300 Participants Needed

Ceremony for Drug Addiction

MB
Overseen ByMiigis B Gonzalez, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Johns Hopkins Bloomberg School of Public Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how participating in a cultural ceremony, called Gii'igoshimong: Sitting With Your First Family, might reduce substance use and improve related health outcomes, such as depression and community support. Participants will be divided into two groups: one will join the ceremony immediately, while the other will wait before participating. This method helps researchers determine if the ceremony makes a difference over time. Suitable candidates for this trial include adults who identify as Ojibwe/Anishinaabe/Chippewa and have used substances in the past 30 days, but do not have a history of head injuries or Type 2 diabetes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Gii'Igoshimong ceremony is safe for participants?

Research on Gii'igoshimong, a ceremony used to treat drug addiction, remains in the early stages. Solid information about its safety in people is limited. However, since this trial is in Phase 2, it has already passed initial safety tests in earlier studies. Treatments in Phase 2 are generally expected to be safe based on early results, but they are still monitored closely for any side effects.

This treatment involves a cultural or spiritual practice, which typically carries fewer physical risks than medications or surgeries. It emphasizes mental and community support, which participants usually handle well. For those considering participation, these aspects might make it feel different from traditional drug treatments. Discuss any concerns with the research team or a healthcare provider.1

Why are researchers excited about this trial?

Researchers are excited about the "Gii'Igoshimong: Sitting With Your First Family" ceremony because it offers a unique, culturally-informed approach to drug addiction treatment. Unlike conventional treatments that often rely on medication or behavioral therapy, this method uses a ceremonial practice rooted in indigenous traditions to foster healing and connection. This approach not only targets addiction itself but also aims to address the underlying social and emotional factors in a holistic manner. By incorporating community and cultural identity into the recovery process, the ceremony has the potential to provide support and healing in a way that standard treatments may not.

What evidence suggests that the Gii'Igoshimong ceremony might be an effective treatment for drug addiction?

Research suggests that Gii'igoshimong, a ceremonial practice under study in this trial, might assist individuals with substance use issues. Studies have shown that traditional ceremonies can enhance positive factors like spirituality and community support, which are linked to better recovery. Participants in this trial will either take part in the Gii'igoshimong ceremony or be placed on a waitlist control. Those who participate in similar programs often feel more connected and supported, which can lead to reduced substance use and fewer related problems, such as depression. Although specific data on Gii'igoshimong is limited, the emphasis on community and spiritual involvement has shown promise in other contexts. This suggests potential benefits for participants in reducing substance use and improving well-being.123

Who Is on the Research Team?

MG

Migis Gonzalez, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with mental health issues or addiction, specifically drug addiction. Participants should be interested in exploring the impact of ceremony on substance use and related risk factors like depression, as well as protective factors such as spirituality and community support.

Inclusion Criteria

Self-identify as Ojibwe/Anishinaabe/Chippewa
I am 18 years old or older.
I do not have Type 2 Diabetes.
See 3 more

Exclusion Criteria

Currently pregnant
Does not self-identify as Ojibwe/Anishinaabe/Chippewa
Has Type 2 Diabetes
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments before randomization

1 week

Intervention

Participants in the intervention group participate in the Gii'igoshimong ceremony, which lasts up to four days

1 week

Post-Assessment

Participants complete post assessments at 1 month and 6 months after the intervention

6 months

Follow-up

Participants are monitored for substance use and other health outcomes after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Gii'Igoshimong: Sitting With Your First Family
Trial Overview The study examines whether a ceremonial intervention called Gii'Igoshimong can improve outcomes for substance use compared to a control group. It involves baseline assessments, random assignment to immediate participation or wait-list control, followed by reassessments at one month and six months.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CeremonyExperimental Treatment1 Intervention
Group II: Waitlist controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials
441
Recruited
2,157,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

NCT07075081 | Gii'Igoshimong: Sitting With Your First FamilyThe 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, ...
The Impact of Substance Use Disorders on Families and ...SUDs negatively affect emotional and behavioral patterns from the inception of the family, resulting in poor outcomes for the children and adults with SUDs.
Permanent Supportive Housing Overdose Prevention-2 StudyThis community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based ...
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