This is John H Kleschinsky's Typepad Profile.
Join Typepad and start following John H Kleschinsky's activity
Join Now!
Already a member? Sign In
John H Kleschinsky
Recent Activity
Hi David, Thank you for reading The BASIS and for providing some thoughtful feedback on my review. I’m going to do my best to reply to each comment in order. I agree with the authors that although these are distinct forms of treatment, extended-release naltrexone being an antagonist and buprenorphine being a partial agonist the comparative data will be helpful to the field. It is worth noting that extended release naltrexone has already been compared to placebo and to treatment as usual. You are correct in pointing out varying induction protocols as a study limitation. I hope that limitation and the overall findings raises awareness about the need for the use of evidence-based strategies for induction. They assessed relapse at any point after day 20 post-randomization. They defined relapse as the use of non-study opioids. Participants were identified as having relapsed if any of the following occurred: a positive screen for non-study opioids on a urine test or failure to provide urine for screening; 7 consecutive days of self-reported non-study opioid use; or 4 consecutive weeks with any non-study opioid use. To your specific question about naltrexone patient relapse, I think both types of relapse are captured based on my reading of how they assessed for relapse. I’m glad to see you went back to the source materials for this study review. We make sure to include a link to at least the abstract, and where available the full publicly available article for those who want to dig deeper into the studies that we review at The BASIS. For the sake of brevity, we try to focus on one or two findings from each study. For this review I chose to focus on induction challenges and relapse with a focus on the intention-to-treat analysis (including in the analysis those who relapsed during induction) and not the per-protocol analysis (removing from analysis those that relapsed during induction) that you highlighted. Reason being, I was interested to report on induction in a community setting with these two treatment options. What I’ve seen and heard about extended-release naltrexone in the past focused on treatment in the criminal justice system, which is a more controlled setting. The title and study are framed, to borrow a phrase from a colleague, as a horse-race. That’s probably not the most constructive way to think about it, which gets back to one of your earlier comments. Having reviewed this article and read your comments, I believe both have a role to play in treating an opioid use disorder. However, we cannot ignore the fact that the extended-release naltrexone group experienced four and a half times as many incomplete inductions compared to the buprenorphine-naloxone group. I believe it is fair to include those in the analysis assessing effectiveness of each drug. Look forward to reading more of our perspective David. Thanks - John
John H Kleschinsky is now following The Typepad Team
Dec 4, 2015