INDV-2000 for Opioid Use Disorder

No longer recruiting at 36 trial locations

Overseen By Eric M Chavez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Indivior Inc.

Must be taking: Transmucosal buprenorphine

Must not be taking: Long-acting buprenorphine, Naltrexone

Disqualifiers: Chronic opioid treatment, Severe substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of INDV-2000, a new potential drug for individuals with moderate to severe opioid use disorder (OUD) who have recently stopped or are stopping opioid treatment and wish to switch to a non-opioid option. The study will test various doses to identify the most effective one, comparing them to a placebo (a pill with no active drug). Suitable candidates have moderate to severe OUD, have recently completed or are undergoing withdrawal with buprenorphine, and are interested in non-opioid treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in OUD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not been on medication for opioid use for 3 months prior to the current treatment episode. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that INDV-2000 is likely to be safe for humans?

Research shows that INDV-2000, a pill that blocks a specific brain receptor, has undergone safety testing in people with opioid use disorder. Other studies have also assessed its safety and tolerability. For instance, one study reviewed participant data to ensure it was safe to continue testing. Another study included a phone call 90 days after the last dose to check for any new issues like pain or swelling.

Although the treatment remains in the early stages of human testing, animal studies have shown promising results, suggesting it might be safe. However, as this is a phase 2 trial, researchers are still gathering evidence about its safety in humans. Participants will receive close monitoring during the trial to manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Opioid Use Disorder?

Unlike the standard treatments for opioid use disorder, which often involve medications like methadone, buprenorphine, and naltrexone, INDV-2000 is generating excitement due to its innovative extended-release tablet form. This unique delivery method allows for once-daily dosing, which could improve adherence and convenience for patients. Additionally, the varied dosages of 100 mg, 200 mg, and 400 mg allow for tailored treatment options to better meet individual patient needs. Researchers are particularly interested in how INDV-2000 might offer a new mechanism of action or improved efficacy compared to existing therapies, potentially leading to better outcomes for those struggling with opioid dependence.

What evidence suggests that INDV-2000 might be an effective treatment for Opioid Use Disorder?

Research has shown that INDV-2000 could be a promising treatment for opioid use disorder (OUD). Studies have found that it blocks certain brain signals related to addiction. In animal studies, this has helped reduce behaviors linked to addiction. The treatment does not rely on opioids, which is important for those who want to avoid opioid medications. Early safety data suggests it is generally well-tolerated. In this trial, participants will receive different dosages of INDV-2000 or a placebo. Although research in humans is still ongoing, these findings offer hope for INDV-2000's potential effectiveness in treating OUD. ^{2 5 6 7 8}

Who Is on the Research Team?

Global Director Clinical Development

Principal Investigator

Indivior Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with moderate to severe Opioid Use Disorder, who are transitioning from short-term opioid treatment to non-opioid alternatives. Participants must not have used opioid medication for the past 3 months and should be within 10 days of their last buprenorphine dose. Women must use contraception and cannot be pregnant or lactating.

Inclusion Criteria

Able to verbalize understanding of the consent form, provide written informed consent, and comply with protocol requirements

Not on medication for opioid use for 3 months prior to current treatment episode

I agree to use contraception as a sexually active male.

Exclusion Criteria

Injection substance abuse more than 1 time per week

I am on long-term opioid medication for a condition other than opioid use disorder.

I do not have serious heart conditions like uncontrolled heart rhythm problems, recent heart attack, or severe chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TM buprenorphine and randomized INDV-2000/Placebo from Day 1 to Day 7, followed by INDV-2000/Placebo alone from Day 8 onward

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for adverse events and opioid abstinence

17 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INDV-2000

Trial Overview

The study tests INDV-2000's safety and effectiveness in helping individuals with Opioid Use Disorder after they've stopped using opioids like buprenorphine. It compares different doses of INDV-2000 against a placebo to find the best dose.

How Is the Trial Designed?

Group I: 400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets Experimental Treatment 1 Intervention

Group II: 200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets Experimental Treatment 1 Intervention

Group III: 100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets Experimental Treatment 1 Intervention

Group IV: Placebo dose Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Indivior Inc.

Lead Sponsor

Trials

56

Recruited

11,400+

Published Research Related to This Trial

The review of 18 studies indicates that treating ADHD in patients with opioid use disorder (OUD) can lead to better retention in OUD treatment programs and improvements in ADHD severity.

