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Completed

NCT Number: NCT00156923

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

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®).

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Medisorb naltrexone 380 mg

Drug

Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.

Other names: VIVITROL® 380 mg, Naltrexone for extended-release injectable suspension

Medisorb naltrexone 190 mg

Drug

Administered via IM injection once every 4 weeks for up to 3.5 years.

Other names: Naltrexone for extended-release injectable suspension

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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