This is potentially a landmark study published in the October 18, 2017 issue of JAMA Psychiatry that looks at whether a monthly injection of naltrexone (Vivitrol (TM)) is as effective as daily buprenorphine-naloxone (Suboxone(TM)).
This study concluded that in the short-term
Monthly naltrexone shots (Vivitrol) worked as well as daily buprenorphine/naloxone (Suboxone) for treating opioid use disorder, according to the first head-to-head trial between the two.
The study suggests that extended-release naltrexone seems to be as safe and effective as buprenorphine/naloxone for maintaining short-term abstinence from heroin, opioids, and other illicit substances in opioid-dependent individuals newly detoxified and/or discharged from inpatient treatment or prison.
There are still some people who are skeptical of the article and although the study wasn’t directly funded outright by Alkermes, the maker of Vivitrol, the company was reportedly “allowed to comment on the manuscript before submission for publication.” This was reported in the study’s disclosure section.
From Medpage Today
Earlier this year, investigative reporters alleged that Alkermes was using lobbyists to get Vivitrol written into state laws about opioid abuse treatment, and has persuaded drug courts to mandate Vivitrol over other drugs.
For the study, the researchers enrolled 159 patients with opioid dependence (mean age 36; 28% were women) who went through detoxification and were then randomized to buprenorphine/naloxone 4 to 24 mg/day (with a target dose of 16 mg/day) or to monthly naltrexone injections (380 mg).
After 12 weeks, 105 (66%) participants had attended all scheduled follow-up appointments and had taken their medication as prescribed. A total of 53 participants dropped out: 24 in the naltrexone group and 29 in the buprenorphine/naloxone group.
In addition to non-inferiority for retention, naltrexone was also non-inferior for:
- Number of opioid-negative urine drug tests (mean 0.9 and 0.8, respectively; P<0.001)
- Use of heroin (mean difference −3.2, P<0.001)
- Use of other illicit opioids (mean difference −2.7, P<0.001)
Extended-release naltrexone was superior for lower use of heroin and other illicit opioids, but not superior for the proportion of negative urine drug tests.
In terms of secondary outcomes, there were no significant differences between groups for the use of amphetamines, cocaine, alcohol, cannabis, or injecting drugs, but those on naltrexone had a significant reduction in benzodiazepine use, while the buprenorphine/naloxone group remained stable.
There were more adverse events among those on naltrexone (69% versus 34.7%, P<0.001), but only 10 participants discontinued treatment owing to adverse events: four in the naltrexone group and six in the buprenorphine/naloxone group. A number of events were related to withdrawal symptoms and were more frequent among the naltrexone group (28 patients, 39.4%, versus 10 patients, 13.9%).
There were no deaths, but more naltrexone patients reported having serious adverse events including pneumonia and withdrawal (8.5% versus 4.2%).
Tanum and colleagues noted that naltrexone induction required full detoxification to a greater extent than buprenorphine/naloxone treatment. In fact, the detoxification protocol was changed a year into the trial, which reduced the number of new adverse events related to naltrexone induction.
The researchers noted that the study was limited by a lack of blinding, as the use of placebo among newly detoxified opioid users was considered unethical. Also, participants likely recognized their treatment easily, given their long experience with opioid use.