While the specific medications for OUD treatment could not be prioritized, the findings suggest that addressing ADHD symptoms is important for reducing illicit substance abuse in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaps in Evidence-based Treatment of Concurrent Attention Deficit Hyperactivity Disorder and Opioid Use Disorder: A Scoping Review. Ramey, OL., Bonny, AE., Silva Almodóvar, A., et al.[2023]

In a 48-week study involving 200 participants with opioid addiction and HIV, the naltrexone implant group showed a significant improvement in maintaining viral loads below 400 copies per mL at 48 weeks compared to the oral naltrexone group, suggesting that long-acting naltrexone may enhance HIV treatment outcomes.

Despite some serious adverse events, including deaths in both groups, the study indicates that longer opioid blockade from the implant may help protect against missed antiretroviral therapy doses and impulsive behaviors that could lead to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-release naltrexone implant versus oral naltrexone for improving treatment outcomes in people with HIV who are addicted to opioids: a double-blind, placebo-controlled, randomised trial. Krupitsky, E., Blokhina, E., Zvartau, E., et al.[2020]

Leu-enkephalin (LENK) significantly reduced locomotor activity in male Wistar rats when injected into the brain, indicating its role in modulating movement through central delta-opioid receptors.

The antagonist ICI 174864 blocked the effects of LENK and induced abnormal behavior at higher doses, suggesting it can be used as a model to study delta-opioid receptor functions, while also enhancing the analgesic effects of morphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central effects of a selective delta-opioid receptor antagonist, ICI 174864. Herman, ZS., Stańda, J., Janas, P., et al.[2013]

Naltrexone, particularly in its long-acting implant form, has shown promise in treating opioid use disorder (OUD) by reducing heroin use and improving treatment compliance compared to oral administration, as evidenced by studies indicating fewer days of heroin use and more negative drug tests among compliant patients.

Importantly, naltrexone does not appear to worsen mental health symptoms associated with OUD, and it has been linked to a significant reduction in mental health-related hospitalizations, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone Implant for Opioid Use Disorder. Edinoff, AN., Nix, CA., Orellana, CV., et al.[2022]

A Stanford University analysis predicts 510,000 deaths from prescription opioids and heroin in the US from 2016 to 2025, highlighting the urgent need for effective treatment strategies.

An open-label study suggests that combining naltrexone with a dopamine-regulating agent (KB220) significantly improves treatment compliance and outcomes, with patients remaining on treatment for an average of 262 days compared to just 37 days with naltrexone alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving naltrexone compliance and outcomes with putative pro- dopamine regulator KB220, compared to treatment as usual. Blum, K., Lott, L., Baron, D., et al.[2022]

Citations

1.

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 ...

2.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/indivior-opioid-use-disorder-trial/

Indivior doses first participant in Phase II opioid use ...

INDV-2000, an oral orexin-1 receptor (OX1R) antagonist, has shown promising results in rodent models of addiction and has a safety profile that ...

3.

pmc.ncbi.nlm.nih.gov

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

A novel, non-opioid, selective orexin-1 receptor antagonist for ...

The published nonclinical data for selective OX1R antagonists suggest that OX1R antagonists should reduce addiction-related behaviours for a ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/indivior-begins-phase-2-study-of-indv-2000-for-opioid-use-disorder

Indivior Begins Phase 2 Study of INDV-2000 for Opioid Use ...

This double-blind, placebo-controlled study aims to assess the safety and efficacy of INDV-2000 over a period of three months. INDV-2000 works ...

5.

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 ...

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 ...

6.

cdn.clinicaltrials.gov

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

CLINICAL STUDY PROTOCOL: INDV-2000-102

Male participants will complete a safety phone call 90 days after their last dosing day to assess any new pain, swelling or nodular lesions in ...

7.

isrctn.com

isrctn.com/ISRCTN15079632

An fMRI study to assess the effects of INDV-2000 on brain ...

To explore the effects of INDV-2000 on the brain's response to drug related cues in participants with opioid use disorder. 2. To explore safety and tolerability ...

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/52/NCT04413552/ICF_000.pdf

Protocol No. INDV-2000-101 Sponsor Indivior Part 1

A safety review of data collected from the first subgroup will be done to ensure that it is safe to continue with the second subgroup. At least one day after, ...