- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617938
TACUNA (Traditions and Connections for Urban Native Americans) (TACUNA)
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data from 2015 show that American Indians/Alaska Natives (AI/ANs) have the highest rates of diagnosis for opioid use disorders (OUD) and deaths from drug overdose. Misuse of prescription opioids, defined here as taking opioid medications in a manner or dose other than prescribed or for hedonic effects, and the use of heroin, have emerged as major public health concerns in the United States. Of particular concern is the prevalence of opioid use among emerging adults (ages 18-25) as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development.
Unique risk factors may predispose urban AI/AN young adults to use opioids, alcohol or other drugs. For example, experiences of acculturative stress directly and indirectly associated with historical trauma experienced by AI/ANs throughout U.S. history result in poor health outcomes. One U.S. law that has been postulated to contribute to various health disparities among urban AI/ANs is the Relocation Act of 1956. This Act financed the relocation of individual AIs and AI families to job training centers in designated U.S. cities. Rather than establishing economic stability, large numbers of AIs who moved to urban areas became unemployed, homeless, and disconnected from their community-based support networks. This relocation appears to have contributed to an inter-generational effect whereby successive generations of urban AIs and ANs continue to experience various health-related disparities. Our work with urban AI/AN adolescents highlighted that many experience stress related to identity in the form of both subtle (e.g., being asked whether one is a "real" Indian) and overt (e.g., being called a racist name like Squaw or Red Skin) discrimination. Programming that incorporates traditional practices, promotes community involvement, and encourages healthy notions of AI/AN identity may increase well-being and healthy behaviors by addressing sources of stress linked to cultural identity, stigma, and community connections. However, few evidence-based programs that integrate these cultural elements have been developed, implemented, and evaluated with urban AI/AN using a strong research design. The current study substantially extends work with AI/AN emerging adults by adapting and testing an integrated culturally appropriate MI and social network intervention to address opioid and other AOD (alcohol and other drug) misuse at both the individual and community level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA
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Los Angeles, California, United States, 90017
- United American Indian Involvement, Inc
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Santa Monica, California, United States, 90401
- RAND Corporation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- must self-identify as American Indian/Alaska Native (AI/AN)
- be in the age range of 18-25
- not be in need of substance treatment
Exclusion Criteria:
- If substance treatment need is indicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Opioid education
Randomized participants will attend 1 virtual opioid education workshop, focused on behavioral and physical domains, and designed to guide AI/AN youth to make healthy choices surrounding opioid and AOD use.
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The virtual opioid education workshop draws from prevention and education materials supplied and recommended by the National AI/AN Technology and Transfer Center, which is funded by SAMHSA.
Materials are culturally relevant educational packages addressing opioid use through recorded webinars, toolkits, and other resources.
|
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Experimental: TACUNA
Randomized participants will attend 3 virtual TACUNA workshops, focused on behavioral, physical, and spiritual domains, and designed to guide AI/AN youth to make healthy choices surrounding opioid and AOD use.
They will also attend a Wellness Circle, focused on healthy social networks and engaging in traditional practices.
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TACUNA provides three virtual workshops (one hour each) that use motivational interviewing and a virtual Wellness Circle (WC).
The workshops combine a 30-minute discussion of opioid, alcohol and marijuana use, and social networks with another 30 minutes focused on three different traditional practices (one per workshop).
TACUNA was adapted from our three-session workshop, MICUNAY (Motivational Interviewing and Culture for Urban Native American Youth) protocol, which was developed and tested for urban AI/AN adolescents and from focus groups conducted in Year 1.
For the Wellness Circle, youth will have members of their social network virtually attend these once-a-month gatherings.
The WC will bring people together to celebrate health and wellness and tradition.
The WC will focus on the importance of social networks in making healthy choices, and provide discussion on the role that AOD use and engagement in traditional practices among members of their social networks affect their choices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Use Past 3 Months
Time Frame: 3, 6, and 12 months post-baseline
|
Survey asks number of times had "At least one drink of alcohol."
Response was on a scale with options 0=none, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20-30 times, and 7=31+ times.
Responses were translated to actual number of times by taking the midpoints of intervals, e.g.
response 3 ("3-5 times") coded as 4 times.
To be conservative values were rounded down when the midpoint was not an integer, e.g.
response 4 ("6-9 times") coded as 7 times.
Response 7 ("31+ times") was coded as 31 times.
|
3, 6, and 12 months post-baseline
|
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Cannabis Use Past 3 Months
Time Frame: 3, 6, and 12 months post-baseline
|
Survey asks how many times participant used "Marijuana (cannabis, pot, weed, hash)."
