Native HEALTH for Alcohol Consumption

(NativeHEALTH Trial)

Overseen By Nichea S Spillane, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rhode Island

Disqualifiers: Psychotic symptoms, High withdrawal scores

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on creating a new alcohol intervention program, called Native HEALTH, specifically for First Nation communities. The goal is to address alcohol use by developing a culturally relevant, trauma-informed program that considers historical trauma. Participants will either join the new program immediately or after a short wait. It suits First Nation members living in the partner community who have recently used alcohol and wish to reduce or stop. As an unphased trial, this study offers participants a unique opportunity to contribute to the development of a culturally tailored program that could significantly benefit their community.

Do I need to stop taking my current medications to join the trial?

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 this intervention is safe?

Research has shown that alcohol programs tailored to cultural needs are generally well-received and can help reduce alcohol use. Programs like Native HEALTH, which focus on reducing alcohol use among Indigenous communities, have been positively accepted.

Although specific safety data for Native HEALTH is not yet available, similar programs have produced good results without major side effects. This suggests that Native HEALTH could be safe for participants. However, as this program is new and still under evaluation, staying updated on any new safety information is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Native HEALTH treatment is unique because it is a cultural program specifically designed to reduce alcohol-related harm and improve quality of life among people in Kingsclear First Nation. Unlike conventional treatments, which may include medications or standard counseling, Native HEALTH incorporates cultural elements and community-specific approaches. Researchers are excited about this trial because it could offer a more personalized and culturally relevant way to address alcohol consumption, potentially leading to better engagement and outcomes for participants.

What evidence suggests that the Native HEALTH intervention could be effective for reducing alcohol use?

Research shows that both community and individual prevention methods can help reduce alcohol use in Indigenous communities. In this trial, participants will be randomized into different groups to assess the effectiveness of the Native HEALTH program. As a new initiative, the Native HEALTH program lacks extensive specific data on its effectiveness. However, it is designed to respect cultural traditions and address past traumas, which research suggests are important factors. Similar programs that consider cultural and historical backgrounds have successfully helped Indigenous people with alcohol issues. This suggests that Native HEALTH's approach might reduce alcohol use and improve quality of life. ^{1 3 6 7 8}

Who Is on the Research Team?

Nichea S Spillane, Ph.D.

Principal Investigator

University of Rhode Island

Nicole H Weiss, Ph.D.

Principal Investigator

University of Rhode Island

Are You a Good Fit for This Trial?

This trial is for adults over 18 who identify as First Nation members, live within the partner community, have used alcohol in the past week, and wish to reduce or stop their alcohol consumption. It's designed to help those dealing with psychological trauma and historical trauma.

Inclusion Criteria

Used alcohol in the past week

Self-identify as a First Nation member

Reside within the partner community

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Talking circles are used to develop the intervention/manual, exploring community strengths and resources.

Varies

Open Pilot Trial

Community members participate in the intervention and provide qualitative feedback to refine the manual.

Varies

Pilot Randomized Trial

Participants are randomized to either the intervention or wait-list control group to test feasibility and efficacy.

12 weeks

Follow-up

Participants are monitored for alcohol outcomes, historical losses, well-being, and community connectedness.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Native HEALTH

Trial Overview The study is testing 'Native HEALTH', a culturally tailored, trauma-informed intervention aimed at reducing alcohol use among First Nations individuals. The project involves building partnerships, developing the intervention through qualitative data, and assessing its acceptability and initial effectiveness against a waitlist control group in a pilot RCT (Randomized Controlled Trial).

How Is the Trial Designed?

Group I: Native HEALTH Condition Experimental Treatment 1 Intervention

Participants randomized to the Native HEALTH condition will complete the Native HEALTH intervention. This is a newly developed cultural program designed to reduce harm from alcohol use and improve quality of life among people in Kingsclear First Nation.

Group II: Wait-List Control Active Control 1 Intervention

Participants randomized to the wait-list control group will complete the Native HEALTH intervention after two months.

Who Is Running the Clinical Trial?

University of Rhode Island

Lead Sponsor

Trials

57

Recruited

22,400+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A systematic review of 108 adverse drug event (ADE) reporting systems revealed 1782 unique data fields, highlighting significant variability in how ADEs are reported, which complicates data comparison and aggregation across different systems.

