Investigator Initiated Trials

Investigator Initiated Trials (IIT)

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Alkermes seeks to support investigator research designed and conducted by independent physicians and scientists. Alkermes has supported more than 40 clinical trials since the beginning of the IIT program in 2008. Alkermes can provide VIVITROL®, ARISTADA® and/or placebo to the IIT programs it supports. In addition, there may be limited financial support available. In general, the research we support is based in the U.S. with experienced researchers who have an established history of successfully receiving independent funding.

Areas of Interest

Substance Use Disorders

  • VIVITROL use in Special Populations:
    • Young Adults
    • Perinatal women
    • Older adults
    • Early/Late stage illness
    • Criminal Justice
    • Cannabis Use
  • Technology-based interventions to support the effectiveness of medication-assisted treatment
  • Cognitive effects of opioid agonists and antagonists

Schizophrenia

  • Integration of Long-Acting Injectables (LAIs) into psychosocial strategies
  • Patient/Family or Clinician engagement strategies in LAI use
  • Demonstration of LAI benefits in special populations
  • Criminal justice
  • Schizophrenia with substance use disorder
  • ARISTADA use in early stages of illness
  • Patients transitioning across treatment services

IIT applications are reviewed by a cross functional team of medical and scientific staff to consider patient safety, operational feasibility, scientific merit, and alignment with Alkermes research goals and needs. Applications can be submitted in one of two ways:

  • A pre-protocol submission where your application will serve as your proposal, but you have not developed a protocol yet; or
  • A protocol submission where your protocol is already developed and ready for review. To complete an application, please login here.

Please be aware that Alkermes cannot guarantee support for IIT program applications and all decisions regarding such support will be made at Alkermes’ sole discretion.

Application Submission Cut-Off Date Quarterly Meeting Review
September 15 Q4
December 15 Q1
March 15 Q2
June 15 Q3