last verified
- Nov 2010
- First submitted
- 7 Sep 2005
- Last updated
- 17 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone
- ClinicalTrials.gov ID
- NCT00156936
- Acronym / sponsor ID
- ALK21-006EXT
- Conditions
- Alcoholism, Opiate Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 3 Nov 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 multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
Detailed description
From the date of successful completion of Study ALK21-006 (base study [NCT01218997])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 to Medisorb naltrexone 380 mg (VIVITROL) | Experimental | Drug: Oral naltrexone to 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 suspensionAdministered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study. | Drug | Medisorb naltrexone 380 mg (VIVITROL) |
| Oral naltrexone to Medisorb naltrexone 380 mgSubjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks. | Drug | Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL) |
Primary outcome
Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
Time frame: Up to 3 years
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 17 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alcoholism
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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 to Medisorb naltrexone 380 mg in people with Alcoholism and Opiate Dependence, 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: stopped early, as of the sponsor's last update on 17 Nov 2010. 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 3 Nov 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 Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. (time frame: Up to 3 years). 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 17 Nov 2010.