Identifying individual clinical and environmental predictors of buprenorphine response to inform treatment for opioid use disorder

About This Grant

1 Project Summary/Abstract 2 3 Despite evidence that buprenorphine maintenance is an effective treatment for many individuals with opioid 4 use disorder (OUD), nearly half of patients receiving buprenorphine for OUD either return to illicit opioid use or 5 prematurely discontinue treatment. However, we do not know who is unlikely to respond to buprenorphine 6 treatment or why. Filling this knowledge gap is a vital step to designing interventions that best meet the diverse 7 needs of patients receiving treatment for OUD. Individual clinical trials have provided some information about 8 patient characteristics associated with poor buprenorphine treatment response (e.g., previous use of heroin), 9 however, these individual studies are limited in two keyways. First, individual clinical trials are not powered to 10 test the association of a wide range of possibly valuable patient characteristics and treatment outcome, leading 11 to inconsistent sets of variables being tested and reported across clinical trials. Secondly, previous literature 12 has focused nearly exclusively on identifying patient characteristics that are predictive of treatment outcome at 13 the sample level and have not yet evaluated our ability to make treatment predictions at the individual level. 14 The ability to make predictions at the individual level provides an exciting opportunity to address the 15 heterogeneity of patients with OUD by informing individually adaptive interventions that are responsive to the 16 patient's specific needs and risk factors. The current study aims to harmonize data from five clinical trials on 17 buprenorphine maintenance (N=1,439) to answer these questions in an efficient manner by leveraging 18 previously conducted clinical trials. This approach will allow us to examine a wide range of possibly valuable 19 baseline patient characteristics including demographic factors, clinical history (e.g., co-occurring psychiatric 20 problems), and understudied environmental/contextual factors. Results from the current study will provide 21 invaluable information that can be used to elucidate important mechanisms that underly buprenorphine 22 treatment response at the sample level, while also evaluating our ability to identify individual patients who are 23 unlikely to be successful in treatment prior to treatment initiation. Treatment outcome will be defined in two 24 ways (1) the number of days of illicit opioid use in the last month of treatment and (2) the number of weeks 25 receiving buprenorphine doses (i.e., treatment retention). This project will support the applicant's goal of 26 illuminating important patient characteristics and mechanisms that drive treatment response or non-response. 27 To accomplish this goal, the applicant will receive training in psychosocial determinants of response to 28 medication for OUD, psychopharmacological interventions for SUD, clinical trial design and implementation, 29 and the use of advanced longitudinal statistical techniques.