Opioid Use Disorder (OUD)NCT04111939
HEALing Communities Study
A study testing Communities That HEAL in people with Opioid Use Disorder (OUD), run by RTI International at 4 sites in United States.
Trial summary
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%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Use Disorder (OUD)
- What is being tested?
- Communities That HEAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Oct 2019to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Communities that did not meet the aforementioned inclusion criteria were excluded from the HCS.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Medical Center
Boston, Massachusetts, 02118
Ohio State University
Columbus, Ohio, 43210
University of Kentucky
Lexington, Kentucky, 40508
Columbia University
New York, New York, 10027
About this study
Official title: 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%.
Read the 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.
- Conditions
- Opioid Use Disorder (OUD)
- Being tested
- Communities That HEAL, Wait-list control
- Keywords
- opioid, Opioid Use Disorder (OUD), overdose, addiction, Naloxone, Buprenorphine, methadone, evidence-based practices, community engagement
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communities That HEALOther
Also called CTH
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.
Wait-list controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 - Intervention | Experimental | 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. Receives: Other: Communities That HEAL |
| Wave 2 - Wait-list comparison | Other | 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. Receives: Other: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Months 19-30
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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.
Measured: Months 19-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start23 Oct 2019
- Primary completion31 Dec 2023
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Columbia University, Ohio State University, University of Kentucky, National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Charles Knott, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111939
- Sponsor's protocol ID
- 38088
- Other IDs
- 1UM1DA049394, 1UM1DA049415, 1UM1DA049417, 1UM1DA049412, 1UM1DA049406
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2019
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Goddard-Eckrich D, Chahine RA, Chandler R, Villani J, Gilbert L, Salsberry P, Dsouza N, Choi S, Walsh SL, Lancaster KE, Oga E, Mack N, D'Costa L, Chatterjee A, Walley AY, Lea CH 3rd, Kim E, Calver K, Huang TT, Hunt T, Mack S, Brown JL, David JL, Ezell J, Freisthler B, LaRochelle M, Lyons MS, Mack A, Slavova S, Mack SR, El-Bassel N, Dasgupta A, Pavelka C, Feaster DJ. Differences in trajectories of fatal and nonfatal opioid overdose by race and ethnicity in the HEALing Communities Study from 2018 to 2023. J Subst Use Addict Treat. 2026 Oct 7:210127. doi: 10.1016/j.josat.2026.210127. Online ahead of print.
PubMed 42843524Rubi S, Ingram T, Brown JL, Sprunger J, Matherny P, Lyons MS, Winhusen TJ. Implementation of mobile medical units for naloxone distribution and MOUD linkage in Ohio's HEALing Communities Study: a community case study. Front Public Health. 2026 Jul 29;14:1883800. doi: 10.3389/fpubh.2026.1883800. eCollection 2026.
PubMed 42591172Chassler D, Hayes A, McClay C, Macone A, Colon M, Powers K, Alvarez P, Laudate A, Langis G, Tirado T, Battaglia T, Martinez LS. Community Advisory Board Members Speak Out: Insights From an Opioid Overdose Study. Health Expect. 2026 Aug;29(4):e70794. doi: 10.1111/hex.70794.
PubMed 42542979Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the costs and reach of transportation services to reduce barriers to opioid use disorder (OUD) treatment: evidence from the Kentucky HEALing Communities Study. Addict Sci Clin Pract. 2026 Jul 20. doi: 10.1186/s13722-026-00702-1. Online ahead of print.
PubMed 42477841Goetz M, Andrews-Higgins S, Davis OA, Back-Haddix S, Fanucchi L, Lofwall MR, Walsh SL, Knudsen HK. Staff perceptions of care navigators in medication for opioid use disorder treatment settings. Subst Abuse Treat Prev Policy. 2026 Jun 27. doi: 10.1186/s13011-026-00743-4. Online ahead of print.
