Completed

INDV-2000 for Opioid Use Disorder

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Study Aim

This study aims to evaluate if INDV-2000 can effectively help adults with opioid use disorder avoid treatment failure over 12 weeks.

What is being tested

INDV-2000

+ Placebo

DrugOther
Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Opioid-Related Disorders

From 18 to 65 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorIndivior Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2024

Actual date on which the first participant was enrolled.

This study is aimed at helping people who are seeking treatment for opioid use disorder. It is important because opioid use disorder is a challenging condition that affects many individuals, and finding effective treatments can significantly improve their quality of life. The study is testing a new drug called INDV-2000 to see if it is safe and effective over a period of three months. By exploring different doses, the study hopes to find the most beneficial and safe dosage for treating this condition. Participants in the study will initially receive a treatment called TM buprenorphine along with either INDV-2000 or a placebo for the first week. After the first week, they will continue with only INDV-2000 or placebo for the remainder of the study. The study will track the participants from the start of their randomized treatment to their last visit, unless they begin a "rescue therapy" with buprenorphine if needed. This approach helps researchers evaluate the effects of INDV-2000 on managing opioid use disorder without the influence of other medications.

Official TitleA Phase II Double Blind, Placebo Controlled, Randomised, Dose-Ranging Study to Assess the Safety and Efficacy of INDV-2000 Over 3 Months in Treatment Seeking Individuals With Opioid Use Disorder
NCT06384157
Principal SponsorIndivior Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

7 inclusion criteria required to participate
Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
A female participant of non-childbearing potential, or a male of childbearing potential if * She agrees to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: abstinence; established use or oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide). * She is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1. * She is not lactating.
Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below. 1. The participant will initiate, or is undergoing medically supervised withdrawal, and * In the opinion of the investigator, the participant is able to achieve a stable dose of transmucosal (TM) buprenorphine between ≤24 mg inclusive prior to randomization. * Current opioid agonist treatment does not exceed 35 days from the start of TM buprenorphine to the end of Screening window. 2. The participant recently completed medically supervised withdrawal outside of the study, and * Time elapsed between last dose of TM buprenorphine or other withdrawal medication and Study Day 1/randomization does not exceed 21 calendar days. * Recently completed opioid agonist treatment does not exceed 35 days of TM buprenorphine dosing days inclusive of medically assisted withdrawal dosing.
Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable forms of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: established use of oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide), or abstinence.
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21 exclusion criteria prevent from participating
Known allergy or hypersensitivity to IMP or its excipients.
Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements, including prohibited concomitant therapies.
Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff, Indivior, or Clinical Research Organization \[CRO\] employee).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 35 locations

Suspended

Boyett Health Services Inc

Hamilton, United StatesOpen Boyett Health Services Inc in Google Maps
Suspended

Elite Clinical Studies, LLC

Phoenix, United States
Suspended

North County Clinical Research

Oceanside, United States
Suspended

Empire Clinical Research

Pomona, United States
Completed35 Study Centers