Opioid UseTACUNANCT04617938
TACUNA (Traditions and Connections for Urban Native Americans)
A study testing TACUNA plus Wellness Circle and Opioid Education Workshop in people with Opioid Use and Alcohol Drinking, run by RAND at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Alcohol Drinking, Marijuana Use
- What is being tested?
- TACUNA plus Wellness Circle and Opioid Education Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Nov 2020to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- If substance treatment need is indicated
Trial locations and contacts
3 sites in 1 country.
United States3 sites
United American Indian Involvement, Inc
Los Angeles, California, 90017
UCLA
Los Angeles, California, 90095
RAND Corporation
Santa Monica, California, 90401
About this study
Official title: Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
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.
Read the 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.
- Conditions
- Opioid Use, Alcohol Drinking, Marijuana Use
- Being tested
- TACUNA plus Wellness Circle, Opioid Education Workshop
- Keywords
- American Indian/Alaska Native young adults, Cultural intervention, Motivational interviewing
- Medical subject headings
- Alcohol Drinking, Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACUNA plus Wellness CircleBehavioural
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 WorkshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Opioid Education Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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."
Measured: 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.
Measured: 3, 6, and 12 months post-baseline
Secondary outcomes (1)
Cultural Connectedness
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
Measured: 3, 6, and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start23 Nov 2020
- Primary completion6 Mar 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Sacred Path Indigenous Wellness Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth D'Amico, PhD, Principal investigator, RANDDaniel Dickerson, DO, MPH, Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617938
- Sponsor's protocol ID
- 4UH3DA050235
- Acronym
- TACUNA
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2020
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Amico EJ, Dickerson DL, Rodriguez A, Klein DJ, Arvizu-Sanchez V, Schweigman K, Johnson C, Mann S, Kennedy DP, Holmes P, Palimaru AI, Brown R, Malika N. Virtual Culturally Grounded Interventions for Substance Use in Urban American Indian and Alaska Native Emerging Adults: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2627878. doi: 10.1001/jamanetworkopen.2026.27878.
PubMed 42579280Kuklinski 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.
PubMed 41085955D'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.
PubMed 37023284Kennedy 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.
PubMed 36180896D'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.
PubMed 34565444
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
- ClinicalTrials.gov ID
- NCT04617938
- Acronym / sponsor ID
- TACUNA / 4UH3DA050235
- Conditions
- Opioid Use, Alcohol Drinking, Marijuana Use
- Keywords
- American Indian/Alaska Native young adults, Cultural intervention, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Sacred Path Indigenous Wellness Center
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACUNA | Experimental | Behavioral: TACUNA plus Wellness CircleRandomized 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. |
| Opioid education | Active comparator | Behavioral: Opioid Education WorkshopRandomized 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- If substance treatment need is indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACUNA plus Wellness CircleTACUNA 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. | Behavioural | TACUNA |
| Opioid Education WorkshopThe 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. | Behavioural | Opioid education |
Primary outcome
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.
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.
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)
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."
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.
1 secondary outcome
Cultural Connectedness
Time frame: 3, 6, and 12 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42579280D'Amico EJ, Dickerson DL, Rodriguez A, Klein DJ, Arvizu-Sanchez V, Schweigman K, Johnson C, Mann S, Kennedy DP, Holmes P, Palimaru AI, Brown R, Malika N. Virtual Culturally Grounded Interventions for Substance Use in Urban American Indian and Alaska Native Emerging Adults: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2627878. doi: 10.1001/jamanetworkopen.2026.27878.
- Derived from this study: PubMed 41085955Kuklinski 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.
- Derived from this study: PubMed 37023284D'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.
- Derived from this study: PubMed 36180896Kennedy 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.
- Derived from this study: PubMed 34565444D'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.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth D'Amico, PhD principal investigator
RAND
Daniel Dickerson, DO, MPH principal investigator
UCLA Integrated Substance Abuse Programs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACUNA plus Wellness Circle and Opioid Education Workshop in people with Opioid Use and Alcohol Drinking, run by RAND at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Past 3 Months (time frame: 3, 6, and 12 months post-baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617938, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.