The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)

INTERVENTION: 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. CONDITION: Mental Health ‐ Addiction Opioid dependent; ; Opioid dependent PRIMARY OUTCOME: Objective: To compare patient satisfaction with CAM2038 to buprenorphine (BPN) standard of care in adult outpatients with opioid dependence.; Endpoint: Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction score.[TSQM performed at Baseline (Day 1), Week 4, Week 12, Week 24, and Premature Discontinuation.] SECONDARY OUTCOME: Objective: To assess patient satisfaction with treatment. ; Endpoint: ; TSQM effectiveness score ; TSQM side effects score ; TSQM convenience score ; Patient satisfaction visual analogue scale (VAS)[TSQM and Patient satisfaction VAS performed at Baseline (Day 1), Week 4, Week 12, Week 24, and Premature Discontinuation.] Objective: To assess the effect on treatment related behaviours and perception of treatment. ; Endpoint: Treatment Burden Questionnaire (TBQ) ; Opioid Related Behaviours In Treatment (ORBIT) scale. ; ; This is a composite secondary outcome.[TBQ and ORBIT performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation.] Objective: To assess the safety and tolerability of CAM2038. ; Endpoint: AEs. ; At every clinic visit, patients will be asked a standard question to elicit any medically related changes in their well‐being. They will also be asked if they have been hospitalised, had any accidents, used any new medications, or changed concomitant medication regimens (both prescription and over‐the‐counter medications).[AEs collected at Screening, Baseline (Day 1), every month for 24 weeks post Baseline (Day 1), every other visit where trial treatment is administered, Premature Discontinuation, and Week 26 (follow up).] Objective: To assess treatment effects of measures of general physical, mental and psychosocial functioning. ; Endpoint: Short Form 36 (SF‐36) ; Depression, Anxiety and Stress Scale 21 (DASS‐21). ; ; This is a composite secondary outcome[SF‐36 and DASS‐21 performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation.] Objective: To assess treatment effects on adherence to medication. ; Endpoint: Trial drug adherence measured by dispensing records (for CAM2038) and self‐reports of drug accountability (for BPN standard of care).[Monthly for 24 weeks from Baseline (Day 1).] Objective: To assess treatment effects on criminal activity. ; Endpoint: Criminal offences and incarcerations during the trial (AD‐SUS questionnaire).[AD‐SUS performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation.] Objective: To assess treatment effects on diversion and misuse of the trial medications. ; Endpoint: Self‐reported diversion and misuse of the trial medications using ORBIT (for BPN standard of care) ; Self‐reported overdoses.[ORBIT performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation. ; Endpoint: ; Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) ; Estimates of health care resource utilization (HRU) through modified Alcohol & Drug adapted Adult Service Use Schedule (AD‐SUS) questionnaire ; Self‐reported overdoses performed every 4 weeks for 24 weeks post Baseline (Day 1), and Premature Discontinuation.] Objective: To assess treatment effects on health economic outcomes (HEOs) including treatment utilization. ; Estimates of social service utilisation (AD‐SUS questionnaire) ; Estimation of quality‐adjusted life years (QALYs). ; ; This is a composite secondary outcome[WPAI:GH, AD‐SUS and QALYs performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation.] Objective: To assess treatment effects on illicit drug use other than opioids. ; Endpoint: Illicit drug use measured by UDS and self‐reports of drug use by Australian Treatment Outcomes Profile (ATOP).[UDS and ATOP performed at Screening, Baseline (Day 1), every 4 weeks for 24 weeks post Baseline (Day 1), and Premature Discontinuation.] Objective: To assess treatment effects on illicit, non‐prescribed and unsanctioned prescribed use of opioids. ; Endpoint: Illicit opioid drug use measured by urine drug screen (UDS) and self‐reports of illicit opioid drug use by timeline follow‐back method (TLFB). ; [UDS and TLFB performed at Screening, Baseline (Day 1), every 4 weeks for 24 weeks post Baseline (Day 1), and Premature Discontinuation.] Objective: To assess treatment effects on opioid cravings. ; Endpoint: Craving visual analogue scale (Craving VAS).[Craving VAS performed at Baseline (Day 1), Week 4, Week 12, Week 24, and Premature Discontinuation.] Objective: To assess treatment effects on opioid withdrawal symptoms. ; Endpoint: Clinical Opiate Withdrawal Scale (COWS).[COWS performed at Baseline (Day 1), Week 4, Week 12, Week 24, and Premature Discontinuation.] Objective: To assess treatment effects on quality of life and patient functioning. ; Endpoint: ; Substance Use Recover Evaluator (SURE) ; EuroQol five dimensions health questionnaire (EQ‐5D) ; Opioid Substitution Treatment Quality of Life Scale (OSTQOL) ; Patient Global Impression of Change (PGIC). ; ; This is a composite secondary outcome.[SURE, EQ‐5D and OSTQOL performed at Baseline (Day 1), Week 12, Week 24, and Premature Discontinuation. ; PGIC performed at Week 12, Week 24, and Premature Discontinuation. ; ] Objective: To assess treatment effects on retention in treatment. ; Endpoint: Retention in treatment.[Retention in treatment is calculated as days in treatment since randomization until the last day of medication during the 24 weeks of treatment (plus the respective duration of CAM2038 q1w, CAM2038 q4w or BPN standard of care).] 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.