Response was on a scale with options 0=none, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20-30 times, and 7=31+ times.
Responses were translated to actual number of times by taking the midpoints of intervals, e.g.
response 3 ("3-5 times") coded as 4 times.
To be conservative values were rounded down when the midpoint was not an integer, e.g.
response 4 ("6-9 times") coded as 7 times.
Response 7 ("31+ times") was coded as 31 times.
|
3, 6, and 12 months post-baseline
|
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Most Drinks in One Day During the Past Month
Time Frame: 3, 6, and 12 months post-baseline
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If participant reports any drinks in past month, survey asks "What is the largest number of drinks you had on any day in the PAST MONTH (30 DAYS)?" Response options range from 1 (a few sips) to 17 (15 or more drinks)
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3, 6, and 12 months post-baseline
|
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Amount of Cannabis Used Per Day When Using
Time Frame: 3, 6, and 12 months post-baseline
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Participants reporting lifetime marijuana use were asked "On the days you use marijuana, about how much marijuana flower/bud do you personally consume?" with response options ranging from 1="less than 0.25g" to 10="more than 5g."
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3, 6, and 12 months post-baseline
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|
Opioid Use Past 3 Months
Time Frame: 3, 6, and 12 months post-baseline
|
Measure Description: Survey asks number of times used "Prescription opioid."
Response was on a scale with options 0=none, 1=1 time, 2=2 times, 3=3-5 times, 4=6-9 times, 5=10-19 times, 6=20-30 times, and 7=31+ times.
Responses were translated to actual number of times by taking the midpoints of intervals, e.g.
response 3 ("3-5 times") coded as 4 times.
To be conservative values were rounded down when the midpoint was not an integer, e.g.
response 4 ("6-9 times") coded as 7 times.
Response 7 ("31+ times") was coded as 31 times.
|
3, 6, and 12 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cultural Connectedness
Time Frame: 3, 6, and 12 months post-baseline
|
Measured using the Sense of Community Index-2.
Mean of 24 items about AI/AN communities (example: "I get important needs of mine met because I am part of this community") with response options ranging from 0=not at all to 3=completely, with higher values indicating a greater sense of community
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3, 6, and 12 months post-baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth D'Amico, PhD, RAND
- Principal Investigator: Daniel Dickerson, DO, MPH, UCLA Integrated Substance Abuse Programs
Publications and helpful links
General Publications
- Kennedy DP, D'Amico EJ, Brown RA, Palimaru AI, Dickerson DL, Johnson CL, Lopez A. Feasibility and acceptability of incorporating social network visualizations into a culturally centered motivational network intervention to prevent substance use among urban Native American emerging adults: a qualitative study. Addict Sci Clin Pract. 2022 Sep 30;17(1):53. doi: 10.1186/s13722-022-00334-1.
- D'Amico EJ, Dickerson DL, Rodriguez A, Brown RA, Kennedy DP, Palimaru AI, Johnson C, Smart R, Klein DJ, Parker J, McDonald K, Woodward MJ, Gudgell N. Integrating traditional practices and social network visualization to prevent substance use: study protocol for a randomized controlled trial among urban Native American emerging adults. Addict Sci Clin Pract. 2021 Sep 26;16(1):56. doi: 10.1186/s13722-021-00265-3.
- D'Amico EJ, Kennedy DP, Malika N, Klein DJ, Brown RA, Rodriguez A, Johnson CL, Schweigman K, Arvizu-Sanchez V, Etz K, Dickerson DL. Risk and protective factors of social networks on alcohol, cannabis, and opioid use among urban American Indian/Alaska Native emerging adults. Psychol Addict Behav. 2023 Aug;37(5):657-669. doi: 10.1037/adb0000918. Epub 2023 Apr 6.
- Kuklinski MR, Gibbons BJ, Bowser DM, McCollister KE, Smart R, Dunlap LJ, Shenkar E, Bonar EE, Boomer T, Campbell M, Fiellin LE, Hutton DW, Rao V, Saldana L, Su K, Walton MA, Yilmazer T. Investing in Interventions to Prevent Opioid Use Disorder in Adolescents and Young Adults: Start-up Costs from NIDA's HEAL Prevention Initiative. Prev Sci. 2025 Nov;26(7):1045-1055. doi: 10.1007/s11121-025-01835-6. Epub 2025 Oct 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4UH3DA050235 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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