Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection

被引:9
|
作者
Hassman, Howard [1 ]
Strafford, Stephanie [2 ]
Shinde, Sunita N. [2 ]
Heath, Amy [2 ]
Boyett, Brent [3 ]
Dobbins, Robert L. [2 ]
机构
[1] Hassman Res Inst, Marlton, NJ USA
[2] Indivior Inc, Richmond, VA USA
[3] Bradford Hlth Serv, Birmingham, AL USA
来源
AMERICAN JOURNAL OF DRUG AND ALCOHOL ABUSE | 2023年 / 49卷 / 01期
关键词
Addiction; craving; opioid use disorder; withdrawal; OPIOID USE DISORDER; DEPOT INJECTION; EFFICACY; OUTCOMES; SAFETY;
D O I
10.1080/00952990.2022.2106574
中图分类号
B849 [应用心理学];
学科分类号
040203 ;
摘要
Background: For patients with opioid use disorder, buprenorphine extended-release injection (BUP-XR) achieves sustained therapeutic plasma concentrations, controls craving and withdrawal symptoms, and improves patient outcomes. Given retention challenges during transmucosal buprenorphine (BUP-TM) induction, assessing methods to quickly achieve sustained buprenorphine concentrations is important. Objectives: This open-label, single-group, single-center pilot study (NCT03993392) evaluated safety and tolerability of initiating BUP-XR following a single BUP-TM 4 mg dose. Methods: Eligible participants abstained from short and long-acting opioids for 6 and 24 hours, respectively. If the Clinical Opiate Withdrawal Scale (COWS) was >= 8, BUP-TM 4 mg was administered. Participants not exhibiting hypersensitivity, precipitated opioid withdrawal (POW), or sedation symptoms within 1 hour received BUP-XR 300 mg (assessed as inpatients for 48 hours and outpatients to Day 29). Endpoints were COWS score increase >= 6, independent adjudication of POW, and opioid use. Results: Twenty-six participants (14 male) received BUP-TM, 24 received BUP-XR, and 20 completed the study. After injection, COWS scores decreased from pre-BUP-TM baseline of 14.6 +/- 4.1 to 6.9 +/- 4.1 at 6 hours and 4.2 +/- 3.2 at 24 hours. Most participants (62.5%) experienced maximum COWS scores pre-BUP-XR; 2 experienced a COWS score increase >= 6, occurring at 1 and 2 hours post-BUP-XR. By adjudication, 2/24 participants experienced POW. Irritability, anxiety, nausea, and pain were the most frequent adverse events (AEs) with no serious AEs. Conclusions: Results support increased flexibility for initiating BUP-XR. Initiating BUP-XR 300 mg following a single BUP-TM 4 mg dose was well tolerated. Although some participants initially experienced withdrawal symptoms after injection, significant symptomatic improvement was observed in all participants within 24 hours.
引用
收藏
页码:43 / 52
页数:10
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