Fatal and non-fatal opioid overdose in opioid dependent patients treated with methadone, buprenorphine or implant naltrexone

Kelty, Erin; Hulse, Gary Kenneth

doi:10.1016/j.drugpo.2017.05.039

Cited by 63 publications

(40 citation statements)

References 32 publications

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“…12–15 Important clinical issues remain unanswered, beyond the established efficacy of either XR-NTX or BUP-NX. How feasible is XR-NTX induction compared with buprenorphine-naloxone (BUP-NX) among active opioid users admitted voluntarily to real-world, community detoxification centres?…”

Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial

et al. 2018

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Summary Background Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. Methods We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients. Participants were 18 years or older, had Diagnostic and Statistical Manual of Mental Disorders-5 opioid use disorder, and had used non-prescribed opioids in the past 30 days. We stratified participants by treatment site and opioid use severity and used a web-based permuted block design with random equally weighted block sizes of four and six for randomisation (1:1) to receive XR-NTX or BUP-NX. XR-NTX was monthly intramuscular injections (Vivitrol; Alkermes) and BUP-NX was daily self-administered buprenorphine-naloxone sublingual film (Suboxone; Indivior). The primary outcome was opioid relapse-free survival during 24 weeks of outpatient treatment. Relapse was 4 consecutive weeks of any non-study opioid use by urine toxicology or self-report, or 7 consecutive days of self-reported use. This trial is registered with ClinicalTrials.gov, NCT02032433. Findings Between Jan 30, 2014, and May 25, 2016, we randomly assigned 570 participants to receive XR-NTX (n=283) or BUP-NX (n=287). The last follow-up visit was Jan 31, 2017. As expected, XR-NTX had a substantial induction hurdle: fewer participants successfully initiated XR-NTX (204 [72%] of 283) than BUP-NX (270 [94%] of 287; p<0·0001). Among all participants who were randomly assigned (intention-to-treat population, n=570) 24 week relapse events were greater for XR-NTX (185 [65%] of 283) than for BUP-NX (163 [57%] of 287; hazard ratio [HR] 1·36, 95% CI 1·10–1·68), most or all of this difference accounted for by early relapse in nearly all (70 [89%] of 79) XR-NTX induction failures. Among participants successfully inducted (per-protocol population, n=474), 24 week relapse events were similar across study groups (p=0·44). Opioid-negative urine samples (p<0·0001) and opioid-abstinent days (p<0·0001) favoured BUP-NX compared with XR-NTX among the intention-to-treat population, but were similar across study groups among the per-protocol population. Self-reported opioid craving was initially less with XR-NTX than with BUP-NX (p=0·0012), then converged by week 24 (p=0·20). With the exception of mild-to-moderate XR-NTX injection site reactions, treatment-emergent adverse events including overdose did not differ between treatment groups. Five fatal overdoses occurred (two in the XR-NTX group and three in the BUP-NX group). Interpretation In this population it is more difficult to initiate patients to XR-NTX than BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective. Future wo...

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Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial

et al. 2018

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“…Studies of sustained‐release formulations of naltrexone have been criticized for the lack of post‐treatment reporting of adverse events, including overdoses . A recent study found no significant differences in rates of overdoses among people with opioid dependence treated with opioid agonist treatment or naltrexone implants, including after treatment cessation .…”

Section: Introductionmentioning

confidence: 99%

Effectiveness, safety and feasibility of extended‐release naltrexone for opioid dependence: a 9‐month follow‐up to a 3‐month randomized trial

et al. 2018

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“…In addition, for those who can be maintained on buprenorphine 8 mg daily, a 6-month implant of four rods, each containing 80 mg of buprenorphine, is available (FDA, 2016). The partial mu agonist effect decreases the risk of respiratory depression unless there is concomitant use of other central nervous system depressants (Kelty & Hulse, 2017;SAMHSA, 2016). Buprenorphine may be a safer option than methadone owing to its ceiling effect (Sordo et al, 2017), decreased risk of QTc prolongation, and fewer clinically significant drug interactions (McCance-Katz, Sullivan, & Nallani, 2010).…”

Section: Buprenorphinementioning

confidence: 99%

Managing Pain in the Setting of Opioid Use Disorder

Marie

Broglio

2020

Pain Management Nursing

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Specific Clinical Issue: Healthcare providers are challenged with managing pain and minimizing morbidity and mortality associated with opioid use disorder. Major Practice Recommendations Based on Best Evidence: The purpose of this article is to guide acute and ambulatory care clinicians in managing pain in patients with opioid use disorder. Included in this article is a review of medications used for opioid use disorder, a discussion of the management of patients with active opioid use disorder and acute or chronic pain, and a discussion of the management of acute and chronic pain in people in recovery both on and off medications for opioid use disorder.

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Fatal and non-fatal opioid overdose in opioid dependent patients treated with methadone, buprenorphine or implant naltrexone

Cited by 63 publications

References 32 publications

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial

Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial

Effectiveness, safety and feasibility of extended‐release naltrexone for opioid dependence: a 9‐month follow‐up to a 3‐month randomized trial

Managing Pain in the Setting of Opioid Use Disorder

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