deltatrials
Completed NA INTERVENTIONAL 2-arm NCT04839978

Community Trial in the Cherokee Nation

Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents

Sponsor: Emory University

Conditions Opioid Abuse
Updated 14 times since 2021 Last updated: Feb 12, 2026 Started: Sep 29, 2021 Primary completion: May 17, 2024 Completion: Dec 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Opioid Abuse and is currently completed. Emory University leads this study, which shows 14 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs,...

The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.

Status Flow

~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Feb 2022 · 8 months · monthly snapshot~Feb 2022 – ~Feb 2023 · 12 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Apr 2024 · 12 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshot~Jul 2025 – ~Mar 2026 · 8 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot~Mar 2026 – present · 37 days · monthly snapshot

Change History

14 versions recorded
  1. Mar 2026 — Present [monthly]

    Completed NA

  2. Jan 2026 — Present [monthly]

    Completed NA

  3. Jul 2025 — Mar 2026 [monthly]

    Completed NA

  4. May 2025 — Jul 2025 [monthly]

    Completed NA

  5. Apr 2025 — May 2025 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

Show 9 earlier versions
  1. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting NA

  2. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

    Status: Enrolling By InvitationActive Not Recruiting

  3. Jul 2024 — Aug 2024 [monthly]

    Enrolling By Invitation NA

  4. Apr 2024 — Jul 2024 [monthly]

    Enrolling By Invitation NA

  5. Apr 2023 — Apr 2024 [monthly]

    Enrolling By Invitation NA

  6. Feb 2023 — Apr 2023 [monthly]

    Enrolling By Invitation NA

  7. Feb 2022 — Feb 2023 [monthly]

    Enrolling By Invitation NA

    Status: Not Yet RecruitingEnrolling By Invitation

  8. Jun 2021 — Feb 2022 [monthly]

    Not Yet Recruiting NA

    Status: Enrolling By InvitationNot Yet Recruiting

  9. May 2021 — Jun 2021 [monthly]

    Enrolling By Invitation NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Emory University
  • National Institute on Drug Abuse (NIDA)
Data source: Emory University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations