Extended-Release naltrexone hydrochloride (Vivitrol) versus oral buprenorphine– naloxone hydrochloride (Suboxone) – which is the safest and best treatment modality for opioid addiction?
The debate among addiction experts regarding the efficacy and safety of different medication assisted treatment (MAT) options is far from being settled. Until now, extended-release naltrexone hydrochloride (Vivitrol) has not been empirically compared with daily oral buprenorphine–naloxone hydrochloride (Suboxone) in reducing the use of opioids and other addictive intoxicants.
Recently, Tanum, et al (JAMA, 2017) did a two-month, head-to-head, randomized clinical trial comparing the efficacy of both medications in reducing use and relapse among opioid-addicted adults. Investigative end points included trial completion rate, the proportion of opioid-negative urine drug tests, and total days of heroin and opioid use. Secondary end points measured the total days using other psychoactive substances. Adverse events were also recorded and analyzed.
The results didn’t tell us much.
Sixty-six percent of participants completed the trial. Treatment with extended-release naltrexone showed non-inferiority to buprenorphine-naloxone on group proportion of total number of opioid-negative urine drug tests (mean [SD], 0.9 (0.3) and 0.8 (0.4), respectively, difference, 0.1 with 95% CI, -0.04 to 0.2; P < .001) and use of heroin (mean difference, -3.2 with 95% CI, -4.9 to -1.5; P < .001) and other illicit opioids (mean difference, -2.7 with 95% CI, -4.6 to -0.9; P < .001).
Superiority analysis showed significantly lower use of heroin and other opioids in the extended-release naltrexone group. No significant differences were found between the treatment groups regarding the use of other intoxicants.
Why Does This Matter?
A two-month trial for a medication to treat a chronic and often fatal brain disease doesn’t tell us much. The statistical differences in outcome after two months might be drastically different at a one, three or five year-follow up.
Treatment must always be patient-centered and individualized because the pharmacokinetics among individuals are unique, and patients will respond differently to the same medications. Clinical trials for cancer treatments, anti-hypertensives and most cardiovascular drugs provide five-year outcomes. Yet addictive disease, especially the current opioid epidemic, has a high mortality rate, especially among adolescents and young adults. If you measure “Years of Potential Life Lost” (YPLL), opioid use disorder is number one.
We must invest in both high-quality research, prevention and new treatment modalities if we ever hope to stem the tide of this insidious disease.