None listed
Conditions
Brief summary
This is a prospective, randomised, openlabel, activecontrolled, multicenter trial comparing treatment effects of CAM2038 (BPN depot injection) with BPN standard of care (for example, sublingual [SL] BPN or BPN/naloxone [BPN/NX]) in adult outpatients with opioid dependence. Opioid dependent patients who are either currently receiving medication assisted treatment (MAT) with SL BPN or BPN/NX, or patients who are actively seeking BPN standard of care treatment but who have not yet begun a treatment regimen, may be eligible for the trial. Patients will be randomised in a 1:1 ratio to either CAM2038 (involving either weekly or monthly depot injections based upon prescriber and patient choice) or BPN standard of care MAT. Stratification by new to treatment will be applied. The trial will consist of a Screening Period of up to 4 weeks duration, a Treatment Period of 24 weeks duration, and a Followup Period of 2 weeks duration. Outcomes relevant to study include the treatments’ perspective impact on patient’s satisfaction of treatment and other patient reported outcomes (PROs), as well as understanding the potential health economic impact and resource utilization with CAM2038 treatment.
Interventions
CAM2038 uses a unique, low viscosity, lipidbased FluidCrystal® injection depot
technology containing dissolved buprenorphine (BPN) and is subcutaneously (SC) administered (alternated between the different injection areas i.e., the buttock, thigh, abdomen, or upper arm) by healthcare professionals at weekly (CAM2038 once weekly [q1w]) or monthly (CAM2038 once monthly [q4w]) intervals. Patients receiving CAM2038 can be switched between the weekly and monthly products at any time during the entire
CAM2038 uses a unique, low viscosity, lipidbased FluidCrystal® injection depot technology containing dissolved buprenorphine (BPN) and is subcutaneously (SC) administered (alternated between the different injection areas i.e., the buttock, thigh, abdomen, or upper arm) by healthcare professionals at weekly (CAM2038 once weekly [q1w]) or monthly (CAM2038 once monthly [q4w]) intervals. Patients receiving CAM2038 can be switched between the weekly and monthly products at any time during the entire trial at the discretion of the treating Investigator. The treatment duration is 24 weeks.
Sponsors
Camurus AB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult male or female patient (18 years or older) Meet the criteria for opioid dependence as defined by either the criteria for moderate to severe opioid use disorder in the Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) OR opioid dependence in the International Statistical Classification of Diseases and Related Health Problems – 10th Edition (ICD-10) according to local practice. Appropriate candidate for MAT with a partial opioid agonist as determined by the Investigator and is willing to continue in BPN treatment for the duration of the trial.
Exclusion criteria
Requires chronic use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4) such as some azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. clarithromycin), or protease inhibitors (e.g. ritonavir, indinavir, and saquinavir). Hypersensitivity or intolerance to BPN or NX or any related drug. Having a contraindicated serious medical condition including unstable and severe pain in the opinion of the investigator. Clinically significant laboratory and ECG abnormalities. Recent history of significant suicidal ideation or active suicidal behavior, in the opinion of the Investigator. Participants with serious untreated psychiatric comorbidity at the discretion of the Investigator.
Outcome results
None listed