Substance UsePhase 2NCT07075081
Gii'Igoshimong: Sitting With Your First Family
A Phase 2 study testing Ceremony in people with Substance Use and Mental Health Issue, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Mental Health Issue
- What is being tested?
- Ceremony
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Great Lakes Hub
Duluth, Minnesota, 55812
Miigis Gonzalez, PhD, 218-349-4603, mgonza75@jhu.edu
Miigis Gonzalez, PhD
About this study
Official title: The Protective Role of Ceremony Against Substance Use for American Indian Adults
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?
Read more
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.
Read the detailed description
This project seeks to engage American Indian (AI) adults with community and spiritual worldviews via ceremony (Gii'igoshimong). In doing so, the investigators will attempt to buffer the effects of historical trauma, personal trauma, and lifelong risk factors for substance use, thereby improving substance use behaviors, related outcomes, and overall health.
The Community-Based Participatory Research will enroll AI adults (Aim 2 \& 3) to implement a randomized controlled trial (N = 300 target adults) with a wait-list design respectful of cultural norms of inclusion. The investigators will evaluate the relationship between ceremony and adult substance use and identify multilevel factors (i.e., psychosocial, neurocognitive) through which traditional practices convey protection against substance use. The investigators will assess and develop a menu of implementation strategies (Sub-aim 2) to support community priority of long-term sustainment of the ceremonial practice.
TRIAL (Aim 2):
An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial with N = 300 participants. Once enrolled and consented into the trial, participants will complete baseline assessments. Once baseline assessments are complete, participants will be randomized into either intervention (ceremony) or control (wait-list). Intervention is an up to four-day ceremony, that was traditionally offered to every Anishinaabe person when the Anishinaabe person reached puberty. Today, this ceremony is being revived, and yet, accessibility to this ceremonial opportunity remains low. Ceremony will be described in more detail below. Both intervention and control arms will complete 1 month post and 6-month post assessments. Control arm participants will be offered the ceremony after completion of the 6-month assessments.
POST-CEREMONY FOCUS GROUP DISCUSSIONS (FGD) (Sub-aim 2) The investigators will conduct focus group discussions (FGDs) with ceremony treatment arm participants at six months post-baseline (6 total FGDs) to get participant feedback on the ceremony, thoughts on the effects of participation, and suggestions for strengthening implementation.
KEY INFORMANT INTERVIEWS (KII) (Sub-aim 2) The investigators will conduct key informant interviews (KIIs) with ceremony leaders at mid-trial to get feedback on ceremony implementation and suggestions for improving implementation moving forward.
IMPLEMENTATION MAPPING FGD (Sub-aim 2) The investigators will conduct two sequential FGDs with ceremony leaders and other community leaders. In the first implementation mapping FGD, the investigators will present the results of the KIIs/FGDs that were done during the trial, outlining what the investigators think are the key issues/barriers to implementation of the ceremony in the community moving forward. The investigators will then facilitate a group discussion where the investigators try to reach consensus on those issues. After FGD 1, the investigators will (independently) try to come up with some strategies that the tribe could use to support implementation in the long-term. In FGD 2, the investigators will present these back to the same group and get feedback/try to seek consensus
ELECTROENCEPHALOGRAPHY (EEG) (Aim 3) The investigators will examine the neurocognitive effects of Gii'igoshimong ceremony and associated stimuli relevant to reducing substance use. This study will establish the measurement validity of electroencephalography/event related potential (EEG/ERP) indicators of self-referential processing and an indicator of cultural identification, a critical step in the science of delineating the potential of cultural factors as disease modifying processes. EEG assessments will be a required activity of the Trial. These assessments will be completed at the same time as Trial survey assessments.
- Conditions
- Substance Use, Mental Health Issue
- Being tested
- Ceremony
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeremonyOther
Lifecourse ceremony led by Elders that used to be offered to everyone prior to colonization
| Study group | Role | What they receive |
|---|---|---|
| Ceremony | Experimental | Completes baseline, ceremony, and post assessments (in that order). Receives: Other: Ceremony |
| Waitlist control | No intervention | Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of substance use assessed by Timeline Follow Back (TLFB)
Days of substance use
Measured: baseline, 1 month, 6 month
Flourishing Scale
Score range: 8-40; lower score means higher Positive mental health
Measured: 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
Larger magnitude LPP (i.e., higher microvolts) indicates larger attention engagement
Measured: baseline, 1 month, 6 month
Secondary outcomes (4)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Score range: 0-27; lower score is indicative of lower risk
Measured: baseline, 1 month, 6 month
Center for Epidemiologic Studies Depression Scale (CESDR-10)
Scale range: 0-40; lower score = lower depression
Measured: baseline, 1 month, 6 month
General Anxiety Disorder-7 (GAD-7)
Scale range: 7-28; lower scores indicates lower anxiety
Measured: baseline, 1 month, 6 month
Self-rated (physical, mental, spiritual) health
Adapted from the Composite International Diagnostic Interview; Score ranges 1-5 for physical health; Score ranges 1-5 for mental health; Score ranges 1-5 for spiritual health; lower score is better
Measured: baseline, 1 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start9 Sep 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Migis Gonzalez, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075081
- Sponsor's protocol ID
- IRB00030209
- Other IDs
- R01DA057904
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez MB, Johnson AZ, Martin LA, Naawakwe, Fish J, Sevillano L, Walls ML, Staples LO. Planting the seed: using research as a tool to revitalize puberty ceremonies in Anishinaabe communities. Qual Res J. 2024 Dec 4;24(5):473-490. doi: 10.1108/QRJ-03-2024-0072. Epub 2024 Oct 10.
