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

Trial Summary

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 data supports the effectiveness of the Native HEALTH treatment for reducing alcohol consumption?

The Native American Health Center's holistic system of care, which includes traditional healing practices and evidence-based methods, showed a decrease in substance use among participants, particularly in residential treatment settings. This suggests that culturally adapted treatments like Native HEALTH may be effective in reducing alcohol consumption. ^{1 2 3 4 5}

Is Native HEALTH safe for human use?

There is limited safety data available for Native HEALTH, especially if it is a natural health product. Herbal medicines often have underreported adverse events, so it's important to be cautious and consult with healthcare providers. ^{6 7 8 9 10}

How is the Native HEALTH treatment for alcohol consumption different from other treatments?

The Native HEALTH treatment is unique because it focuses on culturally specific approaches to address alcohol consumption among Native American populations, which are often overlooked in traditional treatments. This approach may include harm reduction strategies that are tailored to the cultural and community needs of Native Americans, making it distinct from standard treatments that do not consider these specific cultural factors. ^{5 11 12 13 14}

What is the purpose of this trial?

The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.

Research Team

Nicole H Weiss, Ph.D.

Principal Investigator

University of Rhode Island

Nichea S Spillane, Ph.D.

Principal Investigator

University of Rhode Island

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Holistic system of care: evidence of effectiveness. [2011]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Investigating Secondary Alcohol Outcomes in a Contingency Management Intervention among American Indian and Alaska Native Adults. [2023]

3. Finland pubmed.ncbi.nlm.nih.gov

Nutrition education for Native treatment centres. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Alcohol-related hospitalizations--Indian Health Service and tribal hospitals, United States, May 1992. [2008]

6. New Zealand 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Preventing Adverse Events at Research Facilities. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Adverse drug event reporting systems: a systematic review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Consumers of natural health products: natural-born pharmacovigilantes? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

"Montana gin": ingestion of commercial products containing denatured alcohol among native Americans. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Native American drinking: a neglected subject of study and research. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Harm reduction acceptability and feasibility in a North American indigenous reserve community. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Disparities in patterns of alcohol use among reservation-based and geographically dispersed American Indian populations. [2019]