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

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.

Citation

Kristin Klemmetsby Solli, Jūratė Šaltytė Benth, Linn Camilla Wergeland Digranes, Line Holtan, Nikolaj Kunoe, Lars Tanum. Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals. Contemporary Clinical Trials, Volume 152, 2025.

Publisert 4. des. 2025 13:04 - Sist endret 4. des. 2025 13:04