Primary objective | Primary endpoint |
1. To examine extended-release buprenorphine BUP-XR) treatment retention at 48 weeks | 1.1 Proportion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections. Treatment retention is defined as remaining on active depot buprenorphine medication at 48 weeks. |
Secondary objective | Secondary endpoint |
1. To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks | 1.1 Proportion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks. |
2. To evaluate opioid craving, withdrawal, opioid and other drug use | 2.1 Change in clinically assessed (urinary drug screen) and client-reported use of opioids 2.2 Change in clinically assessed (urinary drug screen) and client-reported use of other drugs 2.3 Change in clinically assessed opioid craving |
3. To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule and dose supplementation | 3.1 Percentage of participants who completed 12 injections (per protocol) during the 48 week study period. 3.2 Percentage of participants requiring dose adjustments with sublingual buprenorphine/buprenorphine-naloxone (and dose) during treatment 3.3 Percentage of participants maintained on 300 mg per month and 100 mg per month after the initial 2×300 mg injection 3.4 Mean duration of continuous treatment (weeks) 3.5 Reasons for drop-out among non-completers 3.6 Percentage of participants presenting to receive treatment within 7 and 14 days of the next scheduled injection 3.7 Mean duration (days) between administered injections |
4. To evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug–drug interactions and pain management in clients treated with BUP-XR | 4.1 Percentage of participants with different types of ‘special events of interest’ 4.2 Percentage of participants with common adverse events (reported in greater than 5%) 4.3 Percentage of participants with at least one severe or potentially life threatening (grade 3 or 4) adverse event; 4.4 Percentage of participants withdrawn from treatment due to unacceptable adverse events |
5. To describe client-reported changes to health and social well-being | 5.1. Health service utilisation during treatment and estimated costs (including client travel) 5.2. Hours worked in paid employment/study 5.3. Other changes in health and social well-being (as measured by PEG, AQol-4D, ATOP client surveys) |
6. To evaluate demographic, drug use and treatment factors associated with treatment outcomes | 6.1 Demographic, drug use and treatment characteristics associated with treatment outcomes, for example, participant retention |
7. To evaluate client-reported experience of treatment | 7.1 Client-reported treatment satisfaction measures |
8. To examine BUP-XR treatment retention at 24 weeks | 8.1 Percentage of participants retained in treatment at 24 weeks following initiation of monthly depot buprenorphine injections. Treatment retention is defined as remaining on active depot buprenorphine medication at 24 weeks. |
9. To document the cost of the treatment at different settings | 9.1 Using process measures identify the resource use at both client and facility level |
AQoL-4D, Australian Quality of Life four-dimension; ATOP, Australian Treatment Outcome Profile; CoLAB, Community studies of Long-Acting Buprenorphine; PEG, Pain, Enjoyment, General Activity.