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Opioid Use DisorderPhase 2NCT06384157

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

A Phase 2 study testing INDV-2000 in people with Opioid Use Disorder, run by Indivior Inc. at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
INDV-2000
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
35 sitesUnited States
Study dates
10 Jun 2024to 3 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • She is not lactating.
  • Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive)

Who cannot join

  • 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.
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  • 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)
  • 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.
  • 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.
  • Current symptomatic hepatic or biliary disease, including participants with cholecystectomy <90 days prior to Screening.
  • Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
  • 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.
  • 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).
  • Known allergy or hypersensitivity to IMP or its excipients.
  • 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.
  • 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).
  • 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.
  • Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Agile Clinical Research Trials

    Atlanta, Georgia, 30328

  • Maryland Treatment Centers

    Baltimore, Maryland, 21229

  • Progressive Clinical Research Llc

    Bountiful, Utah, 84010

  • Imagine Research of Palm Beach County

    Boynton Beach, Florida, 33435

  • Alpine Research Organisation

    Clinton, Utah, 84015

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio, 45417

  • Insite Clinical Research, LLC

    DeSoto, Texas, 75115

  • El Paso Clinical Trials

    El Paso, Texas, 79902

  • Insight Research Institute

    Flint, Michigan, 48507

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Prisma Health Addiction Medicine Center

    Greenville, South Carolina, 29605

  • Boyett Health Services Inc

    Hamilton, Alabama, 35570

  • HD Research

    Houston, Texas, 77043

  • Bold City Clinical Research

    Jacksonville, Florida, 32224

  • Vitalix Kissimmee

    Kissimmee, Florida, 34741

  • Accel Research Sites - Lakeland

    Lakeland, Florida, 33803

  • IMA Clinical Research

    Las Vegas, Nevada, 89102

  • Oasis Clinical Research

    Las Vegas, Nevada, 89121

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

  • Segal Trials Miami Lakes

    Miami Lakes, Florida, 33016

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • West Clinical Research

    Morehead City, North Carolina, 28557

  • North County Clinical Research

    Oceanside, California, 92054

  • Pahl Pharmaceutical Professionals, LLC

    Oklahoma City, Oklahoma, 73112

  • SP Research PLLC Rivus Wellness and Research Insitute

    Oklahoma City, Oklahoma, 73112

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Empire Clinical Research

    Pomona, California, 91767

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Boeson Clinical Research

    Provo, Utah, 84604

  • Artemis Institute For Clinical Research - San Diego

    San Diego, California, 92103

  • Arch Clinical Trials

    St Louis, Missouri, 63141

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

  • Dr Vando Medical Services

    The Bronx, New York, 10464

  • Vitalix Clinical

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
INDV-2000, Placebo
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INDV-2000Drug

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

  • PlaceboOther

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

Study groups in NCT06384157
Study groupRoleWhat they receive
100 mg INDV-2000 QD dosed by two 50 mg extended-release tabletsExperimentalNot described
Receives: Drug: INDV-2000
200 mg INDV-2000 QD dosed by two 100 mg extended-release tabletsExperimentalNot described
Receives: Drug: INDV-2000
400 mg INDV-2000 QD dosed by two 200 mg extended-release tabletsExperimentalNot described
Receives: Drug: INDV-2000
Placebo dosePlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (11)

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

    Abstinence is based on negative UDS and self-report use.

    Measured: From Week 1 to Week 13

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

    Abstinence is based on negative UDS and self-report use.

    Measured: 13 Weeks

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

    Number of participants reporting adverse events

    Measured: 17 weeks

  4. Opioid Craving Assessment

    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.

    Measured: 13 Weeks

  5. Cmax on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  6. Tmax on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  7. AUC0-24 on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  8. Cavg on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  9. Cmin on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  10. CL/F on Day 1 and Day 15/16

    PK sampling are done under the PK Substudy

    Measured: 2 Weeks

  11. Clinical Opiate Withdrawal Scale (COWS) score

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start10 Jun 2024
  3. Primary completion29 Sep 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06384157
Sponsor's protocol ID
INDV-2000-201
Status last verified
Oct 2025
First submitted
22 Apr 2024
Last updated
16 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INDV-2000 in people with Opioid Use Disorder, run by Indivior Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06384157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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