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. |
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| 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] |
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| Database: | Psychology and Behavioral Sciences Collection |
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| 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] |
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| ISSN: | 09652140 |
| DOI: | 10.1111/add.14735 |
