Official websites use. Share sensitive information only on official, secure websites. CAM weekly 8, 16, 24 or 32 mg or monthly 64, 96, or mg with flexible dosing and individualized titration utilizing multiple CAM weekly and monthly doses. Participants were administered a patient satisfaction survey at months 6 and 12, completed by of The study treatment period was completed by of Most of the TEAEs, reported by of Five participants 2.
No serious adverse events were attributed to the study drug. Participants reported high levels of satisfaction with CAM Subcutaneous buprenorphine delivered weekly or monthly CAM was well tolerated, with a systemic safety profile consistent with the known profile of sublingual buprenorphine. CAM weekly and monthly was associated with high retention rates and low levels of illicit opioid use throughout this study.
Opioid use disorder is a chronic, relapsing disorder causing significant mental, physical and social problems, including transmission of infectious diseases, unintentional overdose and criminal activity 5 , 6 , 7. Additionally, supervised administration of SL BPN, if applied, increases the cost and inconvenience of treatment for service providers and patients. The injection depot is engineered to immediately and spontaneously start to form a matrix for extended release of BPN upon exposure to the subcutaneous environment.
Effectiveness unsanctioned substance use, withdrawal and craving measures and treatment retention were assessed as secondary outcomes. The study was approved by the Institutional Review Board in the United States or national equivalent at respective countries and conducted in compliance with Good Clinical Practice regulations and guidelines, the ethical principles originated from the Declaration of Helsinki, the International Council for Harmonisation guidance, and all applicable local regulations.
Signed informed consent forms were obtained from each participant before undergoing any study procedure. Additional exclusion criteria are provided in the Supporting information. Investigators could titrate doses and adjust dosing intervals weekly or monthly as needed for each participant. Participants were allowed dose adjustments as needed with CAM weekly at scheduled visits or with 8 mg CAM SC supplemental injections at unscheduled visits up to a maximum weekly dose of 40 mg per week. Participants who needed additional temporary buprenorphine were allowed a maximum of two supplemental injections of 8 mg CAM weekly per week; dose adjustments could be made at investigator discretion at scheduled visits.
