HEALing Communities Study

July 10, 2026 updated by: Charles Knott, RTI International

HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New York
      • New York, New York, United States, 10027
        • Columbia University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Across all the HCS communities within each state, there must be a minimum of 150 opioid-related overdose fatalities (with at least 22 opioid-related overdose fatalities experienced by the rural communities) and a rate of at least 25 opioid-related overdose fatalities per 100,000 persons, based on 2016 data.
  • The community must express willingness to address in their response strategy the implementation of MOUD, overdose prevention training, and naloxone distribution across their community.
  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wave 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.
Other: Communities That HEAL
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.
Other Names:
  • CTH
Other: Wave 2 - Wait-list comparison
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Opioid Overdose Deaths
Time Frame: Months 19-30
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.
Months 19-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Naloxone Units Distributed in Communities
Time Frame: Months 19-30
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)
Months 19-30
Number of Individuals Receiving Buprenorphine Products That Are Approved by the Food and Drug Administration (FDA) for Treatment of OUD
Time Frame: Months 19-30
Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.
Months 19-30
Incidents of High-risk Opioid Prescribing
Time Frame: Months 19-30
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.
Months 19-30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event Incidence Per 1000 Community Members
Time Frame: 44 months

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.
44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

National Institute on Drug Abuse (NIDA)
Columbia University
Boston Medical Center
Ohio State University
University of Kentucky
Substance Abuse and Mental Health Services Administration (SAMHSA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38088
  • 1UM1DA049394 (U.S. NIH Grant/Contract)
  • 1UM1DA049415 (U.S. NIH Grant/Contract)
  • 1UM1DA049417 (U.S. NIH Grant/Contract)
  • 1UM1DA049412 (U.S. NIH Grant/Contract)
  • 1UM1DA049406 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The HEALing Communities Study period of performance ends September 2025. We expect data archival in April 2025.

IPD Sharing Access Criteria

The DCC will provide a statistical system file and limit administrative data to the study measures as outlined in the common data model (CDM). We will mask HCS geography and provide five flag variables (Research Site, Intervention Arm, Geography, Community, Time Frequency) in addition to the CDM outcomes. The DCC will suppress or statistically mask individual variables as required in each applicable data use agreement governing HCS administrative data release. The repository disseminates data to users based on its Access Policy Framework. HCS datasets are freely available to the public through the HCS thematic collection. Users download datasets and analyze them on their own computers. Access to data requires submission of username, institution, and analytic purpose and aim. There is no formal approval process initially planned by NIDA. Data users are expected to adhere to norms for responsible use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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