PMID- 36001871
OWN - NLM
STAT- MEDLINE
DCOM- 20230227
LR  - 20230303
IS  - 1097-9891 (Electronic)
IS  - 0095-2990 (Linking)
VI  - 49
IP  - 1
DP  - 2023 Jan 2
TI  - Open-label, rapid initiation pilot study for extended-release buprenorphine 
      subcutaneous injection.
PG  - 43-52
LID - 10.1080/00952990.2022.2106574 [doi]
AB  - 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.
FAU - Hassman, Howard
AU  - Hassman H
AD  - Hassman Research Institute, Marlton, NJ, USA.
FAU - Strafford, Stephanie
AU  - Strafford S
AD  - Indivior Inc, Richmond, VA, USA.
FAU - Shinde, Sunita N
AU  - Shinde SN
AD  - Indivior Inc, Richmond, VA, USA.
FAU - Heath, Amy
AU  - Heath A
AD  - Indivior Inc, Richmond, VA, USA.
FAU - Boyett, Brent
AU  - Boyett B
AD  - Bradford Health Services, Birmingham, AL, USA.
FAU - Dobbins, Robert L
AU  - Dobbins RL
AD  - Indivior Inc, Richmond, VA, USA.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220824
PL  - England
TA  - Am J Drug Alcohol Abuse
JT  - The American journal of drug and alcohol abuse
JID - 7502510
RN  - 0 (Analgesics, Opioid)
RN  - 40D3SCR4GZ (Buprenorphine)
RN  - 0 (Delayed-Action Preparations)
RN  - 5S6W795CQM (Naltrexone)
RN  - 0 (Narcotic Antagonists)
SB  - IM
MH  - Humans
MH  - Male
MH  - Analgesics, Opioid/therapeutic use
MH  - *Buprenorphine/therapeutic use
MH  - Delayed-Action Preparations/therapeutic use
MH  - Injections, Subcutaneous
MH  - Naltrexone/therapeutic use
MH  - Narcotic Antagonists/therapeutic use
MH  - *Opioid-Related Disorders/drug therapy
MH  - Pilot Projects
MH  - *Substance Withdrawal Syndrome/drug therapy
OTO - NOTNLM
OT  - Addiction
OT  - craving
OT  - opioid use disorder
OT  - withdrawal
EDAT- 2022/08/25 06:00
MHDA- 2023/02/25 06:00
CRDT- 2022/08/24 16:22
PHST- 2022/08/25 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2022/08/24 16:22 [entrez]
AID - 10.1080/00952990.2022.2106574 [doi]
PST - ppublish
SO  - Am J Drug Alcohol Abuse. 2023 Jan 2;49(1):43-52. doi: 
      10.1080/00952990.2022.2106574. Epub 2022 Aug 24.