Opioid UseNCT06609278
THRIVE: Culturally AdapTed Harm Reduction Intervention
A study testing harm reduction intervention in people with Opioid Use and Stimulant Use, run by Brittany Miller-Roenigk at 3 sites in United States.
Trial summary
The goal of this study is to develop and test a culturally adapted harm reduction intervention among Black adults who misuse opioids and/or stimulants. The questions it aims to answer include: will the culturally adapted harm reduction educational intervention increase overall knowledge of overdose and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Stimulant Use
- What is being tested?
- harm reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Apr 2025to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as Black or African American
- Currently a resident of study areas
- Report misuse of stimulants and/or opioids in the last six months
Who cannot join
- Do not identify as Black or African American
- If they participated in Aim 1 of the study
- Do not want to be audio-recorded
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Urban Minority Alcoholism and Drug Abuse Outreach Program (UMADAOP) of Cincinnati
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45221
Louisville Central Community Center
Louisville, Kentucky, 40203
About this study
Official title: Culturally AdapTed Harm Reduction Intervention: Community Engaged InterVention for Black Adults That MisusE Opioids and Stimulants
The goal of this study is to develop and test a culturally adapted harm reduction intervention among Black adults who misuse opioids and/or stimulants. The questions it aims to answer include: will the culturally adapted harm reduction educational intervention increase overall knowledge of overdose and prevention/intervention techniques and increase confidence and willingness to use/teach interventions to others at-risk.
Read the detailed description
The overall study design is a mixed methods pilot developing and testing a culturally adapted intervention to enhance knowledge about and motivation to use opioid overdose harm reduction strategies, including Fentanyl Test Strips (FTS) and Narcan. Given the preliminary nature of this pilot study designed to develop an adapted intervention, subjects will not be randomized and there will be no control group or placebo.
Aim 1 is a qualitative design in which investigators will conduct two focus group sessions with a group of up to 8 Black adults who have misused opioids and stimulants in the past 30 days. Participants will be recruited to have about 50% gender and age representation across four cohorts: born 1996-2006; born 1985-1995; born 1974-1984; and born 1960-1973; with one male and one female in each cohort. A semi-structured qualitative focus group format will be utilized for each focus group session to allow for flexibility in asking additional questions based on participant responses. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups. Aim 1 will occur in Louisville, Kentucky (KY) and full study visits will be recorded.
Aim 2 is a cross-sectional mixed method design in which the culturally adapted intervention developed during Aim 1 will be piloted after institutional review board (IRB) modification approval of the intervention among about 48-60 Black adults residing in Louisville, Kentucky and Cincinnati, Ohio (OH). Each study site will recruit three groups of up to 8-10 participants to pilot the intervention, resulting in approximately 6 groups and 48-60 participants. Eligible participants for Aim 2 are aged 18-65 and will be recruited to have approximately 50% male and female members overall but not specific to age cohorts. Participants will complete pre-and post-intervention quantitative measures assessing their motivation and comfort using Narcan and Fentanyl Test Strips (FTS). In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups.
- Conditions
- Opioid Use, Stimulant Use
- Being tested
- harm reduction intervention
- Keywords
- Harm Reduction, Opioid Overdose, Stimulant Misuse, Opioid Misuse, Narcan, Fentanyl Test Strips
- Medical subject headings
- Harm Reduction, Opiate Overdose, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harm reduction interventionBehavioural
Each participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE | Experimental | Participants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and FTS. In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. Receives: Behavioral: harm reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Confidence Using Harm Reduction Techniques at Baseline
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Measured: Baseline
Participant Confidence Using Harm Reduction Techniques Post Intervention
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Measured: Post-intervention (approximately 2 hours)
Participant Willingness to Use Harm Reduction Techniques at Baseline
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Measured: Baseline
Participant Willingness to Use Harm Reduction Techniques Post-intervention
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Measured: Post-intervention (approximately 2 hours)
Participant Comfort to Possess Harm Reduction Techniques Baseline
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
Measured: Baseline
Participant Comfort to Possess Harm Reduction Techniques Post Intervention
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
Measured: Post Intervention (approximately 2 hours)
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Measured: Baseline
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Measured: Post intervention (approximately 2 hours)
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Measured: Baseline
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Measured: Post intervention (approximately 2 hours)
Change in Knowledge of How Overdose Occurs
1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs
Measured: Baseline and post intervention (approximately 2 hours)
Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose
Yes/No/Somewhat with coding 0 = No, 1= Somewhat, 2= yes; score on scale ranged 0-2 with a higher score equating to greater knowledge/confidence how to prevent and intervene with an overdose
Measured: Baseline and post intervention (approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start2 Apr 2025
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brittany Miller-Roenigk
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor-investigator, Brittany Miller-Roenigk, University of Kentucky
- Investigators
- Brittany Miller-Roenigk, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609278
- Sponsor's protocol ID
- 96815
- Other IDs
- UL1TR001998, UL1TR001425
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2024
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally AdapTed Harm Reduction Intervention: Community Engaged InterVention for Black Adults That MisusE Opioids and Stimulants
- ClinicalTrials.gov ID
- NCT06609278
- Acronym / sponsor ID
- 96815
- Conditions
- Opioid Use, Stimulant Use
- Keywords
- Harm Reduction, Opioid Overdose, Stimulant Misuse, Opioid Misuse, Narcan, Fentanyl Test Strips
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Brittany Miller-RoenigkUniversity, hospital or other
- Collaborators
- University of Cincinnati, National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to develop and test a culturally adapted harm reduction intervention among Black adults who misuse opioids and/or stimulants. The questions it aims to answer include: will the culturally adapted harm reduction educational intervention increase overall knowledge of overdose and prevention/intervention techniques and increase confidence and willingness to use/teach interventions to others at-risk.
