An interventional study of harm reduction intervention in Opioid Use and Stimulant Use, sponsored by Brittany Miller-Roenigk. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Brittany Miller-Roenigk · Not applicable, Interventional, and Prevention
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.
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.
115 studies on the registry are indexed under Harm Reduction; 39 are open to participants now.
This study's enrollment of 63 is below the median of 139 across 92 interventional studies indexed under Harm Reduction.
Browse Harm Reduction studies →This is the only study on the registry with Brittany Miller-Roenigk as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: harm reduction intervention
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Baseline and post intervention (approximately 2 hours)
Aim 1 consisted of the Community Advisory Board (CAB). CAB reviewed the intervention and provided feedback in a focus group capacity only; CAB was not enrolled as participants in the clinical trial.
| Milestone | THRIVE |
|---|---|
| Started | 63 |
| Community advisory board | 6 |
| Received thrive intervention | 57 |
| Completed | 63 |
| Not completed | 0 |
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
| score on a scale | THRIVE |
|---|---|
| Fentanyl Test Strips (FTS) | 5.43 ± 3.70 |
| Narcan | 6.61 ± 3.61 |
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
| score on a scale | THRIVE |
|---|---|
| Fentanyl Test Strips (FTS) | 8.36 ± 2.90 |
| Narcan | 8.36 ± 2.90 |
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
| score on a scale | THRIVE |
|---|---|
| FTS | 6.02 ± 3.78 |
| Narcan | 7.86 ± 3.39 |
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
| score on a scale | THRIVE |
|---|---|
| FTS | 8.46 ± 2.87 |
| Narcan | 8.68 ± 2.67 |
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
| score on a scale | THRIVE |
|---|---|
| FTS | 7.26 ± 3.53 |
| Narcan | 7.70 ± 3.39 |
Comfort will be measured by a pre - post test survey with a Likert type scale measured from 1 (not comfortable) to 10 (very comfortable).
| score on a scale | THRIVE |
|---|---|
| FTS | 8.70 ± 2.55 |
| Narcan | 8.49 ± 2.92 |
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
| score on a scale | THRIVE |
|---|---|
| FTS | 6.35 ± 3.81 |
| Narcan | 6.88 ± 3.85 |
Confidence will be measured by a pre - post test survey with a Likert type scale measured from 1 (not confident) to 10 (very confident).
| score on a scale | THRIVE |
|---|---|
| FTS | 8.33 ± 2.81 |
| Narcan | 8.68 ± 2.49 |
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
| score on a scale | THRIVE |
|---|---|
| FTS | 7.25 ± 3.66 |
| Narcan | 7.54 ± 3.62 |
Willingness will be measured by a pre - post test survey with a Likert type scale measured from 1 (not willing) to 10 (very willing).
| score on a scale | THRIVE |
|---|---|
| FTS | 8.44 ± 2.73 |
| Narcan | 8.67 ± 2.55 |
1 = yes, 0 = no; score on scale ranged 0-1 with a higher score equating to more greater knowledge of how overdose occurs
| score on a scale | THRIVE |
|---|---|
| Baseline | .8 ± .4 |
| Post intervention | .95 ± .23 |
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
| score on a scale | THRIVE |
|---|---|
| Baseline | 1.33 ± .72 |
| Post intervention | 1.89 ± .36 |
Collected over 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| THRIVE | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
This participant count include 57 participants who received the THRIVE Intervention and the 6 participants from the Community Advisory Board (CAB). The CAB was not analyzed.
| Age, Categorical(Participants) | THRIVE |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 58 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | THRIVE |
|---|---|
| Female | 27 |
| Male | 36 |
| Race (NIH/OMB)(Participants) | THRIVE |
|---|---|
| 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) | THRIVE |
|---|---|
| United States | 63 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2025 to primary completion in Jun 2025, 2 months.
Results were first posted in May 2026, 10 months after primary completion.
Of 54 non-industry interventional studies with no phase under Harm Reduction, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 2 months is below that.
Counting every sponsor, half of 57 studies reached it within 28 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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