Diversity inclusion in United States opioid pharmacological treatment trials: A systematic review.

Abstract

Pharmacological treatments for opioid use disorders (OUDs) may have mixed efficacy across diverse groups, i.e., sex/gender, race/ethnicity, and socioeconomic status (SES). The present systematic review aims to examine how diverse groups have been included in U.S. randomized clinical trials examining pharmacological treatments (i.e., methadone, buprenorphine, or naltrexone) for OUDs. PubMed was systematically searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The initial search yielded 567 articles. After exclusion of ineligible articles, 50 remained for the present review. Of the included articles, 14.0% (n = 7) reported both full (i.e., accounting for all participants) sex/gender and race/ethnicity information; only two of those articles also included information about any SES indicators. Moreover, only 22.0% (n = 11) reported full sex/gender information, and 42.0% (n = 21) reported full racial/ethnic information. Furthermore, only 10.0% (n = 5) reported that their lack of subgroup analyses or diverse samples was a limitation to their studies. Particularly underrepresented were American Indian/Alaska Native (AI/AN), Asian, Native Hawaiian/Other Pacific Islander (NH/OPI), and multiracial individuals. These results also varied by medication type; Black individuals were underrepresented in buprenorphine randomized controlled trials (RCTs) but were well represented in RCTs for methadone and/or naltrexone. In conclusion, it is critical that all people receive efficacious pharmacological care for OUDs given the ongoing opioid epidemic. Findings from the present review, however, support that participants from diverse or marginalized backgrounds are underrepresented in treatment trials, despite being at increased risk for disparities related to OUDs. Suggestions for future research are advanced.