Extended-release Pharmacotherapy for Opioid Use Disorder
Summary
The primary objective is a clinical superiority effectiveness contrast to standard of care. Reported following SPIRIT and CONSORT standards, the study will determine whether extended-release injectable depot Buprenorphine (XR-Bup) maintenance therapy for OUD over six months is clinically superior to standard-of-care, oral medication (sublingual Buprenorphine \[SL-Bup\] or oral methadone \[Met\]; together: Bup/Met)
Timeline
- Start
- 2019-08-06
- Primary completion
- 2022-04-29
- Completion
- 2023-03-01
Outcome
Met primary endpoint
paper adjusted mean of 123.43 days (SE 4.76; range: 24-161 days) in the BUP-XR group (adjusted incident rate ratio [IRR] 1.18, 95% confidence interval [CI] 1.05-1.33; p-value 0.004). PMID 38045803 ↗
paper monthly BUP-XR is clinically superior, delivering greater abstinence from opioids PMID 38045803 ↗
Publications
- Background Marsden J, Kelleher M, Hoare Z, Hughes D, Bisla J, Cape A, Cowden F, Day E, Dewhurst J, Evans R, Hearn A, Kelly J, Lowry N, McCusker M, Murphy C, Murray R, Myton T, Quarshie S, Scott G, Turner S, Vanderwaal R, Wareham A, Gilvarry E, Mitcheson L. 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. Trials. 2022 Aug 19;23(1):697. doi: 10.1186/s13063-022-06595-0.
- Results Marsden J, Kelleher M, Gilvarry E, Mitcheson L, Bisla J, Cape A, Cowden F, Day E, Dewhurst J, Evans R, Hardy W, Hearn A, Kelly J, Lowry N, McCusker M, Murphy C, Murray R, Myton T, Quarshie S, Vanderwaal R, Wareham A, Hughes D, Hoare Z. Superiority and cost-effectiveness of monthly extended-release buprenorphine versus daily standard of care medication: a pragmatic, parallel-group, open-label, multicentre, randomised, controlled, phase 3 trial. EClinicalMedicine. 2023 Nov 17;66:102311. doi: 10.1016/j.eclinm.2023.102311. eCollection 2023 Dec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 100 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 300 mg | Subcutaneous |
| Comparator | Methadone | Other / unclassified | — | Oral |
Indications
No indication recorded.