Detailed description
The overall study design is a mixed methods pilot developing and testing a culturally adapted intervention to enhance knowledge about and motivation to use opioid overdose harm reduction strategies, including Fentanyl Test Strips (FTS) and Narcan. Given the preliminary nature of this pilot study designed to develop an adapted intervention, subjects will not be randomized and there will be no control group or placebo.
Aim 1 is a qualitative design in which investigators will conduct two focus group sessions with a group of up to 8 Black adults who have misused opioids and stimulants in the past 30 days. Participants will be recruited to have about 50% gender and age representation across four cohorts: born 1996-2006; born 1985-1995; born 1974-1984; and born 1960-1973; with one male and one female in each cohort. A semi-structured qualitative focus group format will be utilized for each focus group session to allow for flexibility in asking additional questions based on participant responses. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups. Aim 1 will occur in Louisville, Kentucky (KY) and full study visits will be recorded.
Aim 2 is a cross-sectional mixed method design in which the culturally adapted intervention developed during Aim 1 will be piloted after institutional review board (IRB) modification approval of the intervention among about 48-60 Black adults residing in Louisville, Kentucky and Cincinnati, Ohio (OH). Each study site will recruit three groups of up to 8-10 participants to pilot the intervention, resulting in approximately 6 groups and 48-60 participants. Eligible participants for Aim 2 are aged 18-65 and will be recruited to have approximately 50% male and female members overall but not specific to age cohorts. Participants will complete pre-and post-intervention quantitative measures assessing their motivation and comfort using Narcan and Fentanyl Test Strips (FTS). In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. Individuals are excluded if they do not want to be audio-recorded, since a main component of the study is recording focus groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THRIVE | Experimental | Behavioral: harm reduction interventionParticipants will complete pre- and post-intervention quantitative measures assessing their motivation and comfort using Narcan and FTS. In addition, participants will also participate in a semi-structured qualitative focus group after completing the intervention session to assess harm reduction needs in their community, additional barriers participants expect with the adapted intervention, feasibility of the intervention, and perceived knowledge of opioid overdose and prevention and intervention tools gained from prior to the intervention to afterwards. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identify as Black or African American
- Currently a resident of study areas
- Report misuse of stimulants and/or opioids in the last six months
Key exclusion criteria (3 listed)
- Do not identify as Black or African American
- If they participated in Aim 1 of the study
- Do not want to be audio-recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| harm reduction interventionEach participant will complete a pre-test at Study Visit 1 prior to the intervention, participate in the intervention, then complete a post-test. After the intervention, participants will participate in a recorded focus group. Participants will be offered FTS, Narcan, first aid supplies at the study visit. | Behavioural | THRIVE |
Primary outcome
Participant Confidence Using Harm Reduction Techniques at Baseline
Time frame: Baseline
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Participant Confidence Using Harm Reduction Techniques Post Intervention
Time frame: Post-intervention (approximately 2 hours)
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Participant Willingness to Use Harm Reduction Techniques at Baseline
Time frame: Baseline
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Participant Willingness to Use Harm Reduction Techniques Post-intervention
Time frame: Post-intervention (approximately 2 hours)
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Participant Comfort to Possess Harm Reduction Techniques Baseline
Time frame: Baseline
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
Participant Comfort to Possess Harm Reduction Techniques Post Intervention
Time frame: Post Intervention (approximately 2 hours)
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Baseline
Time frame: Baseline
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Participant Confidence Describing How to Use Harm Reduction Techniques to Others Post Intervention
Time frame: Post intervention (approximately 2 hours)
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Baseline
Time frame: Baseline
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Participant Willingness to Teach Others How to Use Harm Reduction Techniques Post Intervention
Time frame: Post intervention (approximately 2 hours)
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
Change in Knowledge of How Overdose Occurs
Time frame: Baseline and post intervention (approximately 2 hours)
1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs
Change in Perceived Knowledge/Confidence of How to Prevent and Intervene With an Overdose
Time frame: Baseline and post intervention (approximately 2 hours)
Yes/No/Somewhat with coding 0 = No, 1= Somewhat, 2= yes; score on scale ranged 0-2 with a higher score equating to greater knowledge/confidence how to prevent and intervene with an overdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany Miller-Roenigk, PhD principal investigator
University of Kentucky
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing harm reduction intervention in people with Opioid Use and Stimulant Use, run by Brittany Miller-Roenigk at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Confidence Using Harm Reduction Techniques at Baseline (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.