Recruiting
Phase 2

Gii'igoshimong

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT07075081

Conditions

Substance Use

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ceremony

Study Details

Brief summary:

The goal of this randomized wait-list control study is to understand the relationship between ceremony and substance use (SU), SU risk (e.g., SU severity, depressive symptoms) and protective factors (e.g., spirituality, community support). The main questions it aims to answer are:

  • Will adults enrolled in Gii'igoshimong show improved SU outcomes compared to those in control groups?
  • Will self-relevant processing networks activated during stimulus engagement increase from pre- to post- engagement in ceremony and at 6-month follow-up?

Researchers will compare adults that complete Gii'igoshimong with those that do not complete Gii'igoshimong to see if health outcomes are different.

After completing baseline assessments, participants will be randomized to complete Gii'igoshimong now (intervention) or after the participants have completed the 1 month and 6-month post assessments (waitlist control). All participants (intervention and waitlist control) within a cohort will complete 1 month and 6 month post assessments at the same time.

Conditions

Substance Use

Mental Health Issue

Study ID

NCT07075081

Start date

Sep 9, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ceremony

Completes baseline, ceremony, and post assessments (in that order).

no intervention: Waitlist control

Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement.

Interventions

Ceremony

Lifecourse ceremony led by Elders that used to be offered to everyone prior to colonization

Primary outcome measure

  • Days of substance use assessed by Timeline Follow Back (TLFB) [ Time Frame: baseline, 1 month, 6 month ]
  • Flourishing Scale [ Time Frame: baseline, 1 month, 6 month ]
  • Late Positive Potential (LPP) quantified as the average EEG response in microvolts to adjectives in the Self-referential Processing Task [ Time Frame: baseline, 1 month, 6 month ]

Central Contacts and Locations

Central contacts

Miigis B Gonzalez, PhD

2183494603mgonza75@jhu.edu

Locations

Great Lakes Hub

Recruiting

Duluth, Minnesota, United States, 55812

Contacts

Miigis Gonzalez, PhD

218-349-4603mgonza75@jhu.edu

Principal Investigator:

Miigis Gonzalez, PhD

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-03-31.