INDV-6001 for Opioid Use Disorder

Recruiting at 9 trial locations

Overseen By Eric Chavez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Indivior Inc.

Must be taking: Buprenorphine

Must not be taking: Methadone, Naltrexone, Antiarrhythmics, others

Disqualifiers: Chronic opioid treatment, QT prolongation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.

Will I have to stop taking my current medications?

Participants must not take any buprenorphine-containing products other than those provided in the study. Additionally, they should not be using medications that affect certain liver enzymes (CYP3A4 or CYP2C8) within 30 days before joining the study.

How is the drug INDV-6001 different from other treatments for opioid use disorder?

INDV-6001 is a 3-month long-acting injectable form of buprenorphine, which is unique because it reduces the need for daily medication intake, unlike traditional sublingual buprenorphine or methadone treatments. This extended-release formulation can improve patient comfort and adherence by minimizing the risk of withdrawal and misuse associated with daily dosing. ^{1 2 3 4 5}

What data supports the effectiveness of the drug INDV-6001 for Opioid Use Disorder?

Research shows that long-acting forms of buprenorphine, like the 3-month injectable version, can improve patient comfort and safety by reducing the need for daily medication, which may help prevent treatment dropout and reduce overdose risks. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-65 with moderate to severe opioid use disorder, stabilized on Suboxone or compliant with Sublocade treatment, can join this trial. They must understand and follow the study rules and agree not to take any other buprenorphine products during the trial. Women must be postmenopausal or permanently sterilized.

Inclusion Criteria

My BMI is between 18.0 and 33.0.

I have signed the consent form and can follow the study rules.

I am currently taking SUBLOCADE as prescribed, with regular 4-week injections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Investigational Medicinal Product (IMP) Period

Participants receive SUBOXONE or SUBLOCADE as part of the study until prior to the first INDV-6001 dose

Up to 4 weeks

IMP Period

Participants receive INDV-6001 from the first dose until the end of the study

Up to 260 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INDV-6001

Trial Overview The study tests INDV-6001's effects after multiple doses in patients with opioid use disorder. Participants will first stabilize on Suboxone or transition from a maintenance dose of Sublocade before receiving INDV-6001 at different injection sites.

How Is the Trial Designed?

Group I: Cohort 7 Experimental Treatment 3 Interventions

Participants in Cohort 7 who are new to BUP treatment will undergo rapid induction with SUBLOCADE 300 mg (per product labelling) in the abdomen on Day 1 following an initial dose of SUBOXONE (eg, 4 mg). All participants in Cohort 7 will receive: SUBLOCADE 300 mg (abdomen) on Day 1 and Day 8, SUBLOCADE 100 mg (abdomen) on Day 36, and 600mg INDV-6001 on Day 64.

Group II: Cohort 4a Experimental Treatment 1 Intervention

In Cohort 4, up to 15 participants who reach Day 120 will be enrolled in Cohort 4a. Participants in Cohort 4a will receive an injection of SUBLOCADE 100 mg (abdomen) on Day 120.

Group III: Cohort 4 Experimental Treatment 2 Interventions

SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 100 mg on Day 8, Day 36, Day 64, and Day 92)

Group IV: Cohort 3a Experimental Treatment 1 Intervention

In Cohort 3, up to 15 participants who reach Day 127 will be enrolled into Cohort 3a. Participants in Cohort 3a will receive an injection of SUBLOCADE 300 mg (abdomen) on Day 127.

Group V: Cohort 3 Experimental Treatment 2 Interventions

SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, 600 mg Day 8, followed by 250 mg on Day 15, Day 43, Day 71, and Day 99)

Group VI: Cohort 2a Experimental Treatment 1 Intervention

In Cohort 2, up to 15 participants who reach Day 232 will be enrolled into Cohort 2a. Participants in Cohort 2a will receive an additional injection of INDV-6001 600 mg in the thigh on Day 232.

