INDV-2000 for Opioid Use Disorder

Recruiting at 30 trial locations

Overseen By Rishi Kakar, MD

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug INDV-2000 different from other opioid use disorder treatments?

The drug INDV-2000, also known as C4X3256, is unique because it may involve a novel mechanism of action targeting delta-opioid receptors, unlike traditional treatments that focus on mu-opioid receptors. This could potentially offer a different approach to managing opioid use disorder by modulating different pathways in the brain. ^{1 2 3 4 5}

Research Team

Global Director Clinical Development

Principal Investigator

Indivior Inc.

Eligibility Criteria

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

I am between 18 and 65 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gaps in Evidence-based Treatment of Concurrent Attention Deficit Hyperactivity Disorder and Opioid Use Disorder: A Scoping Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Improving naltrexone compliance and outcomes with putative pro- dopamine regulator KB220, compared to treatment as usual. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Naltrexone Implant for Opioid Use Disorder. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Central effects of a selective delta-opioid receptor antagonist, ICI 174864. [2013]

5. Netherlands 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. [2020]