Opioid use disorder Mental and Behavioural Disorders
Conditions
Interventions
Participants will have 3 study sessions. In each study session, they’ll take their prescribed dose of methadone, and then either a low dose (100 mg) or high dose (600 mg) of study medicine, or placebo
Sponsors
Indivior Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males or females with a diagnosis of OUD who are clinically stable with no new signs or symptoms for at least 1 month on take-home methadone treatment with no dose increase in the last 10 days prior to screening; 2. Agreed 18 – 65 years of age, inclusive; 3. BMI of 18.0 to 35.0 kg/m², inclusive (minimum weight of at least 50.0 kg at Screening); 4. Males who are sexually active with individuals who are of childbearing potential, and females who are of childbearing potential, must agree to use at least one medically acceptable form of contraception; 5. Females of childbearing potential must not be pregnant as confirmed by a negative serum and/ or urine hCG test at screening; 6. Females of childbearing potential must not be lactating; and 7. Participants must be able to give written consent (including verbalise understanding of the consent form); be willing and likely to complete all study procedures; be able to comply with the protocol requirements and site procedures
Exclusion criteria
Exclusion criteria: 1. Take over 120 mg/day of prescribed methadone; 2. Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder (current severe mental health disorder excluding opiate dependence) as judged by an Investigator 3. Use regular prescription medications which in the opinion of the investigators will interfere with participant safety or study integrity. Regular use of psychotropic medication will be permitted e.g., antidepressants, provided the participant is compliant with administration and the investigators concur that they will not interfere with participant safety or study integrity 4. Have clinically significant abnormal biochemistry, haematology or urinalysis results 5. Have a history of narcolepsy, cataplexy or obstructive or central sleep apnoea 6. Have disorders that may interfere with drug ADME processes 7. Tests positive for HIV-1/HIV-2 antibodies, and/or has serological evidence of active Hepatitis B or Hepatitis C infection 8. Have serious cardiac illness or other cardiac assessments including, but not limited to: 8.1. Uncontrolled arrhythmias 8.2. History of congestive heart failure (CHF) 8.3. Myocardial infarction in the last 6 months 8.4. Uncontrolled symptomatic angina 8.5. QTcF > 460 ms for males and >480 ms for females or history of prolonged QT syndrome 9. Have current active hepatic or biliary disease, including participants with cholecystectomy 1.3 mg/dL) 18.2 ALT =3x ULN 18.3 AST =3x ULN 18.4 serum creatinine >2x ULN 18.5 or INR >1.2x ULN 19. Have received any prior treatment with a buprenorphine injection at least 1 year prior to randomisation 20. Currently incarcerated or pending incarceration/legal action that could prevent participation or compliance in the study 21. Contraindication to MRI based on the standard MRI screening questionnaire. Contraindications include, but not limited to, certain ferr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameters including the mean blood oxygenation level dependent (BOLD) signal of the (cue minus neutral) contrast across the voxels in the region of interest (ROI). For each voxel in ROI, the BOLD signal of the (cue minus neutral) contrast is an averaged difference between cue and neutral in arbitrary unit (a beta value) over the time when the participants viewing cue images vs neutral images in a single CR task run. Responses will be measured using MRI scans (BOLD signal) and cue administration tasks on days 1,8, and 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability will be assessed by measuring the adverse events (including incidence, severity, and relatedness of treatment emergent adverse effects (TEAEs), serious adverse events (SAEs), and events leading to discontinuation or death) reported during placebo and individual INDV-2000 dosage treatment period. 2. Effect of INDV-2000 on patient-reported outcomes for craving before and after exposure to salient drug cues will be measured using in-scan difference in opioid craving numerical rating scale (NRS) assessed before and after cue reactive task. 3. Safety and tolerability will be assessed before dosing, at regular intervals up after each dose, and at the subject's final follow-up visit. 4. Cue administration tasks and craving and anxiety NRS will be performed on day 1,8, and 15. | — |
Countries
England, United Kingdom
Contacts
Public ContactUsha Sukumaran
Outcome results
None listed