INDV-2000 for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
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.12345
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
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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.
See 15 more
Trial 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 (Other)
Trial OverviewThe 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
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 400 mg INDV-2000 QD dosed by two 200 mg extended-release tabletsExperimental Treatment1 Intervention
Group II: 200 mg INDV-2000 QD dosed by two 100 mg extended-release tabletsExperimental Treatment1 Intervention
Group III: 100 mg INDV-2000 QD dosed by two 50 mg extended-release tabletsExperimental Treatment1 Intervention
Group IV: Placebo dosePlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
North County Clinical ResearchOceanside, CA
Oasis Clinical ResearchLas Vegas, NV
Richmond Behavioral AssociatesStaten Island, NY
Empire Clinical ResearchPomona, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Indivior Inc.Lead Sponsor
References
Gaps in Evidence-based Treatment of Concurrent Attention Deficit Hyperactivity Disorder and Opioid Use Disorder: A Scoping Review. [2023]To describe the effectiveness of medications for the treatment of opioid use disorder (OUD) and attention deficit/hyperactivity disorder (ADHD).
Improving naltrexone compliance and outcomes with putative pro- dopamine regulator KB220, compared to treatment as usual. [2022]A recent analysis from Stanford University suggested that without any changes in currently available treatment, prevention, and public health approaches, we should expect to have 510,000 deaths from prescription opioids and street heroin from 2016 to 2025 in the US. In a recent review, Mayo Clinic Proceedings (October 2019), Gold and colleagues at Mayo Clinic reviewed the available medications used in opioid use disorders and concluded that in private and community practice adherence is more important as a limiting factor to retention, relapse, and repeat overdose. It is agreed that the primary utilization of known opioid agonists like methadone, buprenorphine and naloxone combinations, while useful as a way of reducing societal harm, is limited by 50% of more discontinuing treatment within 6 months, their diversion, and addiction liability. Opioid agonists may have other unintended consequences, like continuing the down regulation of dopamine systems. While naltrexone would be expected to have opposite effects, adherence is also low even after detoxification and long acting naltrexone injections. Recent studies have shown Naltrexone is beneficial by attenuation of craving via "psychological extinction" and reducing relapse. Buprenorphine is the MAT of choice currently but injectable Naltrexone plus an agent to improve dopaminergic function and tone may renew interest amongst addiction physicians and patients. Understanding this dilemma there is increasing movement to opt for the non-addicting narcotic antagonist Naltrexone. Even with extended injectable option there is still poor compliance. As such, we describe an open label investigation in humans showing improvement of naltrexone compliance and outcomes with dopamine augmentation with the pro- dopamine regulator KB220 (262 days) compared to naltrexone alone (37days). This well studied complex consists of amino-acid neurotransmitter precursors and enkephalinase inhibitor therapy compared to treatment as usual. Consideration of this novel paradigm shift may assist in not only addressing the current opioid epidemic but the broader question of reward deficiency in general.
Naltrexone Implant for Opioid Use Disorder. [2022]The continued rise in the availability of illicit opioids and opioid-related deaths in the United States has left physicians, researchers, and lawmakers desperate for solutions to this ongoing epidemic. The research into therapeutic options for the treatment of opioid use disorder (OUD) began with the introduction of methadone in the 1960s. The approval of oral naltrexone initially showed much promise, as the drug was observed to be highly potent in antagonizing the effects of opioids while producing no opioid agonist effects of its own and having a favorable side effect profile. Patients that routinely take their naltrexone reported fewer days of heroin use and had more negative drug tests than those without treatment. Poor outcomes in OUD patients treated with naltrexone have been directly tied to short treatment time. Studies have shown that naltrexone given orally vs. as an implant at the 6-month interval showed a higher non-compliance rate among those who used oral medications at the 6-month mark and a slower return to use rate. There were concerns that naltrexone could possibly worsen negative symptoms seen in opiate use disorder related to blockade of endogenous opioids that are important for pleasurable stimuli. Studies have shown that naltrexone demonstrated no increase in levels of anxiety, depression and anhedonia in participants and another study found that those treated with naltrexone had a significant reduction in mental health-related hospitalizations. The latter study also concluded that there was no increased risk for mental health-related incidents in patients taking naltrexone via a long-acting implant. Although not yet FDA approved in the United States, naltrexone implant has shown promising results in Europe and Australia and may provide a novel treatment option for opioid addiction.
Central effects of a selective delta-opioid receptor antagonist, ICI 174864. [2013]Leu-enkephalin (LENK) injected intracerebroventricularly (icv) in a dose of 50-400 micrograms to male Wistar rats inhibited their open field locomotor activity. This effect was antagonized by 1 microgram icv of ICI 174864 but not by naloxone (NAL). Doses of 5 and 10 micrograms of ICI 174864 icv induced a characteristic abnormal behavioral syndrome, which was inhibited by icv LENK, but not by morphine. ICI 174864 potentiated the analgesic effect of morphine, whereas NAL inhibited it. The results indicate that ICI 174864 is an antagonist of central delta-opioid receptors. The abnormal behavior induced by higher doses of ICI 174864 is suggested as an experimental model for studying the central delta-opioid receptors.
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]Untreated opioid addiction in people with HIV is associated with poor HIV treatment outcomes. Slow-release, long-acting, implantable naltrexone might improve these outcomes. Here, we present results of a study aimed to test this hypothesis.