Last month, a long-awaited research study was published that will help patients and physicians make decisions on which treatment to use for opioid dependence. For quite some time, Suboxone®, (Buprenorphine combined with Naloxone) has been the most recommended type of treatment for Opioid Use Disorder. Suboxone® is a partial agonist, which means it turns on the opiate receptors, and so it is quite addictive. For many patients it works well to keep them off of heroin and other street drugs. But Suboxone® has a number of problems. It is highly addictive and many people abuse it. Suboxone® has a very prolonged and painful withdrawal period, so it is extremely hard for patients to detoxify off of it when they want to become completely abstinent. Many patients continue to use opioids even when they are taking their Suboxone®, and other patients drop out of treatment and continue using their street drugs.
Here at The Coleman Institute, we usually recommend Naltrexone implants or monthly Naltrexone Injections (Vivitrol®) as an alternative to Suboxone®. Naltrexone is a pure antagonist. It does not cause any high and it is not addictive. It blocks the endorphin receptors, so it dramatically reduces cravings and relapse rates. Even though we have seen great success with these products, there has not previously been much long-term research to determine just how well Naltrexone works and how it compares to Suboxone®.
The X:BOT study was designed to answer these questions and now the results have been published. X:BOT is an acronym for Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment. It was a large study of 570 patients that was funded by the National Institute of Drug Abuse (NIDA) and was conducted at 8 different sites in the US over a two and half year period. Patients who were looking for treatment for opioid dependence were randomly put on treatment with either Vivitrol® or Suboxone®. At the beginning of the study, they were kept in a hospital long enough for them to detoxify, so they could start their medicines. After induction onto their treatment, the patients were followed for 24 weeks. The study was designed to see how many people continued with their treatment, how many people relapsed, and how many resulted in overdoses and/or fatalities.
The results were quite interesting. As expected, many patients were not able to start Vivitrol®. In order to begin any Naltrexone therapy, whether Naltrexone implants or Vivitrol®, the patient has to be completely detoxed beforehand. Even though the patients were kept in a hospital with medicines prescribed to help them, 28% of the patients could not complete their detox. Since they could not begin receiving Vivitrol®, they quickly relapsed. Suboxone® is much easier to begin because patients do not have to go through withdrawal first. Patients are merely switching from one opiate to another. As a result, 94% of the patients were able to begin their Suboxone® treatment.
However, for the 72% of patients who were able to start on Vivitrol®, the results were very encouraging. More patients taking Vivitrol® completed the study – 47% of the Vivitrol® patients versus 43% of the patients who were taking Suboxone®. Fewer patients who were taking Vivitrol® relapsed – 52% versus 56%. The patients on Vivitrol® reported many more days when they were opiate free – 123 days versus only 87 opiate-free days for the Suboxone® patients. The authors of the study concluded that the two treatments were equally effective because some of these differences were too small to be statistically significant, but I think the study is very favorable for Vivitrol®. Both medicines were equally safe. There were 5 fatal overdoses, 3 in the Suboxone® group and 2 in the Vivitrol® group. All of them occurred in people who had dropped out of the study. One of the main conclusions of the study was that Vivitrol® is an effective treatment, but the main challenge with Vivitrol® is getting people detoxed so they can begin the treatment.
At the conclusion of the study, the authors say that for the patients who were able to start on either Vivitrol® or Suboxone®, the treatments are equally effective and safe. But this is not quite true, because one group is being treated with a very addictive drug and the other group is being treated with a blocking drug. At the end of the study, the Suboxone® patients are still dependent on an opioid that is very difficult to detoxify off of. On the other hand, the patients who were treated with Vivitrol® and stayed on it throughout the study, are drug free. Many of the patients taking Vivitrol® had also been drug-free for 6 months and well on their way to long term recovery.
Peter R. Coleman, MD