Patients report subcutaneous buprenorphine preferable to sublingual formulation
Patients with opioid dependence who received subcutaneous buprenorphine reported higher satisfaction and lower treatment burden vs. those who took sublingual buprenorphine, according to results of a randomized clinical trial.
“No study has compared patient-reported outcomes (PROs) between treatment with depot buprenorphine and [sublingual] buprenorphine in a randomized clinical trial (RCT),” Nicholas Lintzeris, MBBS, PhD, a professor of addiction medicine at the University of Sydney, director of drug and alcohol services at the South Eastern Sydney Local Health District and chair of the New South Wales Drug and Alcohol Clinical Research and Improvement Network, and colleagues wrote in JAMA Network Open. “Furthermore, the previous double-masked RCTs of depot buprenorphine required all participants to attend services to receive the active or placebo medication to maintain masking, thus obscuring potential differences in patient experiences.”
Lintzeris and colleagues conducted an open-label, RCT of 119 adults (58.8% men; mean age, 44.4 years) from six outpatient sites in Australia who were receiving sublingual buprenorphine at the time of enrollment for opioid dependence. The researchers randomly assigned 60 participants to switch to subcutaneously administered depot buprenorphine and 59 participants to continue treatment with sublingual buprenorphine.
The study’s primary endpoint was Treatment Satisfaction Questionnaire for Medication (TSQM) scores at week 24. One of the secondary outcome measures was treatment burden, as assessed by the Treatment Burden Questionnaire.
Patients in the depot buprenorphine group reported a mean TSQM score of 82.5, which was “significantly higher” than the mean score of 74.3 among the sublingual group at week 24, indicating greater satisfaction with subcutaneous treatment, according to the researchers.
In addition to greater satisfaction, patients in the depot buprenorphine group had lower treatment burden, with a mean Treatment Burden Questionnaire global score of 13.2 vs. 28.6 in the sublingual buprenorphine group.
Among the depot buprenorphine group, 65% of patients experienced adverse drug reactions, which were “mainly injection site reactions of mild intensity following subcutaneous administration,” vs. 20.3% of patients in the sublingual buprenorphine group, according to the researchers. They also wrote that no participants withdrew due to adverse events.
“Missing from most of the work in medication development, including for opioid use disorder, has been the voice of the patient. What do patients want? How do they respond to the various approaches to treatment?” Wilson M. Compton, MD, MPE, and Nora D. Volkow, MD, both of the National Institute on Drug Abuse, wrote in an invited commentary. “While there may be modest variations in adverse effects and tolerability in general for the different formulations, the underlying pharmacology is generally identical,” which means that “differences are expected to be in their use in practice.”
Therefore, the use of PROs in clinical trials is important, according to Compton and Volkow.
“Even if efficacy is no different for various formulations, PROs may provide an important reason to select a new formulation,” they wrote. “Patient preferences and apparently improved function may prove to be useful secondary outcomes in medication trials, and the measures used in this new study deserve consideration.”
- Compton WM, et al. JAMA Netw Open. 2021;doi:10.1001/jamanetworkopen.2021.9708.
- Lintzeris N, et al. JAMA Netw Open. 2021;doi:10.1001/jamanetworkopen.2021.9041.