INDV-2000 for Opioid Use Disorder

No longer recruiting at 3 trial locations

Overseen By Robert Dobbins

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Indivior Inc.

Must be taking: Suboxone

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Cardiac illness, Hepatic disease, HIV, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called INDV-2000. In its early phase, healthy volunteers receive different doses of INDV-2000 to assess how their bodies handle it. Later, the trial evaluates the safety of INDV-2000 when combined with SUBOXONE, a treatment for opioid use disorder (OUD), in individuals seeking help for their OUD. Those diagnosed with moderate or severe OUD and seeking treatment might be a good fit for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, for healthy volunteers in Parts I and II, you should not have taken any prescribed or over-the-counter drugs (except certain exceptions) in the 14 days before the trial. For Part III, those seeking treatment for opioid use disorder should not have received medication-assisted treatment like methadone or buprenorphine in the 30 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INDV-2000 was safe in early studies. In a previous study, researchers tested this new treatment on healthy volunteers for up to 28 days, and no major safety issues emerged. The study was carefully controlled, with some participants receiving a placebo (a substance with no active ingredients) for comparison.

For individuals with opioid use disorder (OUD), INDV-2000 is being tested both alone and with SUBOXONE. Over 3,000 people with opioid dependence have used SUBOXONE, so its safety is well-known. However, like any medication, it can cause side effects, including serious ones like slowed breathing.

While early study results are promising, it's important to remember that this trial is in an early phase. This phase focuses on assessing safety and how well people tolerate the treatment. Researchers continue to gather information to ensure INDV-2000 is safe with repeated use. If considering participation, discuss the possible risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

INDV-2000 is unique because it offers a new approach to treating opioid use disorder by potentially enhancing the effects of existing medications like SUBOXONE. Unlike standard treatments that primarily focus on managing withdrawal and preventing relapse, INDV-2000 could work in synergy with SUBOXONE to improve overall treatment outcomes. Researchers are excited because this combination has the potential to offer a more comprehensive solution, possibly reducing opioid cravings more effectively and helping patients maintain long-term recovery.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research shows that INDV-2000 is a new treatment under study for opioid use disorder. This non-opioid medication targets specific brain receptors linked to addiction behaviors. Early results suggest that blocking these receptors can help reduce cravings and withdrawal symptoms. The trial tests INDV-2000 in various treatment arms, including one combined with SUBOXONE, a well-known treatment for opioid use disorder. SUBOXONE has helped many people reduce opioid use and manage withdrawal symptoms. Together, these treatments might offer a promising option for those seeking help with opioid addiction. ^{6 7 8 9 10}

Who Is on the Research Team?

Martin Kankam

Principal Investigator

altasciences

Ellen Remenchik

Principal Investigator

Worldwide Clinical Trails

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

Female subjects of child-bearing potential who are sexually active with males must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 30 days after the last dose of Investigational Medicinal Product (IMP). The impact of IMP on the efficacy of hormonal contraceptives is unknown. Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of IMP and agree to not donate sperm over this time period. Effective methods of contraception are: Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; Progestogen-only hormonal contraception: oral, injectable/implantable, or intrauterine hormone-releasing system (IUD); Implantable intrauterine device (IUS); Surgical sterilization (for example, vasectomy or bilateral tubal ligation); Male condom with spermicidal gel/foam or with female cap or diaphragm (double barrier); abstinence from heterosexual intercourse as a conscious choice and established pattern of lifestyle.

Body mass index (BMI) within 18.0 to 32.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).

Exclusion Criteria

Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.

Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator or medically responsible physician.

Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part I

Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers

1 week

Daily visits for dosing

Treatment Part II

Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers

4 weeks

Daily visits for dosing

Treatment Part III

Open-label study in OUD treatment seeking individuals with a run-in period of SUBOXONE SL film for 6 days, followed by combination treatment with INDV-2000 and SUBOXONE for 7 days, and INDV-2000 alone for 4 days

17 days

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INDV-2000
• Placebo
• SUBOXONE® sublingual film

How Is the Trial Designed?

Group I: Part III INDV-2000 400 mg BID + SUBOXONE SL Film Experimental Treatment 2 Interventions

Participants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days.

Group II: Part II Cohort 2 INDV-2000 400 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days.

Group III: Part II Cohort 1 INDV-2000 200 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days.

Group IV: Part I Cohort 2 INDV-2000 100 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days.

Group V: Part I Cohort 1 INDV-2000 100 mg QD Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days.

Group VI: Part I Cohort 1 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo once daily for 7 days.

Group VII: Part I Cohort 2 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 7 days.

Group VIII: Part II Cohort 1 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 28 days.

Group IX: Part II Cohort 2 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 28 days.

Who Is Running the Clinical Trial?

Indivior Inc.

Lead Sponsor

Trials

56

Recruited

11,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244226/

A novel, non-opioid, selective orexin-1 receptor antagonist for ... There is a pressing need for novel treatments for substance use disorders to address increasing rates of addiction and drug overdose.

2. indivior.com indivior.com/en/media/press-releases/Indivior-Announces-Dosing-of-First-Subject-with-INDV-2000-in-a-Phase-2-Study-Assessing-the-Safety-and-Efficacy-of-INDV-2000-in-Individuals-with-Opioid-Use-Disorder

Indivior Announces Dosing of First Subject with INDV-2000 ... Double-blind, placebo-controlled study aims to measure safety and efficacy of INDV-2000 over 3 months in participants with moderate to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552597/

Found in translation: orexin receptor antagonism for the ... Nevertheless, this clinical trial provides clear evidence that dual orexin receptor antagonism treatment exerts beneficial effects for ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06384157/proof-of-concept-and-dose-ranging-study-of-indv-2000-in-individuals-with-moderate-to-severe-opioid-use-disorder

Proof of Concept and Dose-ranging Study of INDV-2000 in ... The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05694533/Prot_000.pdf

CLINICAL STUDY PROTOCOL: INDV-2000-104 The most relevant data on INDV-2000 for the present study are summarised below. A detailed description of the chemistry, pharmacology ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/55/NCT04976855/Prot_000.pdf

CLINICAL STUDY PROTOCOL: INDV-2000-102 This study is a Phase I, double-blind, placebo-controlled trial of INDV-2000 in healthy volunteers up to 28 days, and open-label in opioid use ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772408524001182

A novel, non-opioid, selective orexin-1 receptor antagonist ... C4X3256 has an acceptable profile in preliminary safety studies. In vitro automated patch clamp electrophysiology studies showed that C4X3256 has an IC50 ...

8. ctv.veeva.com ctv.veeva.com/study/proof-of-concept-and-dose-ranging-study-of-indv-2000-in-individuals-with-moderate-to-severe-opioid-u

Proof of Concept and Dose-ranging Study of INDV-2000 in ... This study measures safety and efficacy of INDV-2000 for moderate to severe OUD, determining dose-response in those transitioning to non-opioid ...

9. prnewswire.com prnewswire.com/news-releases/indivior-announces-dosing-of-first-subject-with-indv-2000-in-a-phase-2-study-assessing-the-safety-and-efficacy-of-indv-2000-in-individuals-with-opioid-use-disorder-302168484.html

Indivior Announces Dosing of First Subject with INDV-2000 ... Double-blind, placebo-controlled study aims to measure safety and efficacy of INDV-2000 over 3 months in participants with moderate to ...

10. isrctn.com isrctn.com/ISRCTN15079632

An fMRI study to assess the effects of INDV-2000 on brain ... To explore safety and tolerability of INDV-2000 when administered in combination with methadone 3. To explore the effect of INDV-2000 on patient-reported ...