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Opioid Receptor Modulator

INDV-6001 for Opioid Use Disorder

Phase 2

Recruiting

Research Sponsored by Indivior Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

2. Adults (male or female) between the ages of 18 and 65 years, inclusive, at the time of signing the ICF.

1. Cohorts 1-4: Currently meets or has documented history of moderate or severe opioid use disorder (OUD) as per DSM-5 criteria; can be dose adjusted to 12-16 mg SUBOXONE once a day (QD) or currently taking transmucosal buprenorphine (TM BUP) for OUD and can be dose adjusted to 12 to 16 mg SUBOXONE QD;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 260 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well and how safe INDV-6001 is when taken multiple times by people with opioid use disorder. The study will also look at different ways of giving the medication, like

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site, general discomfort, potential changes in mood or behavior due to medication adjustments, and other typical opioid withdrawal symptoms as participants transition between treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a moderate or severe opioid addiction and can adjust my treatment to 12-16 mg of SUBOXONE daily.

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I agree not to use any buprenorphine products except for those given in this study.

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I am postmenopausal with an FSH level over 30 mIU/mL.

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I am permanently sterilized.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 260 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 260 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 260 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection

Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection

Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection

+4 more

Secondary study objectives

Assessment of the safety and tolerability of INDV-6001 injection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 6Experimental Treatment2 Interventions

SUBLOCADE 300 mg, followed by INDV-6001 (600 mg on Day 29, Day 85 and Day 141)

Group II: Cohort 5Experimental Treatment2 Interventions

SUBLOCADE 100 mg, followed by INDV-6001 (600 mg on Day 29 and Day 113)

Group III: Cohort 4Experimental Treatment2 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 3Experimental Treatment2 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 V: Cohort 2Experimental Treatment2 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 VI: Cohort 1Experimental Treatment2 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Suboxone

2008

Completed Phase 3

~290

Sublocade

2019