PubMed 42365341Goddard-Eckrich D, Chahine RA, Glasgow L, Oga E, Miles J, Holloway J, Hall ME, Bagley SM, Kim E, Davis A, Chassler D, D'souza N, Mack S, Davis J, Harness J, Lea CH 3rd, Bridden C, Herron N, Larimore E, Calver K, Salsberry P. Community coalition's diversity and targeted overdose prevention strategies designed to reach special populations. Harm Reduct J. 2026 May 18. doi: 10.1186/s12954-026-01458-2. Online ahead of print.
PubMed 42151985Walker DM, Aldrich AM, Chen S, Jadovich E, Goetz M, Andrews-Higgins S, Walley AY, Knudsen HK, Huerta TR, Hunt T, Drainoni ML. The role of external and internal context on adoption and implementation of evidence-based practices: a serial case study qualitative analysis of top performers in the HEALing Communities Study. Implement Sci Commun. 2026 Apr 25;7(1):115. doi: 10.1186/s43058-026-00952-9.
PubMed 42035176Dsouza N, Russo M, Goddard-Eckrich D, Hernandez D, Sabounchi N, Lounsbury D, Fowler P, Benjamin SN, Campbell ANC, Dasgupta A, El-Bassel N, Gilbert L. Community-level perceptions of housing services for people with opioid use disorder: a qualitative analysis of community stakeholders in the HEALing communities study. Subst Abuse Treat Prev Policy. 2026 Apr 15;21(1):27. doi: 10.1186/s13011-025-00683-5.
PubMed 41987187Wu E, Balise R, Katz B, Harris D, Bullard M, Fareed N, Larochelle M, Villani J. Building Public Health Data Dashboards: Tutorial Playbook. JMIR Public Health Surveill. 2026 Apr 9;12:e83157. doi: 10.2196/83157.
PubMed 41955547Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the Costs and Reach of Transportation Services to Reduce Barriers to Opioid Use Disorder (OUD) Treatment: Evidence from the Kentucky HEALing Communities Study. Res Sq [Preprint]. 2025 Nov 20:rs.3.rs-7999770. doi: 10.21203/rs.3.rs-7999770/v1.
PubMed 41333386Luster J, Reynolds J, Chahine R, Lewis N, Stein MD, Lefebvre RC, D'Costa L, Asman K, Stephens K, Dsouza N, Slater MD. A Cross-Sectional Study of Acceptability and Influence of HEALing Communities Study Communications Campaign Messaging Among Community Members in Four U.S. States. Am J Health Promot. 2026 Jul;40(6):654-662. doi: 10.1177/08901171251398985. Epub 2025 Nov 14.
PubMed 41237130Chatterjee A, Chase RP, Chahine RA, Davis J, Dsouza N, Ellison S, Bagley SM, Fisher T, Glasgow L, Harris MTH, Huang TT, Holloway J, Lounsbury DW, Oga E, Asman K, Roberts SM, Sabounchi N, Surratt HL, Lines LM, Stadler HW, Taylor JL, Davis A. Local level of social inequity moderates implementation of evidence-based practices tailored to minoritized populations to reduce opioid overdose deaths. J Subst Use Addict Treat. 2026 Jan;180:209828. doi: 10.1016/j.josat.2025.209828. Epub 2025 Oct 30.
PubMed 41175975Li JM, Gruss D, Hunt T, David J, Rodgers E, El-Bassel N, Schackman BR, Starbird LE. Cost of implementing evidence-based practices to reduce opioid overdose fatalities in New York State communities. Addict Sci Clin Pract. 2025 Oct 1;20(1):77. doi: 10.1186/s13722-025-00606-6.
PubMed 41034965Katz R, Fisher T, Singer-Clark T, Soares Iii W, Carpenter J, Schuessler N, Stadler H, Sahovey A, McAlearney AS, Samet JH, Chatterjee A. Creation of a telehealth addiction consultation service at a rural hospital: a case study. Addict Sci Clin Pract. 2025 Sep 26;20(1):76. doi: 10.1186/s13722-025-00596-5.
