Communities That HEAL Intervention for Opioid Use Disorder

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

67 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose deaths by 40%.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+