PubMed 40191601
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Role of Ceremony Against Substance Use for American Indian Adults
- ClinicalTrials.gov ID
- NCT07075081
- Acronym / sponsor ID
- IRB00030209
- Conditions
- Substance Use, Mental Health Issue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project seeks to engage American Indian (AI) adults with community and spiritual worldviews via ceremony (Gii'igoshimong). In doing so, the investigators will attempt to buffer the effects of historical trauma, personal trauma, and lifelong risk factors for substance use, thereby improving substance use behaviors, related outcomes, and overall health.
The Community-Based Participatory Research will enroll AI adults (Aim 2 \& 3) to implement a randomized controlled trial (N = 300 target adults) with a wait-list design respectful of cultural norms of inclusion. The investigators will evaluate the relationship between ceremony and adult substance use and identify multilevel factors (i.e., psychosocial, neurocognitive) through which traditional practices convey protection against substance use. The investigators will assess and develop a menu of implementation strategies (Sub-aim 2) to support community priority of long-term sustainment of the ceremonial practice.
TRIAL (Aim 2):
An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial with N = 300 participants. Once enrolled and consented into the trial, participants will complete baseline assessments. Once baseline assessments are complete, participants will be randomized into either intervention (ceremony) or control (wait-list). Intervention is an up to four-day ceremony, that was traditionally offered to every Anishinaabe person when the Anishinaabe person reached puberty. Today, this ceremony is being revived, and yet, accessibility to this ceremonial opportunity remains low. Ceremony will be described in more detail below. Both intervention and control arms will complete 1 month post and 6-month post assessments. Control arm participants will be offered the ceremony after completion of the 6-month assessments.
POST-CEREMONY FOCUS GROUP DISCUSSIONS (FGD) (Sub-aim 2) The investigators will conduct focus group discussions (FGDs) with ceremony treatment arm participants at six months post-baseline (6 total FGDs) to get participant feedback on the ceremony, thoughts on the effects of participation, and suggestions for strengthening implementation.
KEY INFORMANT INTERVIEWS (KII) (Sub-aim 2) The investigators will conduct key informant interviews (KIIs) with ceremony leaders at mid-trial to get feedback on ceremony implementation and suggestions for improving implementation moving forward.
IMPLEMENTATION MAPPING FGD (Sub-aim 2) The investigators will conduct two sequential FGDs with ceremony leaders and other community leaders. In the first implementation mapping FGD, the investigators will present the results of the KIIs/FGDs that were done during the trial, outlining what the investigators think are the key issues/barriers to implementation of the ceremony in the community moving forward. The investigators will then facilitate a group discussion where the investigators try to reach consensus on those issues. After FGD 1, the investigators will (independently) try to come up with some strategies that the tribe could use to support implementation in the long-term. In FGD 2, the investigators will present these back to the same group and get feedback/try to seek consensus
ELECTROENCEPHALOGRAPHY (EEG) (Aim 3) The investigators will examine the neurocognitive effects of Gii'igoshimong ceremony and associated stimuli relevant to reducing substance use. This study will establish the measurement validity of electroencephalography/event related potential (EEG/ERP) indicators of self-referential processing and an indicator of cultural identification, a critical step in the science of delineating the potential of cultural factors as disease modifying processes. EEG assessments will be a required activity of the Trial. These assessments will be completed at the same time as Trial survey assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An effectiveness trial where Gii'igoshimong will be tested in a randomized waitlist control trial
| Arm | Type | Receives |
|---|---|---|
| Ceremony | Experimental | Other: CeremonyCompletes baseline, ceremony, and post assessments (in that order). |
| Waitlist control | No intervention | –Completes baseline, post assessments, and is offered ceremony (in that order) but is not required to complete ceremony for study involvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| CeremonyLifecourse ceremony led by Elders that used to be offered to everyone prior to colonization | Other | Ceremony |
Primary outcome
Days of substance use assessed by Timeline Follow Back (TLFB)
Time frame: baseline, 1 month, 6 month
Days of substance use
Flourishing Scale
Time frame: baseline, 1 month, 6 month
Score range: 8-40; lower score means higher Positive mental health
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
Larger magnitude LPP (i.e., higher microvolts) indicates larger attention engagement
4 secondary outcomes
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: baseline, 1 month, 6 month
Center for Epidemiologic Studies Depression Scale (CESDR-10)
Time frame: baseline, 1 month, 6 month
General Anxiety Disorder-7 (GAD-7)
Time frame: baseline, 1 month, 6 month
Self-rated (physical, mental, spiritual) health
Time frame: baseline, 1 month, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 40191601Gonzalez MB, Johnson AZ, Martin LA, Naawakwe, Fish J, Sevillano L, Walls ML, Staples LO. Planting the seed: using research as a tool to revitalize puberty ceremonies in Anishinaabe communities. Qual Res J. 2024 Dec 4;24(5):473-490. doi: 10.1108/QRJ-03-2024-0072. Epub 2024 Oct 10.
- Individual participant dataSharing planned: No
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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.
Migis Gonzalez, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceremony in people with Substance Use and Mental Health Issue, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miigis B Gonzalez, PhD (2183494603, mgonza75@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of substance use assessed by Timeline Follow Back (TLFB) (time frame: baseline, 1 month, 6 month). The study lists 3 primary outcomes in all. 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 NCT07075081, which also lists 1 linked publication.
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 31 Mar 2026.