Harm Reduction Intervention for Opioid and Stimulant Use

No longer recruiting at 2 trial locations

Overseen By Brittany Miller-Roenigk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brittany Miller-Roenigk

Disqualifiers: Not Black, Aim 1 participant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new harm reduction program, the Culturally AdapTed Harm Reduction Intervention, designed specifically for Black adults who misuse opioids and stimulants. The goal is to determine if the program increases knowledge about preventing overdoses and boosts confidence in using and teaching these skills. Participants will share their thoughts in group discussions and complete surveys about their experiences before and after the program. This trial suits Black or African American individuals who have misused opioids or stimulants in the past six months and are willing to be recorded during discussions. As an unphased trial, this study offers a unique opportunity to contribute to culturally tailored harm reduction strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this harm reduction intervention is safe?

Research has shown that harm reduction strategies are generally safe and well-received. These methods have successfully improved health for people who use drugs. Harm reduction practices have been proven to lower health risks and enhance safety in many communities. While this specific program is tailored to fit cultural needs, similar harm reduction methods have not been linked to major safety issues. Although specific safety data for this new program is not yet available, existing harm reduction strategies suggest it should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Culturally AdapTed Harm Reduction Intervention because it offers a unique approach to addressing opioid and stimulant use. Unlike standard treatments that might focus solely on cessation or medical management, this intervention emphasizes harm reduction by improving participants' motivation and comfort in using life-saving tools like Narcan and Fentanyl Test Strips (FTS). Additionally, it involves community engagement through focus groups to better understand local needs and barriers, making the intervention more culturally relevant and tailored. This personalized and community-focused approach holds promise for enhancing the effectiveness and acceptance of harm reduction strategies in diverse populations.

What evidence suggests that this culturally adapted harm reduction intervention is effective for opioid and stimulant misuse?

Research has shown that harm reduction strategies can lower the risks associated with opioid and stimulant misuse. These strategies focus on teaching people how to prevent and respond to overdoses. For example, participants learn to use Narcan, a medication that can reverse opioid overdoses, and fentanyl test strips, which detect fentanyl in drugs. This trial will evaluate the THRIVE program, a culturally adapted harm reduction intervention. Early results indicate that culturally adapted programs, like THRIVE, can enhance understanding and confidence in using these methods. By customizing the program for Black adults, it aims to make the education more relevant and effective for these communities. This approach has shown promise in encouraging participants to use and share these life-saving techniques. ^{1 2 3 6 7}

Who Is on the Research Team?

Brittany Miller-Roenigk, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for Black adults who misuse opioids and stimulants. It's designed to see if a tailored educational program can help them understand more about overdose prevention and make them feel more confident in using or teaching these lifesaving techniques.

Inclusion Criteria

Identify as Black or African American

Currently a resident of study area

Report misuse of stimulants and opioids in the last 30 days

Exclusion Criteria

Do not identify as Black or African American

Participated in Aim 1 of the study

I do not wish to be audio-recorded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Focus Group Sessions

Conduct two focus group sessions with up to 8 Black adults who have misused opioids and stimulants in the past 30 days

2 weeks

2 visits (in-person)

Intervention Pilot

Pilot the culturally adapted intervention with pre- and post-intervention quantitative measures and a qualitative focus group

4 weeks

1 visit (in-person) per group

Follow-up

Participants are monitored for changes in confidence, willingness, and comfort using harm reduction techniques

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Culturally AdapTed Harm Reduction Intervention

Trial Overview The study is testing a culturally adapted harm reduction intervention. This means they're trying out an educational program that's been specially designed to fit the cultural needs of Black individuals struggling with opioid and stimulant misuse.

How Is the Trial Designed?

Group I: THRIVE Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brittany Miller-Roenigk

Lead Sponsor

Trials

1

Recruited

60+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

Published Research Related to This Trial

A Collaborative Board meeting with Elders, cultural leaders, and individuals with lived experience from over 25 AI/AN communities focused on creating a culturally relevant intervention to improve the delivery of medications for opioid use disorder (OUD).

The discussions emphasized the importance of integrating traditional healing practices and family involvement in recovery strategies, highlighting a strength-based and holistic approach to addressing OUD in AI/AN communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Hirchak, KA., Nadeau, M., Vasquez, A., et al.[2023]

Harm reduction strategies, such as syringe exchange programs, have proven effective in reducing HIV transmission among people who inject drugs, with around 200 programs currently operating in the USA.

Despite the success of harm reduction methods like methadone and buprenorphine for treating opioid use disorders, political resistance and stigma surrounding drug use continue to hinder the expansion of these services, especially in suburban and rural areas facing an opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm reduction in the USA: the research perspective and an archive to David Purchase. Des Jarlais, DC.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06609278

THRIVE: Culturally AdapTed Harm Reduction Intervention | ... 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 ...

2. withpower.com withpower.com/trial/phase-stimulant-use-2025-f1742

Harm Reduction Intervention for Opioid and Stimulant Use 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.

3. reporter.nih.gov reporter.nih.gov/search/V1jUuzNg_Ua4xCfy2-_l5w/project-details/10590442

jordan, ayana - NIH RePORTER To tackle these unique problems, we created an integrated harm reduction intervention (IHRI) to be mobile and flexible to the needs of Black and Latinx PWUD.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06609278/thrive-culturally-adapted-harm-reduction-intervention?state=KY&city=Louisville

THRIVE: Culturally AdapTed Harm Reduction Intervention 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.

5. link.springer.com link.springer.com/article/10.1007/s11469-024-01373-2

A Scoping Review of the Utilization of Opioid Use ... The review specifically focused on access to and uptake of medications for opioid use disorder (MOUD) and harm reduction resources.

6. sciencedirect.com sciencedirect.com/science/article/pii/S037687162500050X

A scoping review of harm reduction practices and ... We conducted a scoping review of primary studies regarding drug use harm reduction approaches among Indigenous communities in Australia, Canada, New Zealand, ...

7. mattersnetwork.org mattersnetwork.org/efficacy-of-harm-reduction/

Efficacy of Harm Reduction Harm reduction strategies have repeatedly demonstrated their effectiveness in improving health outcomes for PWUD and mitigating broader public health risks.