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ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

NCT ID: NCT01218971

Last Updated: 2010-12-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-09-30

Brief Summary

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This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.

Detailed Description

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All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.

Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.

All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.

Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (\~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).

Conditions

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Alcohol Dependence

Keywords

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Alcohol Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Medisorb naltrexone 380 mg

Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.

Group Type EXPERIMENTAL

Medisorb naltrexone 380 mg

Intervention Type DRUG

naltrexone for extended-release injectable suspension

Medisorb naltrexone 190 mg

IM injection administered once every 4 weeks for up to 48 weeks.

Group Type EXPERIMENTAL

Medisorb naltrexone 190 mg

Intervention Type DRUG

naltrexone for extended-release injectable suspension

Interventions

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Medisorb naltrexone 190 mg

naltrexone for extended-release injectable suspension

Intervention Type DRUG

Medisorb naltrexone 380 mg

naltrexone for extended-release injectable suspension

Intervention Type DRUG

Other Intervention Names

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VIVITROL

Eligibility Criteria

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Inclusion Criteria

* Completed study drug treatment in Study ALK21-003 (base study \[NCT01218958\])
* Written informed consent for this extension study
* Stable address and telephone; reconfirmation of contact's address and phone
* Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation

Exclusion Criteria

* Positive urine drug screen for opioids at Visit 1
* Early termination of study drug in the base study
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Alkermes, Inc.

Principal Investigators

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Bernard L Silverman, MD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Other Identifiers

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ALK21-003-EXT

Identifier Type: -

Identifier Source: org_study_id