CompletedPhase IInterventional

An fMRI study to assess the effects of INDV-2000 on brain activity in opioid-dependent participants taking methadone

This phase 1 clinical trial is looking at an experimental medicine called INDV-2000. It is being tested to see if it can help treat opioid addiction by reducing cravings and withdrawal symptoms. The study involves 36 adults who are currently taking a stable daily dose of methadone. Researchers want to see how INDV-2000 affects brain activity when people are shown heroin-related pictures or items. To do this, participants will have functional MRI (fMRI) brain scans. Taking part lasts around three weeks and involves up to four outpatient visits or short hospital stays in London. Participants will take a single dose of the study medicine or a dummy pill (placebo) on test days. The trial will also look at safety and any side effects when INDV-2000 is taken alongside methadone. There is no direct medical benefit expected for participants.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Indivior Inc.

Enrolment target

Start

29 Aug 2024

Estimated completion

15 Dec 2025

Opioid use disorder

What is this study about?

Opioid addiction, also known as opioid use disorder, is a long-term condition that can cause intense cravings and physical withdrawal symptoms. While treatments like methadone help many people, cravings can still lead to relapse. Researchers are looking for new medicines that can act on specific brain chemical systems to help reduce these urges.

INDV-2000 is an experimental tablet designed to block certain brain proteins called orexin-1 receptors. These receptors are thought to play an important role in cravings, stress, and relapse. By dampening this brain response, scientists hope the medicine might make it easier for people to stay in recovery in the future.

In this early-stage study, researchers are using functional MRI (fMRI) brain scans to see how INDV-2000 works in real time. The scans use magnets and radio waves to take safe pictures of blood flow in the brain. By showing participants images linked to opioids during the scan, doctors can see whether the medicine calms down the brain regions that react to drug triggers. This trial helps scientists decide if INDV-2000 should be developed further as a real-world treatment.

Key takeaways

Tests whether a new medicine (INDV-2000) reduces brain reactions to opioid triggers.
Designed for adults aged 18 to 65 taking a stable daily dose of methadone (up to 120 mg).
Involves fMRI brain scans and up to 4 outpatient visits or overnight stays in London over roughly 3 weeks.
Led by experienced NHS addiction specialists to ensure patient safety and comfort.
There is no direct medical benefit, and participation is entirely voluntary.

Who may be eligible?

This study is open to men and women aged 18 to 65 who have opioid dependence and are currently taking a stable dose of methadone (up to 120 mg per day) that they take at home. To take part, your methadone dose must have been steady for at least one month, with no dose increases in the 10 days before your screening check.

You cannot join if you take more than 120 mg of methadone daily, or if you have serious heart, kidney, liver, breathing, or nervous system conditions. People with sleep disorders like narcolepsy or sleep apnoea are also not eligible, as the medicine affects brain systems linked to sleep and alertness.

Participants must have a healthy body weight (BMI between 18 and 35) and weigh at least 50 kg. Because the effects on an unborn child are not known, you cannot take part if you are pregnant or breastfeeding, and you must agree to use reliable contraception during the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 18 and 65 years old.
I have been taking a stable daily dose of take-home methadone (120 mg or less) for at least one month.
My methadone dose has not increased in the past 10 days.
I do not have sleep apnoea, narcolepsy, or serious liver, kidney, or heart conditions.
I am not pregnant or breastfeeding, and I am willing to use reliable contraception.
I am able to travel to the research centre in London and lie still for an MRI scan.

Answer every question to see your result.

What does participation involve?

Taking part lasts about three weeks, after an initial screening visit that takes place within four weeks of starting. In total, you will make up to four clinic visits to the research centre in London. During your visits, you will have three main study sessions, which involve either staying on the hospital ward for the day or staying overnight for one night.

At each session, you will take a single dose of either INDV-2000 or a placebo (a dummy pill containing no active drug), alongside your regular prescribed methadone. You will bring your own daily methadone with you to the clinic, where you might take it slightly later than your usual time.

You will have an fMRI brain scan during each session. During the scan, you will lie still inside a scanner tunnel while viewing images on a screen, some of which may be linked to heroin. Staff will also take regular blood samples, check your heart and blood pressure, and ask questions about your mood, anxiety, and cravings. Once the sessions are complete, you will have a final health follow-up.

Potential risks and benefits

You should not expect any direct health benefits from taking part, as this is an early-stage study testing how the drug works. However, your involvement could help scientists develop better treatments for addiction in the future. The medicine has already been tested in over 130 people; reported side effects were generally mild and included sleepiness, headache, dizziness, tiredness, dry mouth, and back pain. The brain scan task may briefly trigger cravings or anxiety, but experienced NHS addiction doctors and nurses will support you throughout. You can leave the study at any time without giving a reason, and doing so will not affect your normal NHS care or methadone prescription.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Research Facility (ICRF) within Imperial College Healthcare NHS Trust
Unverified
London, England
Invicro
Unverified
London, England

Common questions

Will taking part affect my normal methadone prescription?

No. You will continue taking your normal prescribed methadone throughout the study. On study days, you will bring your dose to the clinic, so you may take it a few hours later than usual under medical supervision.

What is an fMRI scan and does it hurt?

An fMRI is a harmless, painless scan that uses magnets to look at brain activity. It does not use radiation, but the scanner can be quite loud, so you will wear ear protection while lying flat inside the machine.

Will INDV-2000 cure my addiction?

No. You will only receive single test doses during the study, so it will not treat or cure your condition. The goal is simply to see how the brain responds to the medicine.

What happens if looking at drug-related pictures makes me crave heroin?

The research team is led by specialist addiction doctors who are trained to help with uncomfortable feelings. They will be on hand to support you and make sure you feel settled before you leave.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw at any point, and your standard addiction care and relationship with your doctors will stay exactly the same.

How to find out more

Usha Sukumaran

TrialDisclosure@Indivior.com +1 (804) 615-9945 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.