Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder

December 15, 2025 updated by: Indivior Inc.

A 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

The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

From Day 1 to Day 7, TM buprenorphine and randomized INDV-2000/Placebo will be administered, INDV-2000/Placebo will be administered alone from Day 8 onward. The randomized treatment period starts when the participant receives randomized treatment (at Day 1) and ends at his/her last study visit, if on INDV-2000/Placebo alone, or ends when starting buprenorphine rescue therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Hamilton, Alabama, United States, 35570
        • Boyett Health Services Inc
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
    • California
      • Oceanside, California, United States, 92054
        • North County Clinical Research
      • Pomona, California, United States, 91767
        • Empire Clinical Research
      • San Diego, California, United States, 92103
        • Artemis Institute For Clinical Research - San Diego
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Imagine Research of Palm Beach County
      • Jacksonville, Florida, United States, 32224
        • Bold City Clinical Research
      • Kissimmee, Florida, United States, 34741
        • Vitalix Kissimmee
      • Lakeland, Florida, United States, 33803
        • Accel Research Sites - Lakeland
      • Miami Beach, Florida, United States, 33140
        • Quantum Clinical Trials
      • Miami Lakes, Florida, United States, 33016
        • Segal Trials Miami Lakes
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center Of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Agile Clinical Research Trials
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Maryland Treatment Centers
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Vitalix Clinical
    • Michigan
      • Flint, Michigan, United States, 48507
        • Insight Research Institute
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Arch Clinical Trials
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Ima Clinical Research
      • Las Vegas, Nevada, United States, 89121
        • Oasis Clinical Research
    • New York
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates
      • The Bronx, New York, United States, 10464
        • Dr Vando Medical Services
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Morehead City, North Carolina, United States, 28557
        • West Clinical Research
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pahl Pharmaceutical Professionals, LLC
      • Oklahoma City, Oklahoma, United States, 73118
        • Unity Clinical Research
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research PLLC Rivus Wellness and Research Insitute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Addiction Medicine Center
    • Texas
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research, LLC
      • El Paso, Texas, United States, 79902
        • El Paso Clinical Trials
      • Houston, Texas, United States, 77043
        • HD Research
    • Utah
      • Bountiful, Utah, United States, 84010
        • Progressive Clinical Research Llc
      • Clinton, Utah, United States, 84015
        • Alpine Research Organisation
      • Provo, Utah, United States, 84604
        • Boeson Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants are eligible to be included in the study only if all of the following criteria apply:

    1. Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed consent.
    2. 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.
    3. Males or females with moderate or severe opioid use disorder (OUD) by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who are looking to transition from daily short-term opioid agonist treatment (medically supervised withdrawal) to non-opioid treatment.

    4. 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.
    5. 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.

    6. 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.
    7. Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive)

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:

    1. Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
    2. Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
    3. Meet DSM-5 criteria for severe substance use disorder other than opioids.
    4. Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder that would impact participation in the study as judged by an Investigator or medically responsible physician.
    5. Had an opioid overdose event within the 6 months prior to the Screening Visit.
    6. Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
    7. Have clinically significant abnormal biochemistry, hematology or urinalysis results that would impact participation in the study as judged by an Investigator or medically responsible physician.
    8. Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
    9. Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
    10. History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.

    11. Serious cardiac illness or other cardiac assessments including, but not limited to:

      • Uncontrolled arrhythmias.
      • History of congestive heart failure.
      • Myocardial infarction <6 months from receipt of first dose of investigational medicinal product (IMP)
      • Uncontrolled symptomatic angina
      • QT interval corrected with Fridericia's formula (QTcF) >450 msec for males and >470 msec for females or history of prolonged QT syndrome.

    12. Have any combination of the following at screening:

      • Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin >1.3 mg/dL),
      • Alanine aminotransferase (ALT) ≥3×ULN
      • Aspartate aminotransferase (AST) ≥3×ULN
      • International normalized ratio (INR) >1.2 for participants not receiving anticoagulation therapy, >3.0 for participants on conventional coagulation therapy, >3.5 for participants on intensive anticoagulation, or
      • Estimated glomerular filtration rate <60 mL/min by Cockroft-Gault formula.
    13. Current symptomatic hepatic or biliary disease, including participants with cholecystectomy <90 days prior to Screening.
    14. Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
    15. Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to the signing the informed consent form.
    16. Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (<11 g/dL for females, <12 g/dL for males).
    17. Known allergy or hypersensitivity to IMP or its excipients.
    18. Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results.
    19. 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).
    20. 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.
    21. Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo dose
Other: Placebo
This is a randomized, double-blind, placebo-controlled study.
Experimental: 100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets
Drug: INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
Experimental: 200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets
Drug: INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.
Experimental: 400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets
Drug: INDV-2000
INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85).
Time Frame: 12 weeks

The treatment failure is defined as meeting either one of the two criteria.

  1. Urine Drug Screen (UDS, dipstick) positive for opioids, or fentanyl on 4 consecutive assessments while participants on the Investigational Medicinal Product (IMP) (INDV-2000 or placebo) alone (after Day 8 visit).
  2. Discontinued the IMP (INDV-2000 or placebo) prematurely.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion (probability) of visits with opioid abstinence while participants are on IMP alone.
Time Frame: From Week 1 to Week 13
Abstinence is based on negative UDS and self-report use.
From Week 1 to Week 13
Participant's percentage of visits with opioid abstinence during the whole study follow-up.
Time Frame: 13 Weeks
Abstinence is based on negative UDS and self-report use.
13 Weeks
Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths.
Time Frame: 17 weeks
Number of participants reporting adverse events
17 weeks
Opioid Craving Assessment
Time Frame: 13 Weeks
7-item self-reported instrument to assess the participant's craving in the past week, on a likert scale of 1 to 7 (Strongly Disagree as 1, Disagree, Slightly Disagree, Neither Agree nor Disagree, Slightly Agree, Agree, or Strongly Agree as 7). The 7 questions assess general craving, and the following 6 dimensions: preoccupation or obsessive thoughts, anticipation of negative reinforcement, anticipation of positive reinforcement, motivation, drive and intention to use opioids, feeling lack of control or automaticity, and feeling uneasiness related to opioid use.
13 Weeks
Cmax on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
Tmax on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
AUC0-24 on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
Cavg on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
Cmin on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
CL/F on Day 1 and Day 15/16
Time Frame: 2 Weeks
PK sampling are done under the PK Substudy
2 Weeks
Clinical Opiate Withdrawal Scale (COWS) score
Time Frame: 4 weeks
The COWS is an 11-item, validated instrument used to assess symptoms of opiate withdrawal. The score is the sum of the response to each of the 11 items and ranges from 0 to 48. A score of 5 to 12 is considered mild, 13 to 24 is moderate, 25 to 36 is moderately severe, and a score >36 is considered severe withdrawal.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indivior Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Director Clinical Development, Indivior Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INDV-2000-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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