Communities That HEAL Intervention for Opioid Use Disorder

Not currently recruiting at 3 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

Disqualifiers: Non-qualifying communities

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on reducing opioid overdose deaths by testing a community-based program called Communities That HEAL. It aims to lower overdose deaths by 40% in 67 communities severely affected by the opioid crisis. The trial will compare two groups: one receiving the program immediately and another on a wait-list. The program involves engaging locals, using proven methods, and spreading awareness about opioid issues. Communities in Kentucky, Ohio, Massachusetts, or New York with a significant number of overdose fatalities and a willingness to address opioid problems are well-suited for this trial. As an unphased trial, this study offers communities a unique opportunity to actively participate in pioneering efforts to combat the opioid crisis.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Communities That HEAL intervention is safe for reducing opioid overdose deaths?

Research has shown that the Communities That HEAL (CTH) program has been tested in states like Kentucky, Massachusetts, New York, and Ohio, which have been heavily affected by opioid issues. These studies examined how effectively communities could reduce opioid overdose deaths through community involvement, proven methods, and communication efforts.

The studies did not identify any direct side effects or negative events from the CTH program itself. This is likely because the program employs community strategies rather than introducing a new drug or medical procedure. It focuses on helping communities use known and safe methods to address opioid problems.

In simpler terms, because the program uses established techniques, it is considered safe for communities to use. Previous research has not shown any harm from the program itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Communities That HEAL (CTH) intervention for opioid use disorder because it takes a holistic approach to addressing the crisis at the community level. Unlike standard treatments, which often focus on individual therapies or medications like methadone or buprenorphine, CTH engages entire communities by helping local stakeholders implement evidence-based practices. This intervention also includes a robust communications campaign to build public demand for these practices. By empowering communities with a tailored strategy, researchers hope to create sustainable change in how opioid use disorder is managed and ultimately reduce overdose rates.

What evidence suggests that the Communities That HEAL intervention is effective for opioid use disorder?

Studies have shown that the Communities That HEAL program effectively reduces problems related to opioid use in communities. Research indicates a 15% drop in non-fatal opioid overdoses, leading to fewer emergency room visits and hospital stays. Additionally, the program has been linked to lower death rates from opioid and certain stimulant drugs. In this trial, some communities will receive the Communities That HEAL intervention immediately, while others will join a wait-list control group, receiving the intervention later. Participants in the program also reported a decrease in negative attitudes towards those receiving treatment for opioid use disorder. These results suggest the program could help communities manage and reduce opioid overdose deaths. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

The HEALing Communities Study is for communities in Kentucky, Ohio, Massachusetts, or New York that are heavily impacted by opioid overdoses. Eligible communities must have a high rate of opioid-related deaths and be willing to implement strategies like medication-assisted treatment (MOUD), overdose training, and naloxone distribution.

Inclusion Criteria

The community must express willingness to develop partnerships across health care, behavioral health, and justice settings for evidence-based practices to address opioid misuse, OUD, and overdoses

The community must be located in one of the four participating states: Kentucky, Ohio, Massachusetts, or New York

At least 30% of the communities selected within each state must be rural

Exclusion Criteria

Communities that did not meet the aforementioned inclusion criteria were excluded from the HCS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Communities in Wave 1 receive the CTH intervention, including community engagement, evidence-based practice selection, and a communications campaign

30 months

Wait-list Comparison

Communities in Wave 2 continue usual care before receiving the CTH intervention

30 months

Follow-up

Participants are monitored for outcomes such as opioid overdose deaths and naloxone distribution

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Communities That HEAL
• Wait-list control

Trial Overview This study tests the 'Communities That HEAL' intervention aimed at reducing opioid overdose deaths by 40%. Some communities will start the program right away while others will wait to begin. The effectiveness of this community-wide approach on preventing deaths from opioids is being compared.

How Is the Trial Designed?

Group I: Wave 2 - Wait-list comparison Experimental Treatment 1 Intervention

Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.

Group II: Wave 1 - Intervention Experimental Treatment 1 Intervention

Communities in Wave 1 will receive the CTH intervention during the first 30 months of the trial. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence-based practices to address overdose and opioid use disorder.

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials

201

Recruited

942,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Trials

31

Recruited

23,300+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825142

Communities That HEAL Intervention and Mortality ... This randomized clinical trial examines the effectiveness of a coordinated intervention to lower drug overdose deaths at the community level ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39432308/

Communities That HEAL Intervention and Mortality Including ... In this clinical trial of the CTH intervention, death rates involving an opioid and noncocaine psychostimulant were reduced; total deaths did not differ ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395925000970

The effectiveness of the communities that HEAL ... These findings suggest the intervention reduced NFOO ED visits and hospitalizations. The lack of effect modifications suggests that the intervention may be ...

4. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00037-1/fulltext

Effects of the Communities that Heal (CTH) intervention on ... Stakeholders in communities receiving the CTH intervention reported a significant decrease in perceived community stigma toward people treated ...

5. sig.columbia.edu sig.columbia.edu/news/healing-communities-study-finds-15-decrease-non-fatal-opioid-overdose-intervention-communities

HEALing Communities Study Finds 15% Decrease in Non ... This 15% reduction in non-fatal opioid overdoses translates to an estimated 40 averted overdoses across the study's 67 communities, and an ...

6. heal.nih.gov heal.nih.gov/research/research-to-practice/healing-communities

HEALing Communities Study Launched in 2019, the study took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000598

Do communities implementing the CTH intervention have ... This report aims to determine whether communities randomized to the Communities That HEAL (CTH) intervention have significantly different rates of prescription ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2401177

Community-Based Cluster-Randomized Trial to Reduce ... HCS investigators examined the potential of the community-engaged, data-driven CTH intervention to reduce the rate of opioid-related overdose ...