Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Gii'Igoshimong — Sitting With Your First Family ceremonial program for Ojibwe/Anishinaabe adults

Official title: The Protective Role of Ceremony Against Substance Use for American Indian Adults

Run by Johns Hopkins Bloomberg School of Public Health · NCT07075081 · Data updated 2026-11-12

This project will test whether taking part in the Gii'igoshimong ceremony helps Ojibwe/Anishinaabe adults who used substances in the past 30 days reduce substance use and improve related mental health and protective factors.

More Substance Use trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorJohns Hopkins Bloomberg School of Public Health
Academic / other
Locations1 site (Duluth, Minnesota)
StatusRecruiting
StartedSeptember 9, 2025
Main results expectedDecember 1, 2028
Study endsMay 31, 2029
Registry record updatedMarch 31, 2026
Trial IDNCT07075081 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Ojibwe/Anishinaabe adults age 18 or older who self-report using any substances in the past 30 days and who do not have pregnancy, a seizure disorder, Type 2 diabetes, or a history of head injury with loss of consciousness.

Probably not a fit

People who are under 18, do not self-identify as Ojibwe/Anishinaabe, have not used substances in the past 30 days, are pregnant, have a seizure disorder, Type 2 diabetes, or a history of head injury with loss of consciousness may not be eligible and are less likely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project uses a community-based participatory randomized wait-list control design enrolling about 300 Ojibwe/Anishinaabe adults who report substance use in the past 30 days. After baseline assessments, participants are randomized to attend an up-to four-day Gii'igoshimong ceremony immediately or to a wait-list control who attend after 1- and 6-month follow-ups, with all cohorts completing baseline, 1-month, and 6-month assessments. Outcomes include substance use behaviors, depressive symptoms, measures of spirituality and community support, and neurocognitive measures of self-relevant processing before and after ceremony. The study will also create and evaluate implementation strategies to support long-term community sustainment of the ceremonial practice.

Why it matters

Potential benefit: If successful, participating individuals could experience reduced substance use, fewer depressive symptoms, and stronger protective factors like spirituality and community support.

How similar studies have gone: Observational and community-based work suggests traditional ceremonial practices can protect against substance use, but randomized controlled trials testing these ceremonies are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Are 18 years of age or older,
* Self-identify as Ojibwe/Anishinaabe/Chippewa,
* Self-report using any kind of substances in the past 30 days,
* Have no history of head injury with loss of consciousness,
* Do not have a seizure disorder,
* Do not currently have Type 2 Diabetes,
* Are not currently pregnant

Exclusion Criteria:

* Younger than18 years of age
* Does not Self-identify as Ojibwe/Anishinaabe/Chippewa,
* Does not self-report using any kind of substances in the past 30 days,
* Has history of head injury with loss of consciousness,
* Has Type 2 Diabetes,
* Has a seizure disorder,
* Currently pregnant

Where it's running

  • Great Lakes Hub
    Duluth, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Migis Gonzalez, PhD — Johns Hopkins University
  • Study coordinator: Miigis B Gonzalez, PhD
  • Email: mgonza75@jhu.edu
  • Phone: 2183494603

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.