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Clinical Trial Summary

The overall goal of this research project will be to obtain feedback from consumers to help develop a manual called I-DREM (Innovative Development of Research Engagement Manual). The researchers hope to learn information from the consented participants to help map out solutions to improve recruitment of African American/Black individuals into Substance Abuse Disorder (SUD) clinical trials.


Clinical Trial Description

Black individuals represent 12% of the U.S. population, but only 2-3% participate in various clinical trials (Byrne et al., 2014; Murthy et al., 2004). Black individuals are disproportionately affected by substance use and have higher rates of associated mortality, suggesting the need for action to address this racial disparity in health outcomes (Hedegaard et al., 2020). Under-representation of ethnic minorities in clinical trials has significant scientific implications and ultimately compromises generalizability of research findings and further exacerbates existing racial health disparities. Although incremental progress has occurred since the establishment of the National Institutes of Health (NIH) Revitalization Act, barriers that influence participation of the African American and ethnic minority populations in research continue to exist. The NIH has acknowledged the need for increased enrollment of ethnic minorities in research, yet minority enrollment into clinical and translational research remains low (FDA, 2017). There are no concrete developments (e.g., protocols, toolbox) to aid clinical researchers' effort to enhance recruitment and retention to date in substance using populations despite the detrimental disproportionate effects of substance use observed in the African American and or Black populations. This suggests the importance of initiating more innovative ways of retainment, recruitment, and education of ethnic minorities about Substance Use Disorders (SUDs). Specifically, almost 1 million Americans (estimated 977,000) met criteria for cocaine use disorder in 2018 (Hedegaard et al., 2020). The rate of overdose deaths attributed to cocaine increased by an average of 27% each year from 2012-2018, reaching a rate of 4.5 deaths per 100,000 standard population in 2018. This increase is a tripling in deaths from 2012-2018 (Hedegaard et al., 2020), and appears to be continuing to increase (Karisa, 2020). The rate of death is highest among non-Hispanic Blacks at a rate of 8.3 per 100,000 population, which is nearly double the rate of death attributed to cocaine among non-Hispanic Whites. This differential death rate is seen despite similar rates of cocaine use among Blacks and Whites (1.8 % vs 2.1%, respectively in 2018), suggesting the need for action to address this racial disparity in health outcomes (Hedegaard et al., 2020). Significance: Nearly 40% of Americans belong to a racial or ethnic minority group. However, participants in clinical trials for new pharmacotherapies skew heavily Caucasian. In the area of substance use disorders, Blacks are also disproportionally affected and have higher rates of associated mortality. One study using data from multiple Clinical Trials Network trials showed higher rates of combined opiate and stimulant use among Black compared to White adults (Brooks et al., 2013). The rate of death is also highest among Black participants using cocaine at a rate of 8.3 per 100,000 population, which is nearly double the rate of death attributed to cocaine among non-Hispanic Whites. This differential death rate is seen despite similar rates of cocaine use among Blacks and Whites (1.8 % vs 2.1%, respectively in 2018), suggesting the need for action to address this racial disparity in health outcomes (CDC, 2019). In general, Blacks represent 12% of the U.S. population, but only 2-3% participate in various clinical trials (Byrne et al., 2014; Murthy et al., 2004; Olshan et al., 2007; Olstedal et al., 2011). Under-representation of ethnic minorities in clinical trials has significant scientific implications and ultimately compromises generalizability of research findings and further exacerbates existing racial health disparities. Rationale: While significant attention has been devoted to identifying barriers to inclusion, the current proposal seeks to redirect efforts away from documenting barriers and instead towards improved recruitment and retention of Black/African American (AA) individuals into Randomized Clinical Trials (RCTs). This will be achieved by developing a comprehensive and innovative manual that maps out concrete strategies for both increased recruitment and retention in RCTs ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05124119
Study type Observational
Source University of Texas Southwestern Medical Center
Contact Hoa Vo, PhD
Phone 202-956-8387
Email [email protected]
Status Not yet recruiting
Phase
Start date February 28, 2022
Completion date February 28, 2024

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