HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.
Buprenorphine
HIV
extended-release naltrexone
methadone
non-inferiority trial
opioid-related disorders
randomized controlled trials
Journal
Addiction (Abingdon, England)
ISSN: 1360-0443
Titre abrégé: Addiction
Pays: England
ID NLM: 9304118
Informations de publication
Date de publication:
07 2022
07 2022
Historique:
received:
28
05
2021
accepted:
13
01
2022
pubmed:
8
2
2022
medline:
18
6
2022
entrez:
7
2
2022
Statut:
ppublish
Résumé
Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results. Open-label, non-inferiority randomized trial. Six US HIV primary care clinics. A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks. Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2). A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.
Sections du résumé
BACKGROUND AND AIM
Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.
DESIGN
Open-label, non-inferiority randomized trial.
SETTING
Six US HIV primary care clinics.
PARTICIPANTS
A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment.
INTERVENTION
HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59).
MEASUREMENTS
Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks.
FINDINGS
Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2).
CONCLUSIONS
A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.
Identifiants
pubmed: 35129242
doi: 10.1111/add.15836
pmc: PMC9314106
doi:
Substances chimiques
Analgesics, Opioid
0
Delayed-Action Preparations
0
Narcotic Antagonists
0
Naltrexone
5S6W795CQM
Types de publication
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1961-1971Subventions
Organisme : NIDA NIH HHS
ID : K24 DA035684
Pays : United States
Organisme : NIDA NIH HHS
ID : UG1 DA015815
Pays : United States
Organisme : AHRQ HHS
ID : K12 HS026370
Pays : United States
Organisme : NIDA NIH HHS
ID : UG1 DA013732
Pays : United States
Informations de copyright
© 2022 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.
Références
Drug Alcohol Depend. 2018 Nov 1;192:186-192
pubmed: 30266003
Am J Drug Alcohol Abuse. 2018;44(3):302-309
pubmed: 28795846
Drug Alcohol Depend. 2014 Jun 1;139:79-85
pubmed: 24726429
N Engl J Med. 2006 Jul 27;355(4):365-74
pubmed: 16870915
JAMA. 2012 Jul 25;308(4):387-402
pubmed: 22820792
BMJ. 2017 Apr 26;357:j1550
pubmed: 28446428
Ann Intern Med. 2010 Jun 1;152(11):704-11
pubmed: 20513828
J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S22-32
pubmed: 21317590
Clin Infect Dis. 2016 Oct 15;63(8):1094-1104
pubmed: 27343545
BMC Med Res Methodol. 2019 Mar 29;19(1):71
pubmed: 30925900
J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S33-8
pubmed: 21317592
Eur Addict Res. 2019;25(6):303-309
pubmed: 31340204
PLoS One. 2015 Jun 19;10(6):e0130090
pubmed: 26090989
JAMA Psychiatry. 2017 Dec 1;74(12):1197-1205
pubmed: 29049469
J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S83-90
pubmed: 21317600
Lancet. 2018 Jan 27;391(10118):309-318
pubmed: 29150198
N Engl J Med. 2016 Mar 31;374(13):1232-42
pubmed: 27028913
J Acquir Immune Defic Syndr. 2013 Feb 1;62(2):149-63
pubmed: 23187941
J Acquir Immune Defic Syndr. 2018 May 1;78(1):43-53
pubmed: 29373393
Addiction. 2022 Jul;117(7):1961-1971
pubmed: 35129242
Addiction. 2008 Nov;103(11):1828-36
pubmed: 18778390
Addiction. 2018 Jul;113(7):1188-1209
pubmed: 29396985
Addiction. 2017 Jun;112(6):1036-1044
pubmed: 28061017
BMC Health Serv Res. 2019 Nov 21;19(1):862
pubmed: 31752905
Drug Alcohol Depend. 2018 Jun 1;187:171-178
pubmed: 29674251
J Subst Abuse Treat. 2012 Dec;43(4):458-62
pubmed: 22985676
Lancet HIV. 2019 Apr;6(4):e221-e229
pubmed: 30880163
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Am J Drug Alcohol Abuse. 2012 May;38(3):187-99
pubmed: 22404717
AIDS Res Hum Retroviruses. 1994;10 Suppl 2:S281-3
pubmed: 7865319