Due to the ever growing concern for illicit opioid abuse, a team of researchers looked at the effectiveness of buprenorphine implant in treating opioid abuse, as compared to stable opioid-dependent patients receiving daily oral buprenorphine treatment. The double-blind trial was conducted at 21 office-based buprenorphine outpatient treatment US sites from June 26, 2014, through May 18, 2015. Participants were randomized to receive oral buprenorphine doses plus 4 placebo implants or sublingual placebo plus four 80mg buprenorphine hydrochloride implants. The results showed that of out 177 participants over 6 months, 72 of 84 (85.7%) receiving buprenorphine implants and 64 of 89 (71.9%) receiving oral buprenorphine, maintained opioid abstinence.
The results did conclude that among adults with opioid dependence maintaining abstinence with a stable dose of oral buprenorphine, the use of buprenorphine implants compared with continued oral buprenorphine did not result in a lower likelihood of responding to the treatment. However, the study population had an exceptionally high response rate in the control group, and further studies are needed in bigger populations to assess the efficacy in different scenarios. The results of the study were published online in JAMA on 19th July, 2016.
Given these results, despite the fact that there isn’t much significant statistical difference between the groups, buprenorphine implants may still prove to be an effective relapse prevention treatment for stable opioid-dependent adults maintaining clinical stability with 8 mg/d or less of oral buprenorphine.
Opioid dependence has been a growing concern in the United States, not only because of the social problems it causes but also because of the many diseases it causes such as human immunodeficiency virus (HIV) and hepatitis C and fatal overdose when left untreated. Medical intervention is far more effective at curbing this growing issue than psychological intervention techniques such as group therapy, cognitive behavioral therapy (CBT) or drug policies. Moreover, since only 3 available medications—methadone, buprenorphine, and naltrexone—are approved for treatment of opioid dependence, more research and scientific advancements are required.
The researchers believed that a 6-month buprenorphine implant may improve treatment outcomes, improve rates of opioid abstinence, reduce risks of abuse, diversion and accidental exposure to kids. Previously, little research has been done to investigate the long-term practicality of using buprenorphine implants to abstain users for illicit opioid use. This study demonstrated the effectiveness and practicality of buprenorphine implants in treatment of patients maintaining clinical stability with oral buprenorphine in comparison with an active control; preliminary evidence of efficacy relative to placebo was previously demonstrated by reducing opioid use in patients initiating buprenorphine treatment in double-blind, phase 3, placebo-controlled trials.
Since there is not much data available on the stability of patients undergoing oral buprenorphine, it is quite vital to track the health and improvement progress of patients who achieve good clinical response to initial buprenorphine treatment. When compared to patients receiving oral treatment methods, participants receiving buprenorphine implants were more likely to sustain abstinence from illicit opioids from month 3 through month 6. At a 6-month cumulative end point, 85.7% of the buprenorphine implant group was abstinent relative to 71.9% of the oral buprenorphine group.
Buprenorphine is an effective treatment for opioid abuse but delivering daily dose for managing chronic diseases is quite challenging. Hence the researchers concluded that an implantable buprenorphine delivery system reduces adherence issues, improves efficiency and reduces risk of relapse. Although very few participants experienced relapses to opioid use during the 6 months of the study, statistically significant differences in time to first illicit opioid use between the buprenorphine implant and oral buprenorphine groups demonstrated sustained abstinence.
A limitation of this study was that it was not well-equipped to detect differences in adverse outcomes. Moreover, there was not much diversity in the participants since they all were white, employed, with at least a high school education and dependent on prescription opioids. A topic for future discussion could be focused on determining the rate and predictors of relapse after discontinuation of implant treatment. Thus, it is important to study the feasibility of longer-term patient treatment with 6-month implant replacement.
This is not the first time that buprenorphine implant treatment was considered for illicit opioid abuse. The US Food and Drug Administration (FDA) approved a subdermal (a patch placed under the skin) buprenorphine skin implant for the treatment of opioid dependence. They announced their decision on 26 May, 2016. As part of a new drug treatment program, chemists have designed probuphine as a method for low dosage buprenorphine delivery for six months in patients who have shown stability while on mild to moderate dosage of the drug. This decision was reached after an independent FDA advisory committee supported the approval of probuphine in a meeting held earlier this year. Before this decision was made, buprenorphine was delivered in a pill format or film placed under the tongue or side of a person’s cheek.
Hence a lot of research is being conducted and many big health policy offices are looking to turn to this unique piece of technology to curb the growing issue of drug abuse, as compared to traditional techniques such as group therapy, cognitive behavioral therapy (CBT) or improved drug reforms.