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CompletedNCT02161718

Safety study of ALKS 3831 in schizophrenia

This study is completed in the United States, in Bulgaria, and in Poland. It is testing ALKS 3831 for schizophrenia.

Addiction, SchizophreniaDrugFrom 18 Years to 65 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether ALKS 3831 may be useful for adults experiencing addiction.

What would participation involve?

Participants may receive ALKS 3831, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Bulgaria, in Poland, and in the United States.

Who is it mainly for?

This study appears to be mainly for adults with addiction.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: May 2014
Recruitment status
Completed
Enrollment listed in the registry
300
Sponsor
Alkermes, Inc.
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Bulgaria, Poland
Age range
From 18 Years to 65 Years
Official registry ID
NCT02161718
Official title
A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Bulgaria · 9 sites
  • Alkermes Investigational Site
    Burgas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Kazanlak
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Lovech
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Novi Iskar
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Sofia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Tserova Koria
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Varna
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Varna
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Vratsa
    Site status: Not listed — confirm with the team
Poland · 4 sites
  • Alkermes Investigational Site
    Bełchatów
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Bialystok
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Gdansk
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Lublin
    Site status: Not listed — confirm with the team
United States · 58 sites
  • Alkermes Investigational Site
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Springdale, Arkansas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Anaheim, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Culver City, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Irvine, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    La Jolla, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    National City, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Oakland, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Orange, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    San Diego, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    San Francisco, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Torrance, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Washington D.C., District of Columbia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Fort Lauderdale, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Leesburg, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    North Miami, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Oakland Park, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Augusta, Georgia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Hoffman Estates, Illinois
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Worcester, Massachusetts
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Flowood, Mississippi
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Creve Coeur, Missouri
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Kansas City, Missouri
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Claremont, New Hampshire
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Nashua, New Hampshire
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Neptune City, New Jersey
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Cedarhurst, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Jamaica, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    New York, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    New York, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    New York, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Rochester, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Dayton, Ohio
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Scranton, Pennsylvania
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Charleston, South Carolina
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Charleston, South Carolina
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Charleston, South Carolina
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    DeSoto, Texas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Bellevue, Washington
    Site status: Not listed — confirm with the team

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Study ID: NCT02161718. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with addiction. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Are there criteria about substance use or wanting to reduce it?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Alkermes, Inc., which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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