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Important Information

Indivior does not direct or recommend the scope, objective, design, or operational conduct of an externally-sponsored study, proactively suggest future research or investigations, or solicit applications for support.

Indivior may provide support in the form of funding and/or product supply (i.e., study medication) for externally-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 Process Overview section.

For questions or additional information, please contact the Indivior Externally Sponsored Studies team at investigationalstudies@indivior.com

Important Information

All activities related to externally-sponsored study processes – from submission of the proposal to the close-out of a completed study – are managed through the program’s web portal unless otherwise directed by Indivior.

Should a proposal subsequently be endorsed to progress to the next stage of review, a full protocol will be requested and must then be submitted for continued review and consideration of the request.

Proposals must be submitted through the web portal.

  • Concept proposal submitted
  • Concept proposal reviewed and decision communicated
  • Full protocol and supporting documents submitted
  • Full protocol and supporting documents reviewed and decision communicated
  • Contract support agreement developed and executed
  • Support provided based on contracted milestones
  • Periodic study updates and ongoing safety reporting required
  • Provision of final study report after study completion
  • 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:

  • Investigator qualifications
  • Ability of the study investigator to conduct a high quality, ethical study
  • Research design and methodology that is objective, unbiased, balanced, and scientifically rigorous

Full disclosure must be made of any external funding that is being sought or that will be received, in addition to any support being requested from Indivior.

Previous support from Indivior does not guarantee future support. Each request for support is evaluated based on its merits and in consideration of funding availability.

Indivior will require additional documentation before providing support (i.e., funding and/or product supply). Examples include (some may be country-specific):

  • Curriculum vitae of all investigators
  • Institutional review board/ethics committee approved study protocol and informed consent form (if the final version of the protocol is materially different from the version of the protocol Indivior approved for support, Indivior reserves the right to reconsider providing support)
  • A budget which includes reasonable costs that are consistent with fair market value
  • Fully-executed signed contract
  • Facility license for controlled substances, if applicable

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

Indivior also requires that periodic study status updates be provided, and that the investigator/sponsor meets all safety reporting obligations as per the fully-executed signed contract.

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

An investigator/sponsor conducting an externally-sponsored study will be contractually required to provide Indivior with a written report of the final study results, return any unused funds, and ensure appropriate disposition of unused product supply as instructed by Indivior.

Study-related abstracts, manuscripts, and other similar documents must be provided to Indivior in advance of submission for intellectual property review in accordance with the fully-executed signed contract.

Areas of Research Interest

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

Indivior will consider providing funding and/or product supply for proposals/protocols that align with its areas of research interest.

Top view brain outline

SUBLOCADE®/SUBUTEX® Prolonged-release Injection

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

  1. Regarding the treatment of opioid use disorder with SUBLOCADE®/SUBUTEX® Prolonged-release Injection, 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 special populations, sub-populations, patients at risk, and underserved patients
  2. Support of scientific research (utilizing SUBLOCADE®/SUBUTEX® Prolonged-release Injection) 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
  3. Addressing unmet medical needs for patients with substance use disorders

SUBOXONE® (studies conducted outside of the United States only)

Indivior will consider providing funding and/or SUBOXONE® (buprenorphine and naloxone) sublingual film, for sublingual or buccal use, CIII for ESS proposals that align with its areas of research interest for studies conducted outside of the United States only.

  1. Regarding the treatment of opioid use disorder with SUBOXONE® sublingual film, these are:
    • Improving treatment adherence; preventing/reducing relapse and overdose
    • Evaluating long-term treatment outcomes (including real-world evidence, quality-of-life assessments, and health economic assessments)
    • Evaluation in sub-populations, patients at risk, and underserved patients
  2. Support of scientific research (utilizing SUBOXONE® sublingual film) 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
  3. Addressing unmet medical needs for patients with substance use disorders

SUBLOCADE® and SUBOXONE® (studies conducted within the United States)

Indivior will consider providing support for the following:

  1. Studies that meet at least one of the applicable ESS areas of research interest for SUBLOCADE®, AND in which SUBOXONE® sublingual film or a generic transmucosal buprenorphine/naloxone product is proposed to be used only in the manner as described in the SUBLOCADE® US Prescribing Information for the purpose of initiating SUBLOCADE® treatment following induction and dose-adjustment with a transmucosal buprenorphine-containing product, may be considered for support in the form of funding, or SUBLOCADE® and SUBOXONE® sublingual film, or both funding and SUBLOCADE®/SUBOXONE®. SUBOXONE® sublingual film alone will not be provided.
  2. Studies that meet at least one of the applicable ESS areas of research interest for SUBLOCADE® AND in which SUBOXONE® sublingual film or a generic transmucosal buprenorphine/naloxone product is proposed to be used in a manner other than as described in the SUBLOCADE® US Prescribing Information for the purpose of initiating SUBLOCADE® treatment following induction and dose-adjustment with a transmucosal buprenorphine-containing product may be considered for support in the form of SUBLOCADE® only.

Studies which support Substance Use Disorders research and which do not include the use of SUBLOCADE®/​SUBUTEX® Prolonged-release Injection, or SUBOXONE®

Indivior will consider providing funding only for ESS Program proposals that align with the following area of research interest:

  1. Addressing unmet medical needs for patients with substance use disorders
Blue blus sign with a dark blue atom-like shape in the background

OPVEE®

Indivior will consider providing funding and/or OPVEE® (nalmefene) nasal spray for ESS Program proposals that align with its current areas of research interest.

  1. Perspectives of patients and/or healthcare professionals on their lived experiences with OPVEE®; e.g., behavioral and social interventions post-reversal
  2. Comparative therapeutic efficacy/effectiveness (e.g., speed of onset, number of total doses required, total dose administered, total parenteral rescue dose administered) of OPVEE® to other opioid overdose treatment agents
  3. Adverse event profile following the administration of OPVEE® compared to naloxone
  4. Health-economic impact of opioid overdose
  5. Evaluation in special populations, sub-populations, individuals at risk, and underserved patients; e.g., criminal justice system population, unintentional opioid exposure in individuals without opioid use disorder (i.e., opioid poisoning), effectiveness of opioid antagonists in confirmed cases of polysubstance overdoses
  6. Impact of opioid-overdose treatment on the initiation of, and retention on, medications for the treatment of opioid use disorder
  7. Incidence of re-narcotization following opioid overdose treatment

Studies which support Overdose Reversal Science research, and which do not include the use of OPVEE®

Indivior will consider providing funding only for ESS Program proposals that align with the following areas of research interest.

  1. Health-economic impact of opioid overdose
  2. Evaluation in special populations, sub-populations, individuals at risk, and underserved patients; e.g., criminal justice system population, unintentional opioid exposure in individuals without opioid use disorder (i.e., opioid poisoning), effectiveness of opioid antagonists in confirmed cases of polysubstance overdoses
  3. Impact of opioid-overdose treatment on the initiation of, and retention on, medications for the treatment of opioid use disorder
  4. Incidence of re-narcotization following opioid overdose treatment
  5. Long-term outcomes or comorbidities associated with non-fatal opioid overdose; e.g., duration of hypoxia

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