AlcoholismPhase 3NCT00156923

ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

A Phase 3 study testing Medisorb naltrexone 380 mg and Medisorb naltrexone 190 mg in people with Alcoholism, run by Alkermes, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®). 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 Medisorb naltrexone 190 mg
Type of treatment: 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: Oct 2003to 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:

Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
Willing and able to return for scheduled clinic visits and study assessments
Noncustodial, stable address and phone
Written, informed consent

Primary Exclusion Criteria:

Pregnancy or lactation
Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

About this study

Official title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Read the detailed description

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Conditions: Alcoholism
Being tested: Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg
Keywords: 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 3.5 years.
Medisorb naltrexone 190 mgDrug
Also called Naltrexone for extended-release injectable suspension
Administered via IM injection once every 4 weeks for up to 3.5 years.

Study groups in NCT00156923
Study group	Role	What they receive
Medisorb naltrexone 380 mg	Experimental	Not described Receives: Drug: Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg	Experimental	Not described Receives: Drug: Medisorb naltrexone 190 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
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 in this extension through the end of the follow-up period).
Measured: Up to 3.5 years of monthly treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Jan 2007

First posted12 Sep 2005 (estimated)
Study startOct 2003
Primary completionJan 2007
Study completionJan 2007

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 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00156923
Sponsor's protocol ID: ALK21-010
Status last verified: Jun 2017
First submitted: 7 Sep 2005
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

O'Brien CP, Gastfriend DR, Forman RF, Schweizer E, Pettinati HM. Long-term opioid blockade and hedonic response: preliminary data from two open-label extension studies with extended-release naltrexone. Am J Addict. 2011 Mar-Apr;20(2):106-12. doi: 10.1111/j.1521-0391.2010.00107.x. Epub 2010 Dec 28.
PubMed 21314752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Alcoholism trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
ClinicalTrials.gov ID: NCT00156923
Acronym / sponsor ID: ALK21-010
Conditions: Alcoholism
Keywords: Alcohol dependence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2003
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 3 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, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Detailed description

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	Experimental	Drug: Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg	Experimental	Drug: Medisorb naltrexone 190 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 3.5 years.	Drug	Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mgAlso: Naltrexone for extended-release injectable suspensionAdministered via IM injection once every 4 weeks for up to 3.5 years.	Drug	Medisorb naltrexone 190 mg

Primary outcome

Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
Time frame: Up to 3.5 years of monthly treatment
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 in this extension through the end of the follow-up period).

Results and safety

Results posted to the registry on 3 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medisorb Naltrexone 380 mg	56	22
Medisorb Naltrexone 190 mg	52	20

Primary outcome: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)

Time frame: Up to 3.5 years of monthly treatment. Number. Unit: Participants

Measure	Medisorb Naltrexone 380 mg n = 56	Medisorb Naltrexone 190 mg n = 52
Value	49	51

Population analysed: Subjects who received at least 1 injection of study drug were included in the safety analyses

Adverse events

Time frame: Not including the base study (Study ALK21-003 [NCT01218958]) or the first extension (Study ALK21-003EXT [NCT01218971]), the maximum exposure to study drug and safety monitoring in subjects completing this second extension was approximately 3.5 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medisorb Naltrexone 380 mg	9 of 56 (16.1%)	51 of 56 (91.1%)	Not reported
Medisorb Naltrexone 190 mg	9 of 52 (17.3%)	49 of 52 (94.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21314752O'Brien CP, Gastfriend DR, Forman RF, Schweizer E, Pettinati HM. Long-term opioid blockade and hedonic response: preliminary data from two open-label extension studies with extended-release naltrexone. Am J Addict. 2011 Mar-Apr;20(2):106-12. doi: 10.1111/j.1521-0391.2010.00107.x. Epub 2010 Dec 28.
WHO International Clinical Trials registry platform search portalLink provided by the sponsor.

Related trials for Alcoholism

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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RecruitingPhase 1
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RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
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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 Medisorb naltrexone 190 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 11 Jul 2017. 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 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 Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) (time frame: Up to 3.5 years of monthly treatment). 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 NCT00156923, 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 Jul 2017.