Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone

Table 1 Dosing schedule for BUP-XR in the study

Dose	Scheduled day	Visit	Window (day)	Dose
1	1	Baseline	-	300mg (loading)
2	28	Week 4	21–42	300mg (loading)
3	56	Week 8	54–70	100mg or 300mg
4	84	Week 12	82–98	100mg or 300mg
5	112	Week 16	110–126	100mg or 300mg
6	140	Week 20	138–168	100mg or 300mg
7>	168>	Week 24> (every 28 days)	Up to 42 days since previous dose	100mg or 300mg

The second 300-mg loading dose of BUP-XR will be given after a minimum of 21 days. The 100-mg maintenance dose can be administered up to 2 days ahead of the schedule (i.e. 26 days since the last injection). Unexpected delays of up to 14 days are not anticipated to have any clinical impact on treatment response, so all subsequent doses can be given up to 14 days after the 28-day scheduled interval (i.e. to 42 days)
BUP-XR, extended-release injectable buprenorphine (RBP6000; Sublocade ®)

ISSN: 1745-6215