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Clinical Question
Is injectable extended-release naltrexone as effective as daily oral buprenorphine-naloxone for preventing relapse in adults with opioid dependence?
Bottom line
Injectable extended-release (ER) naltrexone administered every 4 weeks is similar in efficacy to daily oral buprenorphine-naloxone for the treatment of opioid dependence. Patients using ER naltrexone reported higher satisfaction with treatment and were more likely to recommend it to others. 1b-
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Foundation
Setting: Outpatient (specialty)
Synopsis
The use of oral medications to treat opioid dependence is fraught with low adherence and a high dropout rate. These investigators identified 159 adults, aged 18 years to 60 years, who met standard diagnostic criteria for opioid dependence. Study participants randomly received (concealed allocation assignment) oral buprenorphine-naloxone 4 mg to 24 mg per day administered in a controlled environment or intramuscular ER naltrexone 380 mg every 4 weeks. Although individuals who assessed outcomes were not masked to treatment group assignments, individual primary outcomes were objective and minimally prone to biased reporting (eg, study retention rate, number of days with negative urine drug tests (UDTs), number of days of heroin and other illicit opioid use). Missing UDTs were considered positive for opioids. Complete follow-up occurred for 66% of participants at 12 weeks. More individuals in the daily buprenorphine-naloxone group failed to complete follow-up than in the ER naltrexone group. (23 vs 15, respectively). Using intention-to-treat analysis, no significant differences occurred between the ER naltrexone group and the oral buprenorphine-naloxone group in study retention time, negative opioid UDTs, and days of use of heroin and other illicit opioids. Similarly, no group differences occurred in the use of amphetamines, cocaine, alcohol, cannabis, or injected drugs. Significantly more patients in the ER naltrexone group had a reduction in days of benzodiazepine use and higher reported satisfaction, and significantly more were likely to recommend their treatment to others. No significant differences occurred in dropout rates due to adverse events.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Glad to see poems relevant to addiction medicine. Worth noting that there can be some additional challenges with ER Naltrexone (XRNT) not mentioned in the poem. In a previous study one of the greatest challenges using XRNT was initiating treatment. This was due in large part to the necessity of a full detoxification (7-10days) from opiates before initiating XRNT, which lead to patients dropping out of the process early on. This can also make it more difficult to transition patients already on oral agonist treatments (e.g., buprenorphine/naloxone & methodone) to XRNT. Other things to consider with XRNT is how to handle pain management while on it and specific adverse reactions (e.g., injection site reactions).
I need to find out more but looks like hopeful finding
Unfortunately this injectable is not covered in BC
This might be a great advance in treatment.
The stigma of daily pharmacy visits is reduced with one monthly injection.
nice to see addiction addressed.It is so prevalent.keep up the good work
issues on funding, esp. for indigenous its
Excellent