COMPLETED

Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-10

Study Completion:2025-11-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06384157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants are eligible to be included in the study only if all of the following criteria apply: 1. 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. 2. 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. 3. 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. 4. Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below. 1. 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. 2. 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. * Recently completed opioid agonist treatment does not exceed 35 days of TM buprenorphine dosing days inclusive of medically assisted withdrawal dosing. 5. Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable forms of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: established use of oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide), or abstinence. 6. A female participant of non-childbearing potential, or a male of childbearing potential if * She agrees to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: abstinence; established use or oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide). * She is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1. * She is not lactating. 7. Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive)	* Participants are excluded from the study if any of the following criteria apply: 1. Have a current diagnosis, other than OUD, requiring chronic opioid treatment. 2. Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders. 3. Meet DSM-5 criteria for severe substance use disorder other than opioids. 4. 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. 5. Had an opioid overdose event within the 6 months prior to the Screening Visit. 6. Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening. 7. 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. 8. Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea. 9. Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes. 10. History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent. 11. Serious cardiac illness or other cardiac assessments including, but not limited to: * Uncontrolled arrhythmias. * History of congestive heart failure. * Myocardial infarction \<6 months from receipt of first dose of investigational medicinal product (IMP) * Uncontrolled symptomatic angina * QT interval corrected with Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome. 12. Have any combination of the following at screening: * Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin \>1.3 mg/dL), * Alanine aminotransferase (ALT) ≥3×ULN * Aspartate aminotransferase (AST) ≥3×ULN * International normalized ratio (INR) \>1.2 for participants not receiving anticoagulation therapy, \>3.0 for participants on conventional coagulation therapy, \>3.5 for participants on intensive anticoagulation, or * Estimated glomerular filtration rate \<60 mL/min by Cockroft-Gault formula. 13. Current symptomatic hepatic or biliary disease, including participants with cholecystectomy \<90 days prior to Screening. 14. Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively. 15. Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to the signing the informed consent form. 16. Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (\<11 g/dL for females, \<12 g/dL for males). 17. Known allergy or hypersensitivity to IMP or its excipients. 18. Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results. 19. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff, Indivior, or Clinical Research Organization \[CRO\] employee). 20. Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements, including prohibited concomitant therapies. 21. Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.

Inclusion Criteria

Exclusion Criteria

* Participants are eligible to be included in the study only if all of the following criteria apply:
1. 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.
2. 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.
3. 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.
4. Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below.
1. 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.
2. 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.
* Recently completed opioid agonist treatment does not exceed 35 days of TM buprenorphine dosing days inclusive of medically assisted withdrawal dosing.
5. Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable forms of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: established use of oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide), or abstinence.
6. A female participant of non-childbearing potential, or a male of childbearing potential if
* She agrees to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication. The following methods of contraception are considered to be medically acceptable: abstinence; established use or oral, injected or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a double barrier method of contraception (condom or occlusive cap with use of a spermicide).
* She is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1.
* She is not lactating.
7. Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive)

* Participants are excluded from the study if any of the following criteria apply:
1. Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
2. Have a concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
3. Meet DSM-5 criteria for severe substance use disorder other than opioids.
4. 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.
5. Had an opioid overdose event within the 6 months prior to the Screening Visit.
6. Uses any substance of abuse via the injection route more than 2 times per week over the last 3 months prior to Screening.
7. 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.
8. Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
9. Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
10. History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
11. Serious cardiac illness or other cardiac assessments including, but not limited to:
* Uncontrolled arrhythmias.
* History of congestive heart failure.
* Myocardial infarction \<6 months from receipt of first dose of investigational medicinal product (IMP)
* Uncontrolled symptomatic angina
* QT interval corrected with Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome.
12. Have any combination of the following at screening:
* Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin \>1.3 mg/dL),
* Alanine aminotransferase (ALT) ≥3×ULN
* Aspartate aminotransferase (AST) ≥3×ULN
* International normalized ratio (INR) \>1.2 for participants not receiving anticoagulation therapy, \>3.0 for participants on conventional coagulation therapy, \>3.5 for participants on intensive anticoagulation, or
* Estimated glomerular filtration rate \<60 mL/min by Cockroft-Gault formula.
13. Current symptomatic hepatic or biliary disease, including participants with cholecystectomy \<90 days prior to Screening.
14. Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
15. Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to the signing the informed consent form.
16. Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (\<11 g/dL for females, \<12 g/dL for males).
17. Known allergy or hypersensitivity to IMP or its excipients.
18. Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results.
19. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff, Indivior, or Clinical Research Organization \[CRO\] employee).
20. Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements, including prohibited concomitant therapies.
21. Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.

Contacts and Locations

Principal Investigator

Global Director Clinical Development

STUDY_DIRECTOR

Indivior Inc.

Study Locations (Sites)

Boyett Health Services Inc

Hamilton, Alabama, 35570

United States

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018

United States

North County Clinical Research

Oceanside, California, 92054

United States

Empire Clinical Research

Pomona, California, 91767

United States

Artemis Institute For Clinical Research - San Diego

San Diego, California, 92103

United States

Imagine Research of Palm Beach County

Boynton Beach, Florida, 33435

United States

Bold City Clinical Research

Jacksonville, Florida, 32224

United States

Vitalix Kissimmee

Kissimmee, Florida, 34741

United States

Accel Research Sites - Lakeland

Lakeland, Florida, 33803

United States

Quantum Clinical Trials

Miami Beach, Florida, 33140

United States

Segal Trials Miami Lakes

Miami Lakes, Florida, 33016

United States

Clinical Research Center of Florida

Pompano Beach, Florida, 33060

United States

Agile Clinical Research Trials

Atlanta, Georgia, 30328

United States

Maryland Treatment Centers

Baltimore, Maryland, 21229

United States

Vitalix Clinical

Worcester, Massachusetts, 01608

United States

Insight Research Institute

Flint, Michigan, 48507

United States

Precise Research Centers

Flowood, Mississippi, 39232

United States

Arch Clinical Trials

St Louis, Missouri, 63141

United States

IMA Clinical Research

Las Vegas, Nevada, 89102

United States

Oasis Clinical Research

Las Vegas, Nevada, 89121

United States

Richmond Behavioral Associates

Staten Island, New York, 10314

United States

Dr Vando Medical Services

The Bronx, New York, 10464

United States

Monroe Biomedical Research

Monroe, North Carolina, 28112

United States

West Clinical Research

Morehead City, North Carolina, 28557

United States

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417

United States

Pahl Pharmaceutical Professionals, LLC

Oklahoma City, Oklahoma, 73112

United States

SP Research PLLC Rivus Wellness and Research Insitute

Oklahoma City, Oklahoma, 73112

United States

Unity Clinical Research

Oklahoma City, Oklahoma, 73118

United States

Prisma Health Addiction Medicine Center

Greenville, South Carolina, 29605

United States

Insite Clinical Research, LLC

DeSoto, Texas, 75115

United States

El Paso Clinical Trials

El Paso, Texas, 79902

United States

HD Research

Houston, Texas, 77043

United States

Progressive Clinical Research Llc

Bountiful, Utah, 84010

United States

Alpine Research Organisation

Clinton, Utah, 84015

United States

Boeson Clinical Research

Provo, Utah, 84604

United States

Collaborators and Investigators

Sponsor: Indivior Inc.

Global Director Clinical Development, STUDY_DIRECTOR, Indivior Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10

Study Completion Date2025-11-03

Study Record Updates

Study Start Date2024-06-10

Study Completion Date2025-11-03

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use Disorder