Miranda G Greiner1, Matisyahu Shulman2, Tse-Hwei Choo3, Jennifer Scodes4, Martina Pavlicova5, Aimee N C Campbell6, Patricia Novo7, Marc Fishman8, Joshua D Lee9, John Rotrosen10, Edward V Nunes11. 1. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: miranda.greiner@nyspi.columbia.edu. 2. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: matisyahu.shulman@nyspi.columbia.edu. 3. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: tse.hwei@nyspi.columbia.edu. 4. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: jennifer.scodes@nyspi.columbia.edu. 5. Columbia University Mailman School of Public Health, 722 West 168th Street, New York, NY 10032, United States of America. Electronic address: mp2370@columbia.edu. 6. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: anc2002@cumc.columbia.edu. 7. New York University Grossman School of Medicine, 550 First Avenue, New York, NY 10016, United States of America. Electronic address: patricia.novo@nyulangone.org. 8. Johns Hopkins University School of Medicine and Maryland Treatment Centers, 3800 Frederick Ave, Baltimore, MD 21229, United States of America. 9. New York University Grossman School of Medicine, 550 First Avenue, New York, NY 10016, United States of America. Electronic address: joshua.lee@nyulangone.org. 10. New York University Grossman School of Medicine, 550 First Avenue, New York, NY 10016, United States of America. Electronic address: john.rotrosen@nyulangone.org. 11. New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address: edward.nunes@nyspi.columbia.edu.
Abstract
AIM: This report examined naturalistic opioid use outcomes and utilization of medications for opioid use disorder (MOUD) 36 weeks post-randomization in the National Drug Abuse Treatment Clinical Trials Network (CTN) Extended-Release Naltrexone (XR-NTX) versus Buprenorphine-Naloxone (BUP-NX) for Opioid Treatment trial (CTN-0051, X:BOT). DESIGN: X:BOT was a multisite, randomized, 24-week comparative effectiveness trial of BUP-NX (N = 287) and XR-NTX (N = 283). Study medications were discontinued following treatment completion, relapse, or dropout. Participants were encouraged to continue MOUD. This report examined opioid use outcomes in 428 (75%) of the 570 participants who attended the 36-week follow-up visit. SETTING AND PARTICIPANTS: Adults with opioid use disorder recruited from 8 community treatment programs across the United States. MEASUREMENTS: Outcomes included medication status (on/off MOUD), type of MOUD (BUP-NX, XR-NTX, or methadone), abstinence from non-prescribed opioids, opioid use days, relapse, and other substance use 30 days prior to the 36-week visit. Relapse was defined as opioid use for 4 consecutive weeks or 7 consecutive days in the past month. Baseline and clinical variables included opioid use severity, intravenous drug use, study medication assignment, and induction status. FINDINGS: Of the 428 participants who completed the 36-week visit, 225 (53%) of participants were receiving MOUD and 203 (47%) were not. Compared to those off medication, participants on medication had fewer opioid use days (4.4 days (SD 9.0) versus 9.8 days (SD 12.1)), fewer met relapse criteria (37 (16.4%) versus 79 (38.9%)), and reported less stimulant use (34 (15.2%) versus 56 (27.7%)) and sedative use (14 (6.3%) versus 31 (15.3%)). There was no difference in abstinence rates between those on or off MOUD. A greater proportion of participants on XR-NTX (47 (53.4%) of 88 participants) were abstinent from non-prescribed opioids compared to those on buprenorphine (28 (23.3%) of 120 participants). CONCLUSIONS: Naturalistic outcomes data showed that despite potential barriers to continuing treatment in the community, about half of individuals were on opioid use disorder pharmacotherapy at follow-up and those on medication generally had better outcomes. Future research should explore barriers and facilitators to treatment retention in community settings; and developing interventions tailored to improve treatment engagement and adherence.
AIM: This report examined naturalistic opioid use outcomes and utilization of medications for opioid use disorder (MOUD) 36 weeks post-randomization in the National Drug Abuse Treatment Clinical Trials Network (CTN) Extended-Release Naltrexone (XR-NTX) versus Buprenorphine-Naloxone (BUP-NX) for Opioid Treatment trial (CTN-0051, X:BOT). DESIGN: X:BOT was a multisite, randomized, 24-week comparative effectiveness trial of BUP-NX (N = 287) and XR-NTX (N = 283). Study medications were discontinued following treatment completion, relapse, or dropout. Participants were encouraged to continue MOUD. This report examined opioid use outcomes in 428 (75%) of the 570 participants who attended the 36-week follow-up visit. SETTING AND PARTICIPANTS: Adults with opioid use disorder recruited from 8 community treatment programs across the United States. MEASUREMENTS: Outcomes included medication status (on/off MOUD), type of MOUD (BUP-NX, XR-NTX, or methadone), abstinence from non-prescribed opioids, opioid use days, relapse, and other substance use 30 days prior to the 36-week visit. Relapse was defined as opioid use for 4 consecutive weeks or 7 consecutive days in the past month. Baseline and clinical variables included opioid use severity, intravenous drug use, study medication assignment, and induction status. FINDINGS: Of the 428 participants who completed the 36-week visit, 225 (53%) of participants were receiving MOUD and 203 (47%) were not. Compared to those off medication, participants on medication had fewer opioid use days (4.4 days (SD 9.0) versus 9.8 days (SD 12.1)), fewer met relapse criteria (37 (16.4%) versus 79 (38.9%)), and reported less stimulant use (34 (15.2%) versus 56 (27.7%)) and sedative use (14 (6.3%) versus 31 (15.3%)). There was no difference in abstinence rates between those on or off MOUD. A greater proportion of participants on XR-NTX (47 (53.4%) of 88 participants) were abstinent from non-prescribed opioids compared to those on buprenorphine (28 (23.3%) of 120 participants). CONCLUSIONS: Naturalistic outcomes data showed that despite potential barriers to continuing treatment in the community, about half of individuals were on opioid use disorder pharmacotherapy at follow-up and those on medication generally had better outcomes. Future research should explore barriers and facilitators to treatment retention in community settings; and developing interventions tailored to improve treatment engagement and adherence.
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