NCT04617938

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

4.3 years

First QC Date

October 26, 2020

Results QC Date

March 24, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

American Indian/Alaska Native young adultsCultural interventionMotivational interviewing

Outcome Measures

Primary Outcomes (5)

  • Alcohol Use Past 3 Months

    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

  • Cannabis Use Past 3 Months

    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

  • Most Drinks in One Day During the Past Month

    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)

    3, 6, and 12 months post-baseline

  • Amount of Cannabis Used Per Day When Using

    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."

    3, 6, and 12 months post-baseline

  • Opioid Use Past 3 Months

    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 Outcomes (1)

  • Cultural Connectedness

    3, 6, and 12 months post-baseline

Study Arms (2)

TACUNA

EXPERIMENTAL

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.

Behavioral: TACUNA plus Wellness Circle

Opioid education

ACTIVE COMPARATOR

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.

Behavioral: Opioid Education Workshop

Interventions

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.

TACUNA

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.

Opioid education

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • If substance treatment need is indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

United American Indian Involvement, Inc

Los Angeles, California, 90017, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

RAND Corporation

Santa Monica, California, 90401, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Alcohol DrinkingMarijuana Use

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersMental Disorders

Limitations and Caveats

All AEs endorsed suicidal ideation in the PHQ. Those endorsing a 1 (several days) were reported to the IRB and PO quarterly. Those with a 2 or a 3 (more than half the days; nearly every day) were reported w/in 1 business day. Phase 1 (P1) informed Phase 2 (CT phase) via focus groups that included participants not part of Phase 2. Parents \& providers--all lacking eligibility in the CT--were also part of Phase 1. No NCT# for P1 as it was not an RCT. P1 was funded under a separate NIH award number.

Results Point of Contact

Title
Elizabeth D'Amico
Organization
RAND Corporation

Study Officials

  • Elizabeth D'Amico, PhD

    RAND

    PRINCIPAL INVESTIGATOR
  • Daniel Dickerson, DO, MPH

    UCLA Integrated Substance Abuse Programs

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 5, 2020

Study Start

November 23, 2020

Primary Completion

March 6, 2025

Study Completion

July 28, 2025

Last Updated

July 6, 2026

Results First Posted

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations