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

NCT06384157 | Completed Phase 2 FDA Drug

• 1 other identifier: INDV-2000-201
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 35

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (11)

• Proportion (probability) of visits with opioid abstinence while participants are on IMP alone.

  From Week 1 to Week 13

• Participant's percentage of visits with opioid abstinence during the whole study follow-up.

  13 Weeks

• Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths.

  17 weeks

• Opioid Craving Assessment

  13 Weeks

• Cmax on Day 1 and Day 15/16

  2 Weeks

Study Arms (4)

100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets

EXPERIMENTAL

Drug: INDV-2000

200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets

EXPERIMENTAL

Drug: INDV-2000

400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets

EXPERIMENTAL

Drug: INDV-2000

Placebo dose

PLACEBO COMPARATOR

Other: Placebo

Interventions

INDV-2000 DRUG

INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD.

100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets; 200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets; 400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets

Placebo OTHER

This is a randomized, double-blind, placebo-controlled study.

Placebo dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• 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.
• 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.
• 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.
• Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below.
• 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.
• 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.
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
• Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
• Meet DSM-5 criteria for severe substance use disorder other than opioids.
• 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.
• Had an opioid overdose event within the 6 months prior to the Screening Visit.
• Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
• 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.
• Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
• Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
• 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.
• 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)

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (35)

Boyett Health Services Inc

Hamilton, Alabama, 35570, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

North County Clinical Research

Oceanside, California, 92054, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Artemis Institute For Clinical Research - San Diego

San Diego, California, 92103, United States

Location

Imagine Research of Palm Beach County

Boynton Beach, Florida, 33435, United States

Location

Bold City Clinical Research

Jacksonville, Florida, 32224, United States

Location

Vitalix Kissimmee

Kissimmee, Florida, 34741, United States

Location

Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States

Location

Quantum Clinical Trials

Miami Beach, Florida, 33140, United States

Location

Segal Trials Miami Lakes

Miami Lakes, Florida, 33016, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Agile Clinical Research Trials

Atlanta, Georgia, 30328, United States

Location

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

Location

Vitalix Clinical

Worcester, Massachusetts, 01608, United States

Location

Insight Research Institute

Flint, Michigan, 48507, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Arch Clinical Trials

St Louis, Missouri, 63141, United States

Location

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

Location

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Dr Vando Medical Services

The Bronx, New York, 10464, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

Pahl Pharmaceutical Professionals, LLC

Oklahoma City, Oklahoma, 73112, United States

Location

SP Research PLLC Rivus Wellness and Research Insitute

Oklahoma City, Oklahoma, 73112, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Prisma Health Addiction Medicine Center

Greenville, South Carolina, 29605, United States

Location

Insite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

El Paso Clinical Trials

El Paso, Texas, 79902, United States

Location

HD Research

Houston, Texas, 77043, United States

Location

Progressive Clinical Research Llc

Bountiful, Utah, 84010, United States

Location

Alpine Research Organisation

Clinton, Utah, 84015, United States

Location

Boeson Clinical Research

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Global Director Clinical Development

  Indivior Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a randomized, double-blind, placebo-controlled study where the investigator, assessor, sponsor and participant are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: June 10, 2024
• Primary Completion: September 29, 2025
• Study Completion: November 3, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-10

Locations

US (35)