Baseline- and treatment-associated pain in the X:BOT comparative effectiveness study of extended-release naltrexone versus buprenorphine-naloxone for OUD.
buprenorphine-naloxone
injectable extended-release naltrexone
pain
Journal
Addiction biology
ISSN: 1369-1600
Titre abrégé: Addict Biol
Pays: United States
ID NLM: 9604935
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
revised:
06
10
2021
received:
16
04
2021
accepted:
20
10
2021
pubmed:
9
12
2021
medline:
4
3
2022
entrez:
8
12
2021
Statut:
ppublish
Résumé
Chronic pain is highly prevalent among patients with opioid use disorder (OUD). However, little is known about how pharmacological treatments for OUD, for example, extended-release naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX), affect pain. To begin addressing this question, we performed a secondary analysis of pain data on a large prospective 24-week, open-label, randomized-controlled comparative effectiveness trial of XR-NTX versus BUP-NX (X:BOT trial). Participants' pain status was measured by the EuroQol (EQ-5D). Based on their responses to the pain question at baseline, participants were dichotomized into "Pain" versus "No Pain" categories. Participant's pain status was evaluated every 4 weeks. A mixed effects longitudinal logistic regression model was fitted to examine the differential effect of XR-NTX versus BUP-NX on pain, modelling pain at all available follow-up assessments, adjusted for age, sex, and baseline pain. A total of 474 individuals who were successfully inducted onto their assigned medications were included in this analysis. Among participants endorsing pain at baseline, substantial reductions in pain were observed over the course of the study in both treatment groups. Howecver reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07-2.40], P = 0.023). Future research using instruments and design specifically focused on pain could extend the present observations and evaluate their clinical significance.
Substances chimiques
Buprenorphine, Naloxone Drug Combination
0
Delayed-Action Preparations
0
Narcotic Antagonists
0
Naltrexone
5S6W795CQM
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13112Subventions
Organisme : NICHD NIH HHS
ID : R00 HD084746
Pays : United States
Informations de copyright
© 2021 Society for the Study of Addiction.
Références
Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003;289(18):2370-2378.
Eyler EC. Chronic and acute pain and pain management for patients in methadone maintenance treatment. Am J Addict. 2013;22(1):75-83.
Shulman M, Luo S, Campbell ANC, et al. Secondary Analysis of Pain Outcomes in a Large Pragmatic Randomized Trial of Buprenorphine/Naloxone Versus Methadone for Opioid Use Disorder. J Addict Med. 2020;14(5):e188-e194.
Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016;315(15):1624-1645.
Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156(4):569-576.
Salsitz EA. Chronic Pain, Chronic Opioid Addiction: a Complex Nexus. J Med Toxicol. 2016;12(1):54-57.
Speed TJ, Parekh V, Coe W, Antoine D. Comorbid chronic pain and opioid use disorder: literature review and potential treatment innovations. Int Rev Psychiatry. 2018;30(5):136-146.
Drug Enforcement Administration DoJ. Schedules of Controlled Substances: Rescheduling of Buprenorphine From Schedule V to Schedule III2002 [Available from: https://www.deadiversion.usdoj.gov/fed_regs/rules/2002/fr1007.htm].
Substance Abuse and Mental Health Service Administration. Buprenorphine is used in medication-assisted treatment (MAT) to treat Opioid Use Disorder (OUD). 2020.
Aiyer R, Gulati A, Gungor S, Bhatia A, Mehta N. Treatment of Chronic Pain With Various Buprenorphine Formulations: A Systematic Review of Clinical Studies. Anesth Analg. 2018;127(2):529-538.
Webster L, Gudin J, Raffa RB, et al. Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. Pain Med. 2020;21(4):714-723.
Chang HM, Chen LY. Management of chronic pain and opioid dependence with buprenorphine/naloxone. Psychiatry Clin Neurosci. 2018;72(6):454.
Streltzer J, Davidson R, Goebert D. An observational study of buprenorphine treatment of the prescription opioid dependent pain patient. Am J Addict. 2015;24(4):357-361.
Neumann AM, Blondell RD, Jaanimagi U, et al. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78.
Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011;377(9776):1506-1513.
Latif ZE, Solli KK, Opheim A, et al. No increased pain among opioid-dependent individuals treated with extended-release naltrexone or buprenorphine-naloxone: A 3-month randomized study and 9-month open-treatment follow-up study. Am J Addict. 2019;28(2):77-85.
Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013;65(2):529-538.
Smith JP, Bingaman SI, Ruggiero F, et al. Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn's disease: a randomized placebo-controlled trial. Dig Dis Sci. 2011;56(7):2088-2097.
Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, Majdinasab N, Shalbafan B. The effect of low-dose naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-controlled trial. Mult Scler. 2010;16(8):964-969.
Miller JL, Hagemann TM. Use of pure opioid antagonists for management of opioid-induced pruritus. Am J Health Syst Pharm. 2011;68(15):1419-1425.
Ghai B, Bansal D, Hota D, Shah CS. Off-label, low-dose naltrexone for refractory chronic low back pain. Pain Med. 2014;15(5):883-884.
Malekzad F, Arbabi M, Mohtasham N, et al. Efficacy of oral naltrexone on pruritus in atopic eczema: a double-blind, placebo-controlled study. J Eur Acad Dermatol Venereol. 2009;23(8):948-950.
Metze D, Reimann S, Beissert S, Luger T. Efficacy and safety of naltrexone, an oral opiate receptor antagonist, in the treatment of pruritus in internal and dermatological diseases. J Am Acad Dermatol. 1999;41(4):533-539.