PubMed 41013782Hall ME, Glasgow L, Holloway J, Chahine RA, Davis J, Harris MTH, Knudsen HK, Neufeld JL, Oga E, Lounsbury DW, Sabounchi N, Davis A, Smith M, Chase RP, Ellison SA, Harness J, Surratt HL, Walsh SL, Nakayima PJ, Chandler R. Reach of Community-Selected Strategies to Reduce Opioid-Related Overdose Deaths in the HEALing Communities Study. Subst Use Misuse. 2026;61(2):200-208. doi: 10.1080/10826084.2025.2549496. Epub 2025 Sep 2.
PubMed 40892527
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis
- ClinicalTrials.gov ID
- NCT04111939
- Acronym / sponsor ID
- 38088
- Conditions
- Opioid Use Disorder (OUD)
- Keywords
- opioid, Opioid Use Disorder (OUD), overdose, addiction, Naloxone, Buprenorphine, methadone, evidence-based practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Boston Medical Center, Columbia University, Ohio State University, University of Kentucky, National Institute on Drug Abuse (NIDA), Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wave 1 - Intervention | Experimental | Other: Communities That HEALCommunities 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. |
| Wave 2 - Wait-list comparison | Other | Other: Wait-list controlCommunities 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Communities that did not meet the aforementioned inclusion criteria were excluded from the HCS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communities That HEALAlso: CTHThe 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 | Wave 1 - Intervention |
| Wait-list controlCommunities 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. | Other | Wave 2 - Wait-list comparison |
Primary outcome
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.
3 secondary outcomes
Number of Naloxone Units Distributed in Communities
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
Time frame: Months 19-30
Incidents of High-risk Opioid Prescribing
Time frame: Months 19-30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42843524Goddard-Eckrich D, Chahine RA, Chandler R, Villani J, Gilbert L, Salsberry P, Dsouza N, Choi S, Walsh SL, Lancaster KE, Oga E, Mack N, D'Costa L, Chatterjee A, Walley AY, Lea CH 3rd, Kim E, Calver K, Huang TT, Hunt T, Mack S, Brown JL, David JL, Ezell J, Freisthler B, LaRochelle M, Lyons MS, Mack A, Slavova S, Mack SR, El-Bassel N, Dasgupta A, Pavelka C, Feaster DJ. Differences in trajectories of fatal and nonfatal opioid overdose by race and ethnicity in the HEALing Communities Study from 2018 to 2023. J Subst Use Addict Treat. 2026 Oct 7:210127. doi: 10.1016/j.josat.2026.210127. Online ahead of print.
- Derived from this study: PubMed 42591172Rubi S, Ingram T, Brown JL, Sprunger J, Matherny P, Lyons MS, Winhusen TJ. Implementation of mobile medical units for naloxone distribution and MOUD linkage in Ohio's HEALing Communities Study: a community case study. Front Public Health. 2026 Jul 29;14:1883800. doi: 10.3389/fpubh.2026.1883800. eCollection 2026.
- Derived from this study: PubMed 42542979Chassler D, Hayes A, McClay C, Macone A, Colon M, Powers K, Alvarez P, Laudate A, Langis G, Tirado T, Battaglia T, Martinez LS. Community Advisory Board Members Speak Out: Insights From an Opioid Overdose Study. Health Expect. 2026 Aug;29(4):e70794. doi: 10.1111/hex.70794.
- Derived from this study: PubMed 42477841Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the costs and reach of transportation services to reduce barriers to opioid use disorder (OUD) treatment: evidence from the Kentucky HEALing Communities Study. Addict Sci Clin Pract. 2026 Jul 20. doi: 10.1186/s13722-026-00702-1. Online ahead of print.
- Derived from this study: PubMed 42365341Goetz M, Andrews-Higgins S, Davis OA, Back-Haddix S, Fanucchi L, Lofwall MR, Walsh SL, Knudsen HK. Staff perceptions of care navigators in medication for opioid use disorder treatment settings. Subst Abuse Treat Prev Policy. 2026 Jun 27. doi: 10.1186/s13011-026-00743-4. Online ahead of print.
