Trial Outcomes & Findings for Strategies to Enhance Recruitment and Retention of Black Individuals Into Clinical Trials for Substance Use Disorders (NCT NCT05124119)
NCT ID: NCT05124119
Last Updated: 2026-08-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
63 participants
Primary outcome timeframe
Baseline Day 1-15 (prior to Focus Group1) [Approximated time frame]
Results posted on
2026-08-12
Participant Flow
Recruitment of participants will be conducted by phone or virtually by the study staff.
Sixty-five people were Pre-Screened. Two people failed Pre-Screening: one because they did not want to reduce or stop their drug use; one because they did not identify their racial background as Black/African American. Sixty-three participants were Screened. Sixty-two participants participated in Focus Group 1. 49 Participants participated in Focus Group 2.
Participant milestones
| Measure |
Focus Group
Participants in Focus Group 1 will be assigned a unique study name or pseudonym and requested to answer a set of questionnaires that are described in the protocol. A subset of 49 participants from Focus Group 1 also participated in Focus Group 2 and were administered questionnaires that are described in the protocol. 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.
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|---|---|
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Overall Study
STARTED
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63
|
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Overall Study
COMPLETED
|
62
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Focus Group
Participants in Focus Group 1 will be assigned a unique study name or pseudonym and requested to answer a set of questionnaires that are described in the protocol. A subset of 49 participants from Focus Group 1 also participated in Focus Group 2 and were administered questionnaires that are described in the protocol. 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.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
Strategies to Enhance Recruitment and Retention of Black Individuals Into Clinical Trials for Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Focus Group One
n=63 Participants
Participants in Focus Group 1 will be 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. 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.
Participants in Focus Group 2 were a subset of participants in Focus Group 1.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=1 Participants
|
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Age, Categorical
Between 18 and 65 years
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54 Participants
n=1 Participants
|
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Age, Categorical
>=65 years
|
9 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=1 Participants
|
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Race (NIH/OMB)
White
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
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63 participants
n=1 Participants
|
|
Previous participation in substance/drug abuse prevention research
Yes
|
14 Participants
n=1 Participants
|
|
Previous participation in substance/drug abuse prevention research
No
|
47 Participants
n=1 Participants
|
|
Previous participation in substance/drug abuse prevention research
Did not answer
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2 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline Day 1-15 (prior to Focus Group1) [Approximated time frame]Population: Participants who participated in Focus Group 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.
Outcome measures
| Measure |
Focus Group
n=63 Participants
Participants in Focus Group 1 will be 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. 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.
Participants in Focus Group 2 were a subset of participants in Focus Group 1.
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|---|---|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Researchers that represent the participant6s
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Researchers involved in the participant's community
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Must trust the researchers
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Relevance of the research
|
1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Have a comprehensivwe understanding of the research
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Receive detailed information clearly and directly from research team
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Researchers' knowledgeable about the research being conductedc
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
A friendly and warming response from the research team
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
A trusted source recommended the research study
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1 Number of factors identified
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
A desire to help others
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Monetary compensation
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
The need to learn new things, meet new people, and learn from the experience of others
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
Curiosity
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1 Number of factors identified
|
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Identification of Concrete Reasons That Affect the Willingness of Black Individuals With Substance Use Disorder (SUD) Lived Experience to Participate in SUD Research.
The convenience of virtual participation
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1 Number of factors identified
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Adverse Events
Focus Group One
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place