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Completed

NCT Number: NCT04617938

TACUNA (Traditions and Connections for Urban Native Americans)

This study responds to Request For Application-DA-19-035, HEAL (Helping End Addiction Long Term) initiative: Preventing OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally centered intervention to address opioid use among urban AI/AN emerging adults in California. The primary goal of this study is to compare AI/AN emerging adults who receive TACUNA plus a Wellness Circle (WC) to those AI/AN emerging adults who receive an opioid education workshop on outcomes (e.g., opioid misuse and alcohol and other drug use) over a period of 12 months. TACUNA will be a motivational interviewing group intervention that incorporates traditional practices and discussion of how to cultivate healthy social networks and cultural worlds. The Wellness gathering will be for emerging adults and people in their social network, and will focus on how social networks and cultural connectedness influence healthy behaviors. Opioid education will focus on discussion of opioid misuse within the AI/AN urban community and ways to reduce use in a culturally appropriate manner. Investigators expect those who receive TACUNA + WG will report less opioid and AOD (alcohol and other drug) use frequency, fewer consequences, less time spent around peers who use opioids and AOD, and less perceived prevalence of peer use compared to opioid education over a period of 12 months. Also, investigators will evaluate the intervention's effects on secondary outcomes of social networks and cultural connectedness. Survey data is collected at baseline, 3-months, 6-months and 12-months. Longitudinal analyses will compare intervention participant and control participants on primary and secondary outcomes.

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Key information

Conditions

Opioid Use Alcohol Drinking Behavior Drinking Behavior Marijuana Use Mental Disorders Substance-Related Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACUNA plus Wellness Circle

Behavioral

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.

Opioid Education Workshop

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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. Most Drinks in One Day During the Past Month

    Time frame: 3, 6, and 12 months post-baseline

    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)

  4. Amount of Cannabis Used Per Day When Using

    Time frame: 3, 6, and 12 months post-baseline

    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."

  5. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Sacred Path Indigenous Wellness Center
  • University of California, Los Angeles

Registry information

Official study title

Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California

Acronym: TACUNA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2020
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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