A Phase II Double Blind, Placebo Controlled, Randomised, Dose-Ranging Study to Assess the Safety and Efficacy of INDV-2000 Over 3 Months in Treatment Seeking Individuals With Opioid Use Disorder

Indivior Inc.35 sites in 1 country300 target enrollmentJune 10, 2024

ConditionsOpioid Use Disorder

InterventionsINDV-2000 Placebo

Overview

Phase: Phase 2
Intervention: INDV-2000
Conditions: Opioid Use Disorder
Sponsor: Indivior Inc.
Enrollment: 300
Locations: 35
Primary Endpoint: Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85).
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

From Day 1 to Day 7, TM buprenorphine and randomized INDV-2000/Placebo will be administered, INDV-2000/Placebo will be administered alone from Day 8 onward. The randomized treatment period starts when the participant receives randomized treatment (at Day 1) and ends at his/her last study visit, if on INDV-2000/Placebo alone, or ends when starting buprenorphine rescue therapy.

Registry

clinicaltrials.gov

Start Date

June 10, 2024

End Date

November 3, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Indivior Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed consent.
•Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
•Males or females with moderate or severe opioid use disorder (OUD) by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who are looking to transition from daily short-term opioid agonist treatment (medically supervised withdrawal) to non-opioid treatment.
•Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below.
•The participant will initiate, or is undergoing medically supervised withdrawal, and
•In the opinion of the investigator, the participant is able to achieve a stable dose of transmucosal (TM) buprenorphine between ≤24 mg inclusive prior to randomization.
•Current opioid agonist treatment does not exceed 35 days from the start of TM buprenorphine to the end of Screening window.
•The participant recently completed medically supervised withdrawal outside of the study, and
•Time elapsed between last dose of TM buprenorphine or other withdrawal medication and Study Day 1/randomization does not exceed 21 calendar days.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
•Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
•Meet DSM-5 criteria for severe substance use disorder other than opioids.
•Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder that would impact participation in the study as judged by an Investigator or medically responsible physician.
•Had an opioid overdose event within the 6 months prior to the Screening Visit.
•Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
•Have clinically significant abnormal biochemistry, hematology or urinalysis results that would impact participation in the study as judged by an Investigator or medically responsible physician.
•Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
•Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.

Arms & Interventions

200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets

Intervention: INDV-2000

100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets

Intervention: INDV-2000

400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets

Intervention: INDV-2000

Placebo dose

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85).

Time Frame: 12 weeks

The treatment failure is defined as meeting either one of the two criteria. 1. Urine Drug Screen (UDS, dipstick) positive for opioids, or fentanyl on 4 consecutive assessments while participants on the Investigational Medicinal Product (IMP) (INDV-2000 or placebo) alone (after Day 8 visit). 2. Discontinued the IMP (INDV-2000 or placebo) prematurely.

Secondary Outcomes

Participant's percentage of visits with opioid abstinence during the whole study follow-up.(13 Weeks)
Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths.(17 weeks)
Proportion (probability) of visits with opioid abstinence while participants are on IMP alone.(From Week 1 to Week 13)
AUC0-24 on Day 1 and Day 15/16(2 Weeks)
Cavg on Day 1 and Day 15/16(2 Weeks)
Cmin on Day 1 and Day 15/16(2 Weeks)
CL/F on Day 1 and Day 15/16(2 Weeks)
Clinical Opiate Withdrawal Scale (COWS) score(4 weeks)
Cmax on Day 1 and Day 15/16(2 Weeks)
Opioid Craving Assessment(13 Weeks)
Tmax on Day 1 and Day 15/16(2 Weeks)