Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-21 DOI:10.1016/j.cct.2025.107861

Kristin Klemmetsby Solli , Jūratė Šaltytė Benth , Linn Camilla Wergeland Digranes , Line Holtan , Nikolaj Kunoe , Lars Tanum

{"title":"Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals","authors":"Kristin Klemmetsby Solli , Jūratė Šaltytė Benth , Linn Camilla Wergeland Digranes , Line Holtan , Nikolaj Kunoe , Lars Tanum","doi":"10.1016/j.cct.2025.107861","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.</div></div><div><h3>Objectives</h3><div>This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids. Methods: After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.</div></div><div><h3>Results</h3><div>The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (<em>p</em> < 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (<em>p</em> < 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p < 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (<em>n</em> = 35) during the study.</div></div><div><h3>Conclusion</h3><div>Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> no. <span><span>NCT01717963</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107861"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000552","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Mental health status may be improved in patients receiving treatment with the opioid antagonist extended-release naltrexone (XR-NTX), but longer-term outcomes remain unexamined.

Objectives

This study aims to assess changes in symptoms of anxiety, depression, and insomnia among opioid-dependent individuals in long-term treatment with XR-NTX and to explore possible associations between such symptoms and the use of illicit opioids. Methods: After completing an initial 3-month randomized clinical trial and an extended 9-month follow-up study, 50 opioid-dependent individuals (9 women) chose to continue treatment with XR-NTX at their own discretion for a prolonged period of up to 2 years. Symptoms of anxiety, depression, and insomnia were assessed every 4th week. In addition, the participants reported use of illicit opioids.

Results

The participants reported improved mental health status during up to 3 years treatment with XR-NTX. Symptoms of anxiety and depression were reduced from mean 18.0 (SD:6.1) to 12.3 (SD:4.4) (p < 0.001), and from 30.5 (SD:9.1) to 17.8 (SD:5.4) (p < 0.01), respectively, whereas symptoms of insomnia were reduced from 14.2 (SD:7.9) to 3.6 (SD:3.6), (p < 0.001). The reduction in these symptoms was more pronounced in participants who did not relapse to opioid use (n = 35) during the study.

Conclusion

Long-term treatment with XR-NTX may promote a reduction in symptoms of anxiety, depression, and insomnia in opioid-dependent individuals. Those who managed to stay abstinent from opioids were likelier to experience a greater reduction in symptoms compared to those who relapsed to opioid use during the 3-year treatment period.

Clinicaltrials.gov no. NCT01717963

查看原文本刊更多论文

长期使用缓释纳曲酮治疗期间心理健康的变化：阿片类药物依赖个体的3年临床研究

背景：接受阿片类拮抗剂延长释放纳曲酮（XR-NTX）治疗的患者的心理健康状况可能得到改善，但长期结果仍未得到检验。目的：本研究旨在评估长期接受XR-NTX治疗的阿片类药物依赖者焦虑、抑郁和失眠症状的变化，并探讨这些症状与非法阿片类药物使用之间的可能关联。方法：在完成初始3个月的随机临床试验和延长9个月的随访研究后，50名阿片类药物依赖个体（9名女性）根据自己的判断选择继续使用XR-NTX治疗长达2 年。每4周评估一次焦虑、抑郁和失眠的症状。此外，参与者报告了非法阿片类药物的使用情况。结果：在XR-NTX治疗期间，参与者报告了长达3 年的心理健康状况改善。焦虑和抑郁症状从平均18.0 （SD:6.1）减少到12.3 (SD:4.4) （p ）结论：XR-NTX长期治疗可能促进阿片类药物依赖个体焦虑、抑郁和失眠症状的减轻。与那些在3年治疗期间再次使用阿片类药物的人相比，那些设法保持戒断阿片类药物的人更有可能经历更大的症状减轻。临床试验：gov . no。NCT01717963。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.