Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial

Bisaga, Adam; Mannelli, Paolo; Yu, Miao; Nangia, Narinder; Graham, Christine; Tompkins, D. Andrew; Kosten, Thomas R.; Akerman, Sarah C.; Silverman, Bernard L.; Sullivan, Maria A.

doi:10.1016/j.drugalcdep.2018.02.023

Cited by 39 publications

(34 citation statements)

References 30 publications

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“…[52][53][54][55] A major barrier to successful treatment of opioid use disorder with extended-release naltrexone is induction failure, as patients are often unable to abstain from opioids for the requisite 7-10 days. 8,9,56 A principal reason for opioid use during this period is the emergence of withdrawal symptoms, particularly in outpatient settings. Improving induction success rates, particularly in relation to the management of withdrawal before extended-release naltrexone administration, remains an active area of investigation.…”

Section: Managing Withdrawal In the Context Of Moud Treatment Initiationmentioning

confidence: 99%

“…An outpatient randomised controlled trial in patients with opioid use disorder (n=378) was done by Bisaga and colleagues 56 to evaluate a naltrexone-buprenorphine protocol, consisting of concurrent naltrexone up-titration and buprenorphine tapering over a 7-day period with subsequent administration of extended-release naltrexone. The comparison groups were given either naltrexone and buprenorphine, naltrexone and buprenorphine placebo, or buprenorphine placebo and naltrexone placebo.…”

Section: Managing Withdrawal In the Context Of Moud Treatment Initiationmentioning

confidence: 99%

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New directions in the treatment of opioid withdrawal

2020

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The treatment of opioid withdrawal is an important area of clinical concern when treating patients with chronic, non-cancer pain, patients with active opioid use disorder, and patients receiving medication for opioid use disorder. Current standards of care for medically supervised withdrawal include treatment with μ-opioid receptor agonists, (eg, methadone), partial agonists (eg, buprenorphine), and α2-adrenergic receptor agonists (eg, clonidine and lofexidine). Newer agents likewise exploit these pharmacological mechanisms, including tramadol (μ-opioid receptor agonism) and tizanidine (α2 agonism). Areas for future research include managing withdrawal in the context of stabilising patients with opioid use disorder to extended-release naltrexone, transitioning patients with opioid use disorder from methadone to buprenorphine, and tapering opioids in patients with chronic, non-cancer pain.

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Section: Managing Withdrawal In the Context Of Moud Treatment Initiationmentioning

confidence: 99%

Section: Managing Withdrawal In the Context Of Moud Treatment Initiationmentioning

confidence: 99%

New directions in the treatment of opioid withdrawal

2020

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“…Early withdrawal responses indicative of completion were previously observed in other opioid detoxification trials of comparable length and using similar medications, including buprenorphine taper, alpha‐2‐adrenergic receptor agonists, and symptomatic ancillary drugs . The use of very low doses of naltrexone has been associated with reduced withdrawal expression in combination with clonidine during methadone detoxification, and upon buprenorphine discontinuation and XR‐NTX administration in OUD patients . However, no improvement in completion rates has been recorded.…”

Section: Discussionmentioning

confidence: 83%

“…Descriptive statistics (mean and SD, number, percent, and percent changes from baseline) were calculated for demographic and clinical features and efficacy measures. Successful induction was defined as no more than mild discomfort (COWS ≤12) recorded 1 hour and 1 day post‐injection, as reported by other investigations of XR‐NTX induction …”

Section: Methodsmentioning

confidence: 99%

Withdrawal severity and early response to treatment in the outpatient transition from opioid use to extended release naltrexone

Mannelli

Swartz

Wu³

2018

American J Addict

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“…Of additional clinical import, there is a growing group of persons interested in transitioning from buprenorphine to extended-release naltrexone 23 , the newest maintenance treatment for OUD. The transition to an opioid-free state is difficult and may limit the efficacy of naltrexone 24 .…”

Section: Introductionmentioning

confidence: 99%

Worries About Discontinuing Buprenorphine Treatment: Scale Development and Clinical Correlates

et al. 2019

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Background and Objectives: Despite the benefits of maintenance buprenorphine treatment for opioid use disorder (OUD), many individuals report an interest in discontinuing the medication, while also expressing worries about tapering. The purpose of this study was to develop a measure of worries about buprenorphine discontinuation ("Off Bupe") and determine the demographic and clinical characteristics associated with these worries. Methods: Between May 2017 and May 2018, we surveyed adults in an outpatient primary care buprenorphine program (n=138). Reliability and validity of the Off Bupe measure were examined. Results: Participants averaged 39 years of age, 54% were male, average duration of buprenorphine was 189 weeks and 85.5% reported eventually wanting to discontinue buprenorphine, although fewer than 10% were actively tapering. We derived two scales, withdrawal symptom worry (10 items, alpha= .94) and relapse worry (7 items, alpha= .88). Worry about symptoms was positively associated with current buprenorphine dose (p = .016), physical discomfort avoidance (p < .001), and inversely associated with self-efficacy to quit buprenorphine (p < .001) and distress tolerance (p < .001). Worry about opioid relapse was associated positively with age (p = .019), current buprenorphine dose (p = .004), physical discomfort avoidance (p <. 001) and impulsivity (p = .002), and inversely associated with self-efficacy to quit buprenorphine (p < .001). Discussion and Conclusions: Psychometric evaluation of the "Off Bupe" scale demonstrated its content and construct validity, and internal reliability. Scientific Significance: The scale might help individuals with OUD and their providers identify concerns about discontinuing buprenorphine.

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Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial

Cited by 39 publications

References 30 publications

New directions in the treatment of opioid withdrawal

New directions in the treatment of opioid withdrawal

Withdrawal severity and early response to treatment in the outpatient transition from opioid use to extended release naltrexone

Worries About Discontinuing Buprenorphine Treatment: Scale Development and Clinical Correlates

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