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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
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‐inferiorit...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314106/ https://www.ncbi.nlm.nih.gov/pubmed/35129242 http://dx.doi.org/10.1111/add.15836 |
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author | Korthuis, P. Todd Cook, Ryan R. Lum, Paula J. Waddell, Elizabeth Needham Tookes, Hansel Vergara‐Rodriguez, Pamela Kunkel, Lynn E. Lucas, Gregory M. Rodriguez, Allan E. Bielavitz, Sarann Fanucchi, Laura C. Hoffman, Kim A. Bachrach, Ken Payne, Elizabeth H. Collins, Julia A. Matthews, Abigail Oden, Neal Jacobs, Petra Jelstrom, Eve Sorensen, James L. McCarty, Dennis |
author_facet | Korthuis, P. Todd Cook, Ryan R. Lum, Paula J. Waddell, Elizabeth Needham Tookes, Hansel Vergara‐Rodriguez, Pamela Kunkel, Lynn E. Lucas, Gregory M. Rodriguez, Allan E. Bielavitz, Sarann Fanucchi, Laura C. Hoffman, Kim A. Bachrach, Ken Payne, Elizabeth H. Collins, Julia A. Matthews, Abigail Oden, Neal Jacobs, Petra Jelstrom, Eve Sorensen, James L. McCarty, Dennis |
author_sort | Korthuis, P. Todd |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9314106 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93141062022-07-30 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 Korthuis, P. Todd Cook, Ryan R. Lum, Paula J. Waddell, Elizabeth Needham Tookes, Hansel Vergara‐Rodriguez, Pamela Kunkel, Lynn E. Lucas, Gregory M. Rodriguez, Allan E. Bielavitz, Sarann Fanucchi, Laura C. Hoffman, Kim A. Bachrach, Ken Payne, Elizabeth H. Collins, Julia A. Matthews, Abigail Oden, Neal Jacobs, Petra Jelstrom, Eve Sorensen, James L. McCarty, Dennis Addiction Research Reports 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. John Wiley and Sons Inc. 2022-03-02 2022-07 /pmc/articles/PMC9314106/ /pubmed/35129242 http://dx.doi.org/10.1111/add.15836 Text en © 2022 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Research Reports Korthuis, P. Todd Cook, Ryan R. Lum, Paula J. Waddell, Elizabeth Needham Tookes, Hansel Vergara‐Rodriguez, Pamela Kunkel, Lynn E. Lucas, Gregory M. Rodriguez, Allan E. Bielavitz, Sarann Fanucchi, Laura C. Hoffman, Kim A. Bachrach, Ken Payne, Elizabeth H. Collins, Julia A. Matthews, Abigail Oden, Neal Jacobs, Petra Jelstrom, Eve Sorensen, James L. McCarty, Dennis 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314106/ https://www.ncbi.nlm.nih.gov/pubmed/35129242 http://dx.doi.org/10.1111/add.15836 |
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