Research & Development

Investigator Initiated Trials (IIT)

Through our Investigator Initiated Trials (IIT) program, Alkermes supports investigator sponsored research on VIVITROL^® (naltrexone for extended-release injectable suspension).

In an IIT, the investigator, as the study sponsor, assumes responsibility for all aspects of the research, including:

• Study design
• Ensuring appropriate institutional, regulatory and ethics committee approval
• Study conduct, including responsibility for ensuring appropriate medical safeguards, adequate record keeping, medical monitoring, adverse event reporting and medical supervision
• Analysis, interpretation and communication of the results (e.g., publications and submissions to conferences and journals after review by Alkermes)

Investigators who are awarded support through Alkermes’ IIT program will be required to submit a final study report/summary to Alkermes at the conclusion of the study.

Alkermes is currently prioritizing review of projects which request a supply of VIVITROL and/or placebo for VIVITROL. If you are an investigator looking to submit a project proposal requesting VIVITROL and/or placebo for VIVITROL, please email IIT@Alkermes.com for an application. Please note that a submission of proposal does not guarantee Alkermes support.