InSite Clinical Research | DeSoto, TX
Status and phase
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Treatments
About
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.
Full 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.
Enrollment
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Volunteers
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 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:
The participant recently completed medically supervised withdrawal outside of the study, and:
Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication.
Female participant of non-childbearing potential; or a female 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, she is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1, and she is not lactating.
Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive).
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 1 time per week.
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.
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.
Serious cardiac illness or other cardiac assessments including, but not limited to:
Have any combination of the following at screening:
Current symptomatic hepatic or biliary disease, including participants with cholecystectomy <90 days prior to Screening.
Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to signing the informed consent form.
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).
Known allergy or hypersensitivity to IMP or its excipients.
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.
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 (i.e., site staff, Indivior, or Clinical Research Organization [CRO] employee).
Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements.
Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.
Primary purpose
Allocation
Interventional model
Masking
300 participants in 4 patient groups, including a placebo group
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Central trial contact
Global Director Clinical Development
Data sourced from clinicaltrials.gov
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