Harm Reduction Intervention for Opioid and Stimulant Use

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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the Culturally AdapTed Harm Reduction Intervention for opioid and stimulant use?

Research highlights the importance of culturally responsive treatments, which include traditional healing practices and family involvement, in improving outcomes for Indigenous communities dealing with opioid use disorders. These approaches have been shown to enhance engagement and recovery by addressing cultural needs and building trust. ^{1 2 3 4 5}

Is the Harm Reduction Intervention for Opioid and Stimulant Use generally safe for humans?

Harm reduction programs, including those using medications like methadone and buprenorphine, have been shown to be safe and effective in reducing the transmission of diseases like HIV among people who use drugs. These programs also offer additional services such as overdose education and naloxone distribution, which are considered safe and beneficial. ^{1 6 7 8 9}

How is the Culturally AdapTed Harm Reduction Intervention different from other treatments for opioid and stimulant use?

This treatment is unique because it incorporates cultural elements and traditional healing practices, focusing on the specific needs and contexts of different communities, such as American Indian/Alaska Native and Black communities, to improve engagement and recovery outcomes. ^{1 4 8 10 11}

What is the purpose of this trial?

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.

Research Team

Brittany Miller-Roenigk, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Psychostimulant Misuse Among American Indian, Alaskan Native, or Native Hawaiian College Students in the U.S. From 2015 to 2019. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of American Indian Health Service Training in Pain Management and Opioid Substance Use Disorder. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Opioid use in indigenous populations: indigenous perspectives and directions in culturally responsive care. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Clinician beliefs and practices related to increasing responsivity to the needs of Măori with alcohol and drug problems. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A scoping review of opioid harm reduction interventions for equity-deserving populations. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

"We want a living solution": views of harm reduction programs in black US Communities. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Buprenorphine Initiation in the Era of High-potency Synthetic Opioids: A Call for Community-based Participatory Research to Help Learning Health Systems Provide Precision Medicine for Opioid Use Disorder. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Mexican-American heroin addicts. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Future directions for medication assisted treatment for opioid use disorder with American Indian/Alaska Natives. [2023]