An interventional study of Communities That HEAL and Wait-list control in Opioid Use Disorder (OUD), sponsored by RTI International. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by RTI International · Not applicable, Interventional, and Health services research
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%.
The HEALing Communities Study (HCS) is a multi-site, parallel group, cluster randomized wait-list controlled trial to test the impact of the Communities That HEAL (CTH) intervention, which is designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. 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. Communities receiving the intervention will be engaged to reach individuals who are at highest risk of overdose death (e.g., out of treatment, leaving jail) and: (1) expand access to and receipt of medication for opioid use disorder (MOUD) and behavioral treatment, (2) increase the number of individuals retained in treatment beyond 6 months, (3) reduce the risk of fatal overdose through expansion of overdose education and naloxone distribution, and (4) improve prescription opioid safety. In addition, the study will determine (1) the factors that contribute to or impede successful implementation of the CTH intervention, (2) the factors that contribute to or impede sustainment of CTH intervention, and (3) the incremental costs and cost effectiveness of the CTH intervention.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 67 is close to the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →RTI International is the lead sponsor of 81 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Communities That HEAL
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.
Other: Wait-list control
The Communities That HEAL (CTH) intervention is a community-engaged intervention designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. It includes 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.
Also known as: CTH
Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
Number of Opioid Overdose Deaths
Count of HCS community resident overdose deaths (i.e. deaths with an underlying cause of drug poisoning) where opioids were determined to be contributing (alone or in combination with other drugs) to the drug poisoning.
Time frame: Months 19-30
Number of Naloxone Units Distributed in Communities
Count of naloxone units distributed in the HCS communities during the measurement period as captured by the following submeasures: 1) count of naloxone units distributed by the state health agency (secondary data from state health agencies) and HCS study logs for naloxone distributed by the study and 2) the count of naloxone units sold by pharmacies (IQVIA pharmacy data)
Time frame: Months 19-30
Number of Individuals Receiving Buprenorphine Products That Are Approved by the Food and Drug Administration (FDA) for Treatment of OUD
Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.
Time frame: Months 19-30
Incidents of High-risk Opioid Prescribing
Count of individuals with one or more of the following during the twelve month study period (months 19-30), and not in a prior specified time window (3 months): risk of continued opioid use (new opioid episode lasting at least 31 days); initiating opioid treatment with extended-release or long-acting opioid; incident high dosage (average ≥ 90 mg morphine per day); and/or incident overlapping opioid and benzodiazepine for ≥ 30 days.
Time frame: Months 19-30
Adverse Event Incidence Per 1000 Community Members
The mean rate of emergency medical service (EMS) runs for a suspected opioid overdose per 1000 adults to assess potential adverse events and serious adverse events in the community. This is community level data of EMS runs (suspected opioid overdose events in the community areas), but not deaths. We had to use a surrogate measure (EMS runs: not the same as deaths, some may have died but others may have been saved) since the decedent/death certificate data had too long of a lag. AE Criterion: ORO (opioid-related overdose) rate for a single month increased \> 3 standard deviations (SDs) above the moving avg of the previous 3 months. SAE Criterion: ORO rate for a single month increased \> 4 SDs above the moving avg of the previous 3 months. The SD was determined from the monthly rates of the communities for the latest available 12-month period prior to the start of the intervention using a pooled estimate across communities. We did not monitor at the individual participant level.
Time frame: 44 months
| Milestone | Wave 1 - Intervention | Wave 2 - Wait-list Comparison |
|---|---|---|
| Started | NA | NA |
| Completed | NA | NA |
| Not completed | NA | NA |
Count of HCS community resident overdose deaths (i.e. deaths with an underlying cause of drug poisoning) where opioids were determined to be contributing (alone or in combination with other drugs) to the drug poisoning.
| Opioid-related overdose deaths | Wave 1 - Intervention | Wave 2 - Wait-list Comparison |
|---|---|---|
| Number of Opioid Overdose Deaths | 47.2 (41.8 to 53.2) | 51.7 (44.9 to 59.6) |
Count of naloxone units distributed in the HCS communities during the measurement period as captured by the following submeasures: 1) count of naloxone units distributed by the state health agency (secondary data from state health agencies) and HCS study logs for naloxone distributed by the study and 2) the count of naloxone units sold by pharmacies (IQVIA pharmacy data)
Results for this outcome have not been posted.
Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.
Results for this outcome have not been posted.
Count of individuals with one or more of the following during the twelve month study period (months 19-30), and not in a prior specified time window (3 months): risk of continued opioid use (new opioid episode lasting at least 31 days); initiating opioid treatment with extended-release or long-acting opioid; incident high dosage (average ≥ 90 mg morphine per day); and/or incident overlapping opioid and benzodiazepine for ≥ 30 days.
Results for this outcome have not been posted.
The mean rate of emergency medical service (EMS) runs for a suspected opioid overdose per 1000 adults to assess potential adverse events and serious adverse events in the community. This is community level data of EMS runs (suspected opioid overdose events in the community areas), but not deaths. We had to use a surrogate measure (EMS runs: not the same as deaths, some may have died but others may have been saved) since the decedent/death certificate data had too long of a lag. AE Criterion: ORO (opioid-related overdose) rate for a single month increased \> 3 standard deviations (SDs) above the moving avg of the previous 3 months. SAE Criterion: ORO rate for a single month increased \> 4 SDs above the moving avg of the previous 3 months. The SD was determined from the monthly rates of the communities for the latest available 12-month period prior to the start of the intervention using a pooled estimate across communities. We did not monitor at the individual participant level.
| Events per 1000 members | Wave 1 - Intervention | Wave 2 - Wait-list Comparison |
|---|---|---|
| Adverse Event Incidence Per 1000 Community Members | 0.0007659 | 0.0008748 |
Collected over 44 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wave 1 - Intervention | — | — | — |
| Wave 2 - Wait-list Comparison | — | — | — |
We randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention or a wait-list control, stratified according to state. To be eligible study communities had to have a high baseline rate of opioid-related overdose deaths (≥25 per 100,000 adults); and at least 30% had to be rural. Actual number of participants is unknown. Data for age, sex/gender, race, and region of enrollment at baseline was not collected in communities.
| Age, Customized(Participants) | Wave 1 - Intervention | Wave 2 - Wait-list Comparison | Total |
|---|
| Sex: Female, Male(Participants) | Wave 1 - Intervention | Wave 2 - Wait-list Comparison | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race (NIH/OMB)(Participants) | Wave 1 - Intervention | Wave 2 - Wait-list Comparison | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
| Region of Enrollment(Participants) | Wave 1 - Intervention | Wave 2 - Wait-list Comparison | Total |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We plan to make study methods, data, and results available to anyone interested in reducing the burden of the opioid crisis. The data sharing plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, the NIH Data Sharing Policy, and the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and the NIH Clinical Trial Registration and Results Information Submission rule. The data sharing plan will follow NIH requirements for sharing data via the creation of public-use data sets. A structured process will be used to evaluate the risk of re-identification based on guidance documents from the US DHHS and HIPAA. The risk of re-identification will also be quantitatively evaluated using accepted statistical methods. Study data deposited into a repository selected by NIDA, such as the National Addiction \& HIV Data Archive Program, will be de-identified or masked to minimize risks to study participant privacy.
Supporting information: Study protocol, Sap
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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RTI International