Extended-release naltrexone competes with buprenorphine-naloxone combo

Patients with opioid dependence and anxiety, depression, and insomnia symptoms who receive extended-release naltrexone injections experience similar results to those treated with daily oral buprenorphine-naloxone, research shows. The results suggest that those comorbid symptoms should not prevent a switch from treating patients with an opioid agonist to treating them with extended-release naltrexone, reported Zill-e-Huma Latif, MD, and colleagues.

“Our results showed improvements in anxiety, depression, and insomnia within only a few weeks of beginning either study treatment,” Dr. Latif and colleagues wrote in JAMA Psychiatry. “Our study also showed reductions in the use of opioids and other illegal substances in both treatment groups.”

Dr. Latif and colleagues conducted a prospective, randomized trial of 159 men and women with opioid dependence to receive a 380-mg injectable dose of extended-release naltrexone every 4 weeks or flexible doses (4-24 mg) of daily combined buprenorphine-naloxone for 12 weeks and then a 9-month, open-label period with one of the treatments as chosen by the participant. Of the participants, 105 reached the end of the trial (66%).

The participants were aged 18-60 years and had similar ages, gender distributions, and heroin use duration between treatment groups. The researchers used the 25-item Hopkins Symptom Checklist (HSCL-25) and the Insomnia Severity Index to assess anxiety, depression, and insomnia symptoms every 4 weeks until 48 weeks, reported Dr. Latif, of the department of research and development in mental health at Akershus University Hospital in Norway, and colleagues.

Over 12 weeks of the trial, no differences were found between treatment groups regarding anxiety (effect size, −0.14; 95% confidence interval, −0.47 to 0.19) or depression symptoms scores on the HSCL-25 (ES, −0.12; 95% CI, −0.45 to 0.21). However, the Insomnia Severity Index score was significantly lower among participants taking extended-release naltrexone (ES, −0.32; 95% CI, −0.65 to 0.02; P = .008). In the 9-month, open-label follow-up period, no significant differences were found in anxiety (ES, 0.04; 95% CI, −0.34 to 0.42), depression (ES, −0.04; 95% CI, −0.42 to 0.33), or insomnia (ES, 0.04; 95% CI, −0.33 to 0.42) among participants who switched to extended-release naltrexone or continued using extended-release naltrexone.

“Because participants receiving treatment with [extended-release naltrexone] or [buprenorphine-naloxone] showed equal improvements in anxiety, depression, and insomnia as assessed by the HSCL-25 and the Insomnia Severity Index, such symptoms should not preclude the choice to leave opioid agonist treatment and to start treatment with [extended-release naltrexone],” Dr. Latif and colleagues wrote.

With regard to study limitations, the researchers noted that they used self-reported questionnaires for anxiety, depression, and insomnia symptoms, did not confirm reported drug use through urine samples, and used the HSCL-25 when it is not a diagnostic tool.

The study was funded by grants from the Research Council of Norway and the Western Norway Regional Health Authority; financial support was provided by the Norwegian Center for Addiction Research, University of Oslo, and Akershus University Hospital. The authors report no relevant conflicts of interest.

SOURCE: Latif Z-H et al. JAMA Psychiatry. 2018 Dec 19. doi: 10.1001/jamapsychiatry.2018.3537.

Patients with opioid dependence and anxiety, depression, and insomnia symptoms who receive extended-release naltrexone injections experience similar results to those treated with daily oral buprenorphine-naloxone, research shows. The results suggest that those comorbid symptoms should not prevent a switch from treating patients with an opioid agonist to treating them with extended-release naltrexone, reported Zill-e-Huma Latif, MD, and colleagues.

“Our results showed improvements in anxiety, depression, and insomnia within only a few weeks of beginning either study treatment,” Dr. Latif and colleagues wrote in JAMA Psychiatry. “Our study also showed reductions in the use of opioids and other illegal substances in both treatment groups.”

Dr. Latif and colleagues conducted a prospective, randomized trial of 159 men and women with opioid dependence to receive a 380-mg injectable dose of extended-release naltrexone every 4 weeks or flexible doses (4-24 mg) of daily combined buprenorphine-naloxone for 12 weeks and then a 9-month, open-label period with one of the treatments as chosen by the participant. Of the participants, 105 reached the end of the trial (66%).

The participants were aged 18-60 years and had similar ages, gender distributions, and heroin use duration between treatment groups. The researchers used the 25-item Hopkins Symptom Checklist (HSCL-25) and the Insomnia Severity Index to assess anxiety, depression, and insomnia symptoms every 4 weeks until 48 weeks, reported Dr. Latif, of the department of research and development in mental health at Akershus University Hospital in Norway, and colleagues.

