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Opioid use and dropout from extended‐release naltrexone in a controlled trial: implications for mechanism.

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Title: Opioid use and dropout from extended‐release naltrexone in a controlled trial: implications for mechanism.
Authors: Nunes, Edward V. (AUTHOR), Bisaga, Adam (AUTHOR), Krupitsky, Evgeny (AUTHOR), Nangia, Narinder (AUTHOR), Silverman, Bernard L. (AUTHOR), Akerman, Sarah C. (AUTHOR), Sullivan, Maria A. (AUTHOR)
Source: Addiction. Feb2020, Vol. 115 Issue 2, p239-246. 8p. 2 Charts, 1 Graph.
Subjects: Opioid abuse, Controlled release preparations, Drug abuse treatment, Patient dropouts, Naltrexone
Abstract: Background and aims: Extended‐release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post‐hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo‐controlled trial of extended‐release injection naltrexone (XR‐NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness. Design This was a 24‐week multiple‐site, double‐blind, randomized trial of monthly XR‐NTX versus placebo injections. We analyzed time to dropout from treatment using survival analysis with an extended Cox model as a function of treatment (XR‐NTX versus placebo) and with weekly urine drug test (UDT) results for opioids at each week as a time‐dependent covariate. Setting: Thirteen addiction treatment programs in Russia, 2008–09. Participants: A total of 250 adults with opioid use disorder who had completed in‐patient detoxification. Intervention: XR‐NTX injection or placebo injection every 4 weeks with weekly clinic visits and biweekly counseling. Measurements Urine toxicology for opioids measured weekly and week of dropout from treatment. Findings The Cox model yielded a significant interaction of time‐dependent urine toxicology by treatment (P = 0.024). Among patients receiving placebo, a positive UDT in a given week increased the risk for dropout from treatment in the subsequent week [hazard ratio (HR) = 6.25; 95% confidence interval (CI) = 3.6–10.0], whereas among patients receiving XR‐NTX, a positive UDT result showed no significant effect on risk for dropout (HR = 1.67; 95% CI = 0.6–4.5). The proportion of patients who completed all 24 weeks without any positive UDT result was 31% on XR‐NTX compared with 20% on placebo (P = 0.051). Conclusions: Extended‐release injection naltrexone was effective at reducing the risk of dropout from opioid use disorder treatment after an episode of opioid use. Just under a third of patients (31%) on XR‐NTX had no opioid‐positive urine tests across the trial, but the hypothesis that this would differ from placebo (20%) was not confirmed. [ABSTRACT FROM AUTHOR]
Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Opioid use and dropout from extended‐release naltrexone in a controlled trial: implications for mechanism.
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  Data: <searchLink fieldCode="AR" term="%22Nunes%2C+Edward+V%2E%22">Nunes, Edward V.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bisaga%2C+Adam%22">Bisaga, Adam</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Krupitsky%2C+Evgeny%22">Krupitsky, Evgeny</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nangia%2C+Narinder%22">Nangia, Narinder</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Silverman%2C+Bernard+L%2E%22">Silverman, Bernard L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Akerman%2C+Sarah+C%2E%22">Akerman, Sarah C.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sullivan%2C+Maria+A%2E%22">Sullivan, Maria A.</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Addiction%22">Addiction</searchLink>. Feb2020, Vol. 115 Issue 2, p239-246. 8p. 2 Charts, 1 Graph.
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  Data: <searchLink fieldCode="DE" term="%22Opioid+abuse%22">Opioid abuse</searchLink><br /><searchLink fieldCode="DE" term="%22Controlled+release+preparations%22">Controlled release preparations</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+abuse+treatment%22">Drug abuse treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+dropouts%22">Patient dropouts</searchLink><br /><searchLink fieldCode="DE" term="%22Naltrexone%22">Naltrexone</searchLink>
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  Data: Background and aims: Extended‐release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post‐hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo‐controlled trial of extended‐release injection naltrexone (XR‐NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness. Design This was a 24‐week multiple‐site, double‐blind, randomized trial of monthly XR‐NTX versus placebo injections. We analyzed time to dropout from treatment using survival analysis with an extended Cox model as a function of treatment (XR‐NTX versus placebo) and with weekly urine drug test (UDT) results for opioids at each week as a time‐dependent covariate. Setting: Thirteen addiction treatment programs in Russia, 2008–09. Participants: A total of 250 adults with opioid use disorder who had completed in‐patient detoxification. Intervention: XR‐NTX injection or placebo injection every 4 weeks with weekly clinic visits and biweekly counseling. Measurements Urine toxicology for opioids measured weekly and week of dropout from treatment. Findings The Cox model yielded a significant interaction of time‐dependent urine toxicology by treatment (P = 0.024). Among patients receiving placebo, a positive UDT in a given week increased the risk for dropout from treatment in the subsequent week [hazard ratio (HR) = 6.25; 95% confidence interval (CI) = 3.6–10.0], whereas among patients receiving XR‐NTX, a positive UDT result showed no significant effect on risk for dropout (HR = 1.67; 95% CI = 0.6–4.5). The proportion of patients who completed all 24 weeks without any positive UDT result was 31% on XR‐NTX compared with 20% on placebo (P = 0.051). Conclusions: Extended‐release injection naltrexone was effective at reducing the risk of dropout from opioid use disorder treatment after an episode of opioid use. Just under a third of patients (31%) on XR‐NTX had no opioid‐positive urine tests across the trial, but the hypothesis that this would differ from placebo (20%) was not confirmed. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1111/add.14735
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        Text: English
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        PageCount: 8
        StartPage: 239
    Subjects:
      – SubjectFull: Opioid abuse
        Type: general
      – SubjectFull: Controlled release preparations
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      – SubjectFull: Drug abuse treatment
        Type: general
      – SubjectFull: Patient dropouts
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      – SubjectFull: Naltrexone
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      – TitleFull: Opioid use and dropout from extended‐release naltrexone in a controlled trial: implications for mechanism.
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              Text: Feb2020
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              Y: 2020
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