Lee JD, Nunes EV Jr, Novo P, et al. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018;391(10118):309-318.
Lee JD, Nunes EV, Mpa PN, et al. NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale. Contemp Clin Trials. 2016;50:253-264.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337-343.
Spronk I, Bonsel GJ, Polinder S, van Baar ME, Janssen MF, Haagsma JA. Exploring the relation between the EQ-5D-5L pain/discomfort and pain and itching in a sample of burn patients. Health Qual Life Outcomes. 2020;18(1):144.
Durham J, Steele JG, Breckons M, Story W, Vale L. DEEP Study: does EQ-5D-5L measure the impacts of persistent oro-facial pain? J Oral Rehabil. 2015;42(9):643-650.
Soer R, Reneman MF, Speijer BL, Coppes MH, Vroomen PC. Clinimetric properties of the EuroQol-5D in patients with chronic low back pain. Spine J. 2012;12(11):1035-1039.
Cheung PWH, Wong CKH, Cheung JPY. Differential Psychometric Properties of EuroQoL 5-Dimension 5-Level and Short-Form 6-Dimension Utility Measures in Low Back Pain. Spine (Phila Pa 1976). 2019;44(11):E679-E686.
Brush DE. Complications of long-term opioid therapy for management of chronic pain: the paradox of opioid-induced hyperalgesia. J Med Toxicol. 2012;8(4):387-392.
Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006;104(3):570-587.
Ramasubbu C, Gupta A. Pharmacological treatment of opioid-induced hyperalgesia: a review of the evidence. J Pain Palliat Care Pharmacother. 2011;25(3):219-230.
Raffa RB, Pergolizzi JV Jr. Multi-mechanistic analgesia for opioid-induced hyperalgesia. J Clin Pharm Ther. 2012;37(2):125-127.
Compton P, Ling W, Charuvastra VC. Hyperalgesia in methadone-maintained patients. In: Harris LS, ed. Problems of Drug Dependence: National Institute on Drug Abuse. 1998:228.
Aguado D, Abreu M, Benito J, Garcia-Fernandez J, Gomez de Segura IA. Effects of naloxone on opioid-induced hyperalgesia and tolerance to remifentanil under sevoflurane anesthesia in rats. Anesthesiology. 2013;118(5):1160-1169.
Liu B, Du L, Hong JS. Naloxone protects rat dopaminergic neurons against inflammatory damage through inhibition of microglia activation and superoxide generation. J Pharmacol Exp Ther. 2000;293(2):607-617.
Watkins LR, Hutchinson MR, Ledeboer A, Wieseler-Frank J, Milligan ED, Maier SF. Norman Cousins Lecture. Glia as the "bad guys": implications for improving clinical pain control and the clinical utility of opioids. Brain Behav Immun. 2007;21(2):131-146.
Tempel A, Gardner EL, Zukin RS. Neurochemical and functional correlates of naltrexone-induced opiate receptor up-regulation. J Pharmacol Exp Ther. 1985;232(2):439-444.
Narita M, Mizoguchi H, Nagase H, Suzuki T, Tseng LF. Up-regulation of spinal mu-opioid receptor function to activate G-protein by chronic naloxone treatment. Brain Res. 2001;913(2):170-173.
Rajashekara V, Patel CN, Patel K, Purohit V, Yoburn BC. Chronic opioid antagonist treatment dose-dependently regulates mu-opioid receptors and trafficking proteins in vivo. Pharmacol Biochem Behav. 2003;75(4):909-913.
Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72(3):333-337.
Wang A-L, Elman I, Lowen SB, et al. Neural correlates of adherence to extended-release naltrexone pharmacotherapy in heroin dependence. Translational Psychiatry. 2015;5(3):e531-e531. https://doi.org/10.1038/tp.2015.20
Kolaric S, Makulska-Nowak HE, Gumulka SW, Mizerska K. Paradoxical effects of intracerebroventricular low-dose opioid antagonists in SHR with chronic pain. Life Sci. 1999;65(4):395-402.
Nunes EV, Scodes JM, Pavlicova M, et al. Moderators of Sublingual Buprenorphine versus Injection Naltrexone for Treatment of Opioid Use Disorder: Can Patient Characteristics Guide Choice of Treatment? Submitting. 2020;178(7):660-671.
Patel KV, Allen R, Burke L, et al. Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials: an ACTTION individual patient data analysis. Pain. 2018;159(11):2245-2254.
Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33(4):451-459.
Ekelem C, Juhasz M, Khera P, Mesinkovska NA. Utility of Naltrexone Treatment for Chronic Inflammatory Dermatologic Conditions: A Systematic Review. JAMA Dermatol. 2019;155(2):229-236.
Davis MP, Pasternak G, Behm B. Treating Chronic Pain: An Overview of Clinical Studies Centered on the Buprenorphine Option. Drugs. 2018;78(12):1211-1228.
Krawczyk N, Mojtabai R, Stuart EA, et al. Opioid agonist treatment and fatal overdose risk in a state-wide US population receiving opioid use disorder services. Addiction. 2020;115(9):1683-1694.
Ma J, Bao YP, Wang RJ, et al. Effects of medication-assisted treatment on mortality among opioids users: a systematic review and meta-analysis. Mol Psychiatry. 2019;24(12):1868-1883.
Blevins CE, Abrantes AM, Kurth ME, Gordon AL, Stein MD. Quality of life and well-being following inpatient and partial hospitalization treatment for opioid use disorder. Arch Psychiatr Nurs. 2018;32(3):505-509.