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INDV-2000 for Opioid Use Disorder

Phase 2

Recruiting

Research Sponsored by Indivior Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 18 to 65 years of age inclusive at the time of signing the informed consent

Female participants must use contraception if of childbearing potential, not pregnant, and not lactating

Must not have

Current diagnosis requiring chronic opioid treatment other than OUD

Recent blood/plasma donation, anemia, allergy to IMP or excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 1 to week 13

Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a new drug called INDV-2000 in people with moderate to severe Opioid Use Disorder who have recently stopped using opioids and want to switch

Who is the study for?

This trial is for adults aged 18-65 with moderate to severe Opioid Use Disorder, who are transitioning from short-term opioid treatment to non-opioid alternatives. Participants must not have used opioid medication for the past 3 months and should be within 10 days of their last buprenorphine dose. Women must use contraception and cannot be pregnant or lactating.

What is being tested?

The study tests INDV-2000's safety and effectiveness in helping individuals with Opioid Use Disorder after they've stopped using opioids like buprenorphine. It compares different doses of INDV-2000 against a placebo to find the best dose.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions to INDV-2000 compared to those taking a placebo. Side effects could range from mild discomforts like headaches or nausea to more serious conditions depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am not pregnant, breastfeeding, and will use birth control if I can have children.

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My BMI is between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on long-term opioid medication for a condition other than opioid use disorder.

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I haven't donated blood recently, don't have anemia, and am not allergic to any medication ingredients.

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I do not have major health issues with my brain, heart, kidneys, liver, lungs, stomach, or mental health.

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I have a history of sleep disorders or conditions affecting how drugs work in my body.

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I do not have serious heart conditions like uncontrolled heart rhythm problems, recent heart attack, or severe chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 1 to week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 1 to week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 1 to week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85).

Secondary outcome measures

AUC0-24 on Day 1 and Day 15/16

CL/F on Day 1 and Day 15/16

Cavg on Day 1 and Day 15/16

+8 more

Side effects data

From 2021 Phase 1 trial • 73 Patients • NCT04413552

17%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Part I: INDV-2000 360 mg

Part I: INDV-2000 5 mg

Part I: INDV-2000 20 mg

Part I: INDV-2000 120 mg

Part I: INDV-2000 50 mg

Part I: INDV-2000 180 mg

Part I: Pooled Placebo

Part II Period 1: INDV-2000 360 mg Fasted

Part I: INDV-2000 720 mg

Part II Period 2: INDV-2000 360 mg Fed

Part I: INDV-2000 1 mg

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 400 mg INDV-2000 QD dosed by two 200 mg extended-release tabletsExperimental Treatment1 Intervention

Group II: 200 mg INDV-2000 QD dosed by two 100 mg extended-release tabletsExperimental Treatment1 Intervention

Group III: 100 mg INDV-2000 QD dosed by two 50 mg extended-release tabletsExperimental Treatment1 Intervention

Group IV: Placebo dosePlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INDV-2000

2020

Completed Phase 1

~160

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indivior Inc.Lead Sponsor

55 Previous Clinical Trials

11,081 Total Patients Enrolled

Global Director Clinical DevelopmentStudy DirectorIndivior Inc.

5 Previous Clinical Trials

1,863 Total Patients Enrolled

~200 spots leftby Aug 2025

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