Group VII: Cohort 2 Experimental Treatment 2 Interventions

SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 64, Day 120, and Day 176)

Group VIII: Cohort 1a Experimental Treatment 1 Intervention

In Cohort 1, up to 15 participants who reach Day 260 will be enrolled into Cohort 1a. Participants in Cohort 1a will receive an additional injection of INDV-6001 600 mg in the back of the upper arm on Day 260.

Group IX: Cohort 1 Experimental Treatment 2 Interventions

SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 92, and Day 176)

Who Is Running the Clinical Trial?

Indivior Inc.

Lead Sponsor

Trials

56

Recruited

11,400+

Published Research Related to This Trial

New prolonged-release formulations of buprenorphine, including a six-month implant and two subcutaneous injection depots, aim to improve patient comfort and safety by reducing the need for daily intake and minimizing risks associated with sublingual forms.

These formulations have shown promise in addressing concerns about treatment adherence, particularly for stabilized patients, while also raising some apprehensions about potential coercive use among opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged-release buprenorphine formulations: Perspectives for clinical practice. Chappuy, M., Trojak, B., Nubukpo, P., et al.[2021]

New prolonged-release formulations of buprenorphine, including a six-month implant and two subcutaneous injection depots, aim to improve patient comfort and safety by reducing the need for daily intake and minimizing risks associated with sublingual forms.

These formulations have shown promise in addressing concerns about treatment adherence, particularly for stabilized patients, while also raising some apprehensions about potential coercive use among opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged-release buprenorphine formulations: Perspectives for clinical practice]. Chappuy, M., Trojak, B., Nubukpo, P., et al.[2022]

Long-acting buprenorphine formulations, including CAM 2038 (Buvidal), RBP-6000 (Sublocade™), and Probuphine™, provide effective options for treating opioid use disorders (OUDs) with varying administration schedules, such as weekly, monthly, or every six months.

These depot and implant formulations enhance patient adherence to treatment by reducing the frequency of dosing compared to traditional oral or sublingual medications, potentially improving overall outcomes in managing OUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. Soyka, M., Franke, AG.[2021]

In 2017, only 38% of substance use treatment facilities in the U.S. offered any medication for opioid use disorder (MOUD), with 62% providing extended-release naltrexone (XR-NTX) but only 3% offering the buprenorphine implant.

The availability of XR-NTX was higher in certain regions and federally-funded facilities, particularly in states with high opioid overdose mortality rates, highlighting a need to improve access to long-acting MOUD options to better address opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of availability of long-acting medication for opioid use disorder. Shover, CL., Humphreys, K.[2020]

In a study involving 570 adults with opioid use disorder, buprenorphine-naloxone was found to be more cost-effective than extended-release naltrexone, being preferred in 97% of cases at 24 weeks and 85% at 36 weeks based on quality-adjusted life-years (QALYs).

The analysis suggests that buprenorphine-naloxone is the better first-line treatment option, especially for patients needing detoxification before starting extended-release naltrexone, although the study had limitations such as a relatively short follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse. Murphy, SM., McCollister, KE., Leff, JA., et al.[2020]

Methadone and buprenorphine are effective first-line treatments for opioid dependence, with new long-acting formulations like CAM 2038 (Buvidal®), RBP-6000 (Sublocade™), and Probuphine™ offering innovative options for maintenance therapy.

These long-acting buprenorphine formulations provide flexibility in treatment schedules, potentially improving adherence and outcomes for individuals with opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New slow-release buprenorphine formulations for optimization of opioid substitution]. Soyka, M., Pogarell, O.[2020]

Citations

1. France pubmed.ncbi.nlm.nih.gov

Prolonged-release buprenorphine formulations: Perspectives for clinical practice. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Prolonged-release buprenorphine formulations: Perspectives for clinical practice]. [2022]

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

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Predictors of availability of long-acting medication for opioid use disorder. [2020]

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

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

[New slow-release buprenorphine formulations for optimization of opioid substitution]. [2020]