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Important Information

Indivior may provide support in the form of funding and/or study medication for investigator sponsored studies that have gone through an internal review and approval process.

Before submitting a request for support, please review the information provided in the Submission Process section.

Please note that all required information must be included on the submission form prior to submitting it. It is not possible to save a partially completed form for completion at a later time.

For more information or questions, please contact the Indivior ISS team at investigationalstudies@indivior.com

Important Information

  • The request may be submitted either as a concept proposal or a full protocol
  • If a concept proposal is submitted and subsequently endorsed to progress to the next stage of review, a full protocol must then be submitted for continued review and consideration of the request

Requests must be submitted through this website

  • Submission through the website
  • Multi-stage review process
  • Supporting documents requested
  • Letter of agreement signed
  • Study updates
  • Ongoing safety reporting and funding/study medication reconciliation
  • Provision of final study report and/or study-related publication
  • Study closeout

In determining if support may be provided, Indivior will consider whether the request aligns with the Indivior areas of research interest. Other factors that will be considered include:

  • Scientific validity and rationale
  • Sponsor qualifications
  • Research methodology that is objective, unbiased, balanced, and scientifically rigorous
  • Ability of the study sponsor to conduct a high quality ethical study
  • Budget, including reasonable costs that are consistent with fair market value

If you are seeking external funding in addition to any support being requested from Indivior, full disclosure must be made.

Upon favorable review of the full protocol, Indivior will require additional documents before providing support (i.e. funding and/or study medication). Examples include (some may be country-specific):

  • Institutional review board/ethics committee approval
  • Full study protocol - if the final protocol is materially different from the approved protocol, Indivior reserves the right to reconsider providing support
  • Evidence that each investigator/sub-investigator has a current license to practice medicine, if applicable
  • Facility license for controlled substances, if applicable
  • Fully executed letter of agreement
  • Curriculum vitae of all investigators and sub-investigators
  • Form FDA 1572, if applicable

Indivior requires that funding and study medication be used solely for the study for which it was approved.

Indivior also requires that study status updates be provided and that the investigator meets all safety reporting obligations as per the letter of agreement.

It is the responsibility of the investigator to provide details of the registration of a clinical study with any required registry (e.g., ClinicalTrials.gov, EudraCT), as applicable.

An investigator conducting an ISS is contractually required to provide Indivior with a written report of the final study results and to return unused funds and ensure appropriate disposition of unused study medication as instructed by Indivior.

Materials (e.g., abstract/manuscript) that will be submitted for publication must be provided to Indivior in advance of the submission in accordance with the letter of agreement.

Areas of Research Interest

The information provided on this website regarding investigator sponsored studies is intended only for health care professionals, researchers, and scientists interested in submitting a study proposal to Indivior PLC or one of its subsidiaries (“Indivior”).

For studies that include the use of an Indivior medicinal product, only proposals from countries in which the product is marketed will be considered.

Indivior will consider providing funding and/or SUBLOCADE® (buprenorphine extended-release) injection for subcutaneous use (CIII) for ISS proposals that align with its areas of research interest.

  1. Regarding the treatment of opioid use disorder with SUBLOCADE, these are:
    • Improving treatment adherence; preventing/reducing relapse, overdose, and abuse/misuse/diversion
    • Evaluating long-term treatment outcomes (including real-world evidence, quality-of-life assessments, and health economic assessments)
    • Optimizing treatment/treatment strategies across the treatment continuum (i.e., initiation, maintenance, cessation)
    • Evaluation in sub-populations, patients at risk, and underserved patients
  2. Support of scientific research (utilizing SUBLOCADE) regarding substance use disorders (may include, but not limited to, opioid use disorder) to establish a proof of concept or to confirm mechanism of action

Indivior will consider providing funding and/or PERSERIS® (risperidone) for extended-release injectable suspension for subcutaneous use for ISS proposals that align with its areas of research interest.

  1. Expanding therapeutic options for the treatment of schizophrenia with PERSERIS
    • Improving treatment adherence
    • Assessing alternative dosing regimens; e.g., in the transition from orally-administered medication to PERSERIS
    • Reducing relapse/re-hospitalization
    • Reducing suicidal behavior
    • First-episode psychosis
    • Treatment initiation in the emergency department
    • Reduction in length of hospital stay
    • Continuity of care during the COVID-19 pandemic
  2. Developing PERSERIS treatment strategies with regard to:
    • Expanded treatment options for related psychotic disorders (e.g., schizoaffective disorder, schizophreniform disorder, substance-induced psychotic disorder)
    • Innovative treatment options for co-morbid and/or standalone substance use disorders; e.g., cannabis-induced psychosis, increased relapse risk secondary to cannabis use in individuals with psychosis, stimulant (e.g., cocaine, methamphetamine) use disorder
  3. Evaluating PERSERIS long-term treatment outcomes (including real-world evidence and quality-of-life assessments)
  4. Evaluating/optimizing PERSERIS treatment within the criminal justice system

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