An observational study in Substance Use Disorders, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
Black individuals represent 12% of the U.S. population. Approximately 3% participate in various clinical trials in the entire country. 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. 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. 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, an estimated 977,000, met criteria for cocaine use disorder in 2018. The rate of overdose deaths attributed to cocaine increased by an average of 27% each year from 2012 to 2018, reaching a rate of 4.5 deaths per 100,000 standard population in 2018. This increase is a tripling in deaths from the year 2012 to 2018 and appears to be continuing to increase. 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 is 1.8 % versus 2.1%, respectively in 2018, suggesting the need for action to address this racial disparity in health outcomes.
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. 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 suggests the need for action to address this racial disparity in health outcomes. 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
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 63 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
African American persons, male and female, 18 years to 90 years that have a history of substance abuse disorder and have competed rehabilitation and not actively using illicit drugs.
Exclusion Criteria:
-All that does not meet the inclusion criteria from (i) to (v) above
Participants in Focus Group 1 (n=63) were assigned a unique study name or pseudonym and requested to answer a set of three different questionnaires that are described in the study's protocol after Focus Group 1. A subset of 49 participants also participated in Focus Group 2 and answered the same set of questionnaires after Focus Group 2. This study does not involve any type of intervention. The participants will not be administered any type of medications but only questionnaires. This is an observational (cross-section) type of study and not an experimental or randomized clinical trial.
Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
To conduct focus groups among Black Consumer stakeholders with lived substance use experience to understand the factors that may or may not affect their willingness to participate in prospective substance use disorder (SUD) clinical trials.
Time frame: Baseline Day 1-15 (prior to Focus Group1) [Approximated time frame]
Recruitment of participants will be conducted by phone or virtually by the study staff.
| Milestone | Focus Group |
|---|---|
| Started | 63 |
| Completed | 62 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
To conduct focus groups among Black Consumer stakeholders with lived substance use experience to understand the factors that may or may not affect their willingness to participate in prospective substance use disorder (SUD) clinical trials.
| Number of factors identified | Focus Group |
|---|---|
| Have a comprehensivwe understanding of the research | 1 |
| Receive detailed information clearly and directly from research team | 1 |
| Researchers' knowledgeable about the research being conductedc | 1 |
| A friendly and warming response from the research team | 1 |
| Researchers that represent the participant6s | 1 |
| Researchers involved in the participant's community | 1 |
| Must trust the researchers | 1 |
| Relevance of the research | 1 |
| A trusted source recommended the research study | 1 |
| A desire to help others | 1 |
| Monetary compensation | 1 |
| The need to learn new things, meet new people, and learn from the experience of others | 1 |
| Curiosity | 1 |
| The convenience of virtual participation | 1 |
Collected over Adverse Events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Focus Group One | — | — | — |
All screened participants were included in the analysis population.
| Age, Categorical(Participants) | Focus Group One |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 54 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | Focus Group One |
|---|---|
| Female | 29 |
| Male | 34 |
| Ethnicity (NIH/OMB)(Participants) | Focus Group One |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 63 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Focus Group One |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 63 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Focus Group One |
|---|---|
| United States | 63 |
| Previous participation in substance/drug abuse prevention research(Participants) | Focus Group One |
|---|---|
| Yes | 14 |
| No | 47 |
| Did not answer | 2 |
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Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center