Adults being treated for opioid dependence report high satisfaction with buprenorphine injectables, in new findings that researchers say could help improve the treatment and management of opioid-dependent patients.
In the BEGINNING trial, patients receiving weekly or monthly buprenorphine deposition had significantly higher overall satisfaction with treatment, a reduced treatment burden, and a higher quality of life than peers receiving daily treatment with sublingual buprenorphine.
“The study’s focus on patient-reported outcomes (PRO) may help better inform patients and physicians when selecting treatment options than traditional clinical outcomes of addiction treatment studies. ‘opioids,’ said lead researcher Fredrik Tiberg, PhD, president and CEO of Camurus, a said pharmaceutical company in Lund, Sweden Medscape Medical News.
“Positive experiences of patients with buprenorphine injection in storage reported in the DEBUT study indicate that long-acting treatments could help advance the quality of care and access to treatment for patients with opioid dependence / use, ”Tiberg said.
The study was published online May 10 a JAMA network open.
The study was a randomized controlled trial in open and parallel group that included 119 patients from six outpatient clinics in Australia; 60 received weekly or monthly buprenorphine and 59 received sublingual buprenorphine for 24 weeks.
The primary outcome was overall treatment satisfaction, as measured by the 14-question drug satisfaction questionnaire (TSQM) at the end of the study at week 24.
The study reached its primary endpoint with a significantly higher overall TSQM satisfaction score among adults who received depot injections compared with those who received sublingual buprenorphine (mean score 82.5 vs. 74.3; difference, 8.2; 95% CI, 1.7 – 14.6; P = .01).
An improvement was also observed in several secondary outcomes, including decreased treatment burden and increased quality of life.
The safety profile was consistent with the known safety profile of buprenorphine, apart from the transient reactions of the mild to moderate injection site.
“To our knowledge, this is the first randomized study to use a series of PROs to compare the results between a long-acting injection and daily dosing of buprenorphine in the treatment of opioid dependence,” the researchers note. .
“The study highlights the application of PROs as alternative endpoints to traditional markers of substance use in studies of addiction treatment outcomes,” they conclude.
Giving voice to patients
In a guest comment, Nora D. Volkow, MD, director of the National Institute of Drug abuse, and Wilson M. Compton, MD, deputy director of NIDA, point out that the “patient’s voice” has been lacking in most of the work on drug development, including opioid use disorder.
The current study treats this issue in a “well-designed and executed” way and the results “consistently demonstrate” the superiority of injectable buprenorphine in many outcomes.
The study highlights the importance of considering PRO measures in clinical trials, according to Volkow and Compton.
“Even if the efficacy is not different for several formulations, PROs can provide an important reason for selecting a new formulation. Patient preferences and seemingly improved function may be useful secondary outcomes in drug trials, and the measures used in this new study deserve to be considered, “they write.
In addition, increased treatment satisfaction by patients receiving long-release buprenorphine suggests that these formulations “may help improve long-term retention and, as such, be a valuable tool to help combat the current opioid epidemic and reduce its associated mortality “. they conclude.
This study was supported by Camurus AB. Tiberg is President and CEO of Camurus AB. The full list of author disclosures is found in the original article. Volkow and Compton have not revealed any relevant financial relationship.