Despite consistent reporting concepts, the lack of standardized terminology and the use of multiple drug and disease dictionaries hinder effective drug safety monitoring, suggesting a need for a common standardized dataset to improve ADE reporting and surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event reporting systems: a systematic review. Bailey, C., Peddie, D., Wickham, ME., et al.[2021]

The Canadian adverse event reporting system for herbal products is severely underreported, leading to a lack of safety data, which poses risks to consumers who often perceive these products as safe.

Health food store personnel in the Greater Toronto Area play a crucial role in reporting adverse reactions by collecting customer information during product returns, suggesting a potential pathway to improve safety monitoring and reporting for herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. Walji, R., Boon, H., Barnes, J., et al.[2021]

The study developed a method to extract comprehensive drug safety information from adverse event narratives using natural language processing (NLP), analyzing 3723 narratives from the Korea Adverse Event Reporting System (KAERS) between 2015 and 2019.

The KAERS-BERT model achieved high performance in extracting relevant data, improving data completeness by an average of 3.24% in structured fields, indicating that enhanced NLP techniques can significantly improve the quality of drug safety information in spontaneous reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques. Kim, S., Kang, T., Chung, TK., et al.[2023]

Project ENHANCE is a clinical trial involving 450 individuals with untreated alcohol use disorder (AUD) aimed at improving treatment engagement after hospital discharge through various intervention strategies, including brief negotiation interviews and medication initiation.

The study will assess the effectiveness of these interventions on AUD treatment engagement and alcohol use outcomes, while also considering the impact of racial and ethnic disparities, ultimately aiming to inform better hospital-based treatment approaches for diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting alcohol treatment engagement post-hospitalization with brief intervention, medications and CBT4CBT: protocol for a randomized clinical trial in a diverse patient population. Edelman, EJ., Rojas-Perez, OF., Nich, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39710495/

A randomized controlled trial of Native CHOICES The Native CHOICES intervention did not show evidence of effectiveness overall. However, exploratory analyses offer some evidence that the ...

2. withpower.com withpower.com/trial/early-phase-1-historical-trauma-6-2022-b4beb

Native HEALTH for Alcohol Consumption The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention.

3. sciencedirect.com sciencedirect.com/science/article/pii/S037687162500050X

A scoping review of harm reduction practices and ... We conducted a scoping review of primary studies regarding drug use harm reduction approaches among Indigenous communities in Australia, Canada, New Zealand, ...

4. niaaa.nih.gov niaaa.nih.gov/news-events/news-releases/study-finds-effective-interventions-prevent-alcohol-use-among-american-indian-and-rural-youth

Study finds effective interventions to prevent alcohol use ... Community-based and individual-level prevention strategies are effective ways to reduce alcohol use among American Indian and other youth ...

5. ireach.wsu.edu ireach.wsu.edu/projects/ncare-rp2-randomized-clinical-trial-of-harm-reduction-talking-circles-for-urban-american-indians-and-alaska-natives-with-alcohol-use-disorders/

Randomized Clinical Trial of Harm Reduction Talking Circles ... Alcohol-use disorders (AUDs) are a serious public health issue for urban American Indian and Alaska Native (AI/AN) people. They have twice the levels of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10248734/

Culturally tailored substance use interventions for ... Most interventions (n = 13; 72.22%) addressed the use of drugs and alcohol, with three (16.67%) interventions intended to specifically reduce only alcohol use ( ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acer.15521

A randomized controlled trial of Native CHOICES: Impact ... The Native CHOICES intervention was the first randomized controlled trial that aimed to reduce risk for alcohol-exposed pregnancy (AEP) in American Indian/ ...

8. niaaa.nih.gov niaaa.nih.gov/news-events/spectrum/volume-15-issue-3-fall-2023/incorporating-harm-reduction-alcohol-use-disorder-treatment-and-recovery

Incorporating Harm Reduction Into Alcohol Use Disorder ... Treatment and recovery strategies that reduce heavy alcohol consumption and alcohol-related consequences without complete abstinence can be effective.