Over 12 weeks of the trial, no differences were found between treatment groups regarding anxiety (effect size, −0.14; 95% confidence interval, −0.47 to 0.19) or depression symptoms scores on the HSCL-25 (ES, −0.12; 95% CI, −0.45 to 0.21). However, the Insomnia Severity Index score was significantly lower among participants taking extended-release naltrexone (ES, −0.32; 95% CI, −0.65 to 0.02; P = .008). In the 9-month, open-label follow-up period, no significant differences were found in anxiety (ES, 0.04; 95% CI, −0.34 to 0.42), depression (ES, −0.04; 95% CI, −0.42 to 0.33), or insomnia (ES, 0.04; 95% CI, −0.33 to 0.42) among participants who switched to extended-release naltrexone or continued using extended-release naltrexone.

“Because participants receiving treatment with [extended-release naltrexone] or [buprenorphine-naloxone] showed equal improvements in anxiety, depression, and insomnia as assessed by the HSCL-25 and the Insomnia Severity Index, such symptoms should not preclude the choice to leave opioid agonist treatment and to start treatment with [extended-release naltrexone],” Dr. Latif and colleagues wrote.

With regard to study limitations, the researchers noted that they used self-reported questionnaires for anxiety, depression, and insomnia symptoms, did not confirm reported drug use through urine samples, and used the HSCL-25 when it is not a diagnostic tool.

The study was funded by grants from the Research Council of Norway and the Western Norway Regional Health Authority; financial support was provided by the Norwegian Center for Addiction Research, University of Oslo, and Akershus University Hospital. The authors report no relevant conflicts of interest.

SOURCE: Latif Z-H et al. JAMA Psychiatry. 2018 Dec 19. doi: 10.1001/jamapsychiatry.2018.3537.

Patients with opioid dependence and anxiety, depression, and insomnia symptoms who receive extended-release naltrexone injections experience similar results to those treated with daily oral buprenorphine-naloxone, research shows. The results suggest that those comorbid symptoms should not prevent a switch from treating patients with an opioid agonist to treating them with extended-release naltrexone, reported Zill-e-Huma Latif, MD, and colleagues.

“Our results showed improvements in anxiety, depression, and insomnia within only a few weeks of beginning either study treatment,” Dr. Latif and colleagues wrote in JAMA Psychiatry. “Our study also showed reductions in the use of opioids and other illegal substances in both treatment groups.”

Dr. Latif and colleagues conducted a prospective, randomized trial of 159 men and women with opioid dependence to receive a 380-mg injectable dose of extended-release naltrexone every 4 weeks or flexible doses (4-24 mg) of daily combined buprenorphine-naloxone for 12 weeks and then a 9-month, open-label period with one of the treatments as chosen by the participant. Of the participants, 105 reached the end of the trial (66%).

The participants were aged 18-60 years and had similar ages, gender distributions, and heroin use duration between treatment groups. The researchers used the 25-item Hopkins Symptom Checklist (HSCL-25) and the Insomnia Severity Index to assess anxiety, depression, and insomnia symptoms every 4 weeks until 48 weeks, reported Dr. Latif, of the department of research and development in mental health at Akershus University Hospital in Norway, and colleagues.

Over 12 weeks of the trial, no differences were found between treatment groups regarding anxiety (effect size, −0.14; 95% confidence interval, −0.47 to 0.19) or depression symptoms scores on the HSCL-25 (ES, −0.12; 95% CI, −0.45 to 0.21). However, the Insomnia Severity Index score was significantly lower among participants taking extended-release naltrexone (ES, −0.32; 95% CI, −0.65 to 0.02; P = .008). In the 9-month, open-label follow-up period, no significant differences were found in anxiety (ES, 0.04; 95% CI, −0.34 to 0.42), depression (ES, −0.04; 95% CI, −0.42 to 0.33), or insomnia (ES, 0.04; 95% CI, −0.33 to 0.42) among participants who switched to extended-release naltrexone or continued using extended-release naltrexone.

“Because participants receiving treatment with [extended-release naltrexone] or [buprenorphine-naloxone] showed equal improvements in anxiety, depression, and insomnia as assessed by the HSCL-25 and the Insomnia Severity Index, such symptoms should not preclude the choice to leave opioid agonist treatment and to start treatment with [extended-release naltrexone],” Dr. Latif and colleagues wrote.

With regard to study limitations, the researchers noted that they used self-reported questionnaires for anxiety, depression, and insomnia symptoms, did not confirm reported drug use through urine samples, and used the HSCL-25 when it is not a diagnostic tool.

The study was funded by grants from the Research Council of Norway and the Western Norway Regional Health Authority; financial support was provided by the Norwegian Center for Addiction Research, University of Oslo, and Akershus University Hospital. The authors report no relevant conflicts of interest.

SOURCE: Latif Z-H et al. JAMA Psychiatry. 2018 Dec 19. doi: 10.1001/jamapsychiatry.2018.3537.