- Derived from this study: PubMed 42151985Goddard-Eckrich D, Chahine RA, Glasgow L, Oga E, Miles J, Holloway J, Hall ME, Bagley SM, Kim E, Davis A, Chassler D, D'souza N, Mack S, Davis J, Harness J, Lea CH 3rd, Bridden C, Herron N, Larimore E, Calver K, Salsberry P. Community coalition's diversity and targeted overdose prevention strategies designed to reach special populations. Harm Reduct J. 2026 May 18. doi: 10.1186/s12954-026-01458-2. Online ahead of print.
- Derived from this study: PubMed 42035176Walker DM, Aldrich AM, Chen S, Jadovich E, Goetz M, Andrews-Higgins S, Walley AY, Knudsen HK, Huerta TR, Hunt T, Drainoni ML. The role of external and internal context on adoption and implementation of evidence-based practices: a serial case study qualitative analysis of top performers in the HEALing Communities Study. Implement Sci Commun. 2026 Apr 25;7(1):115. doi: 10.1186/s43058-026-00952-9.
- Derived from this study: PubMed 41987187Dsouza N, Russo M, Goddard-Eckrich D, Hernandez D, Sabounchi N, Lounsbury D, Fowler P, Benjamin SN, Campbell ANC, Dasgupta A, El-Bassel N, Gilbert L. Community-level perceptions of housing services for people with opioid use disorder: a qualitative analysis of community stakeholders in the HEALing communities study. Subst Abuse Treat Prev Policy. 2026 Apr 15;21(1):27. doi: 10.1186/s13011-025-00683-5.
- Derived from this study: PubMed 41955547Wu E, Balise R, Katz B, Harris D, Bullard M, Fareed N, Larochelle M, Villani J. Building Public Health Data Dashboards: Tutorial Playbook. JMIR Public Health Surveill. 2026 Apr 9;12:e83157. doi: 10.2196/83157.
- Derived from this study: PubMed 41333386Speer DD, Bush JL, Ekanayake DL, Nakayima J, Goetz MM, Miles J, Larimore E, Knudsen HK, Walsh SL, McCollister KE. Analysis of the Costs and Reach of Transportation Services to Reduce Barriers to Opioid Use Disorder (OUD) Treatment: Evidence from the Kentucky HEALing Communities Study. Res Sq [Preprint]. 2025 Nov 20:rs.3.rs-7999770. doi: 10.21203/rs.3.rs-7999770/v1.
- Derived from this study: PubMed 41237130Luster J, Reynolds J, Chahine R, Lewis N, Stein MD, Lefebvre RC, D'Costa L, Asman K, Stephens K, Dsouza N, Slater MD. A Cross-Sectional Study of Acceptability and Influence of HEALing Communities Study Communications Campaign Messaging Among Community Members in Four U.S. States. Am J Health Promot. 2026 Jul;40(6):654-662. doi: 10.1177/08901171251398985. Epub 2025 Nov 14.
- Derived from this study: PubMed 41175975Chatterjee A, Chase RP, Chahine RA, Davis J, Dsouza N, Ellison S, Bagley SM, Fisher T, Glasgow L, Harris MTH, Huang TT, Holloway J, Lounsbury DW, Oga E, Asman K, Roberts SM, Sabounchi N, Surratt HL, Lines LM, Stadler HW, Taylor JL, Davis A. Local level of social inequity moderates implementation of evidence-based practices tailored to minoritized populations to reduce opioid overdose deaths. J Subst Use Addict Treat. 2026 Jan;180:209828. doi: 10.1016/j.josat.2025.209828. Epub 2025 Oct 30.
- Individual participant dataSharing planned: 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.
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Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communities That HEAL in people with Opioid Use Disorder (OUD), run by RTI International at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Opioid Overdose Deaths (time frame: Months 19-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111939, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.