INDV-2000 fMRI study

  • Research type

    Research Study

  • Full title

    Randomised, placebo-controlled functional evaluation of INDV-2000 effects on cue reactivity in opiate dependence: An fMRI study.

  • IRAS ID

    1009658

  • Contact name

    Frank Gray

  • Contact email

    frank.gray@indivior.com

  • Sponsor organisation

    Indivior Inc.

  • ISRCTN Number

    ISRCTN15079632

  • Research summary

    The study medicine (INDV-2000) is an experimental medicine for treating opioid use disorder (OUD). Severe OUD is a chronic disorder also referred to as opioid addiction. People with OUD may have physical dependence (where withdrawal can cause symptoms such as aches, pains, and nausea) and psychological dependence (where withdrawal can cause symptoms such as strong cravings for the opioid or affect behaviour and have difficulty thinking about anything else).

    We hope INDV-2000 will help treat opioid addiction by binding to proteins in the brain called orexin-1 (OX1R) receptors, and reduce craving, relapse, and symptoms of withdrawal.

    We’ll test single doses of INDV-2000 in 36 opioid-dependent men and women (aged 18–65 years) who are taking a stable dose of methadone.

    We aim to find out:
    * if INDV-2000 affects the brain’s response to heroin-related cues in participants with opioid addiction. To find out, we’ll use a brain scan called a fMRI (functional magnetic resonance imaging) scan, which uses a strong magnetic field to take pictures of the brain
    * the side effects and blood levels of INDV-2000 when taken with methadone;
    * if INDV-2000 affects craving and anxiety.

    During the 4 weeks before the first study session, participants will have a screening visit. Participants will have 3 study sessions. Participants will take up to 3 weeks to finish the study and make up to 4 outpatient visits. Participants will take a single dose of INDV-2000 or placebo, by mouth. In each study session participants will come to the ward for an outpatient visit or stay on the ward for 1 night. Participants will have an fMRI scan in each study session.

    A pharmaceutical company (Indivior) is funding the study.

    The study will take place at 1 research centre and 1 imaging centre in London.

  • REC name

    Wales REC 1

  • REC reference

    24/WA/0044

  • Date of REC Opinion

    15 Apr 2024

  • REC opinion

    Further Information Favourable Opinion