TACUNA Program for Opioid Use Disorder

(TACUNA Trial)

No longer recruiting at 2 trial locations

Overseen By Michael Woodward

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: Substance treatment need

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new ways to help American Indian and Alaska Native young adults reduce opioid and other substance use. Researchers are comparing two approaches: one group will participate in TACUNA workshops with a Wellness Circle, focusing on cultural practices and building healthy social networks, while the other group will attend an opioid education workshop. The trial seeks to determine if the TACUNA approach is more effective in reducing substance use and improving social connections. This study suits young adults aged 18-25 who identify as AI/AN and are not currently in need of substance treatment. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could shape future substance use interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for guidance.

What prior data suggests that the TACUNA program and its components are safe for participants?

Studies have shown that the TACUNA program, which includes workshops and a Wellness Circle, aims to reduce opioid and other substance use among American Indian and Alaska Native (AI/AN) young adults. This program helps participants make healthy choices by incorporating traditional practices and fostering social connections.

While specific data on TACUNA's safety is not available, it employs motivational interviewing, a well-accepted counseling method. Motivational interviewing supports individuals in making positive changes without causing harm. Reports have not indicated any negative effects from this approach, suggesting it is safe for participants.

In summary, TACUNA is designed to assist young adults with opioid use disorder, using methods known to be safe and supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TACUNA Program for Opioid Use Disorder because it offers a culturally tailored approach that integrates traditional practices and social support, which is not typically emphasized in standard treatments like medication-assisted therapy or cognitive behavioral therapy. The TACUNA program combines virtual workshops focusing on behavioral, physical, and spiritual domains with a Wellness Circle that emphasizes healthy social networks and traditional practices. This holistic approach is designed to resonate specifically with American Indian and Alaska Native youth, aiming to empower them to make healthy choices regarding opioid and alcohol use. By focusing on cultural connection and community support, TACUNA offers a unique avenue that could enhance the effectiveness of traditional opioid use disorder treatments.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that the TACUNA program, which participants in this trial may receive, includes workshops and a Wellness Circle and may help reduce opioid misuse among urban American Indian and Alaska Native youth. Early results suggest that young people in TACUNA use opioids and alcohol less often and face fewer problems related to substance use. This program also promotes healthier friendships and stronger cultural ties, supporting positive behavioral changes. The combination of motivational interviewing and traditional practices appears promising in reducing substance use in this community. While more research is needed, early signs indicate that TACUNA could effectively address opioid use disorder in urban Native youth. ^{2 3 4 5 6}

Who Is on the Research Team?

Daniel Dickerson, DO, MPH

Principal Investigator

UCLA Integrated Substance Abuse Programs

Elizabeth D'Amico, PhD

Principal Investigator

RAND

Are You a Good Fit for This Trial?

This trial is for American Indian/Alaska Native individuals aged 18-25 who do not require substance treatment. It aims to help urban AI/AN young adults in California reduce opioid, alcohol, and other drug use through culturally centered interventions.

Inclusion Criteria

You identify yourself as American Indian or Alaska Native.

You cannot have a current need for drug or alcohol addiction treatment.

Exclusion Criteria

I need treatment for substance use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend TACUNA workshops and Wellness Circles or opioid education workshops

12 months

3 virtual TACUNA workshops and 1 Wellness Circle for experimental group; 1 virtual opioid education workshop for control group

Follow-up

Participants are monitored for changes in opioid and AOD use, social networks, and cultural connectedness

12 months

Survey data collected at baseline, 3-months, 6-months, and 12-months

What Are the Treatments Tested in This Trial?

Interventions

• Opioid Education Workshop
• TACUNA plus Wellness Circle
• TACUNA plus Wellness Gathering

Trial Overview The study compares two groups: one receiving TACUNA plus a Wellness Circle focusing on traditional practices and social networks, and the other attending an opioid education workshop tailored to the AI/AN community's needs.

How Is the Trial Designed?

Group I: TACUNA Experimental Treatment 1 Intervention

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.

Group II: Opioid education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

Sacred Path Indigenous Wellness Center

Collaborator

Trials

2

Recruited

730+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

The NADA auricular acupuncture protocol, while not effective in reducing immediate opiate cravings or withdrawal symptoms, may help improve treatment retention and lower methadone dosages in individuals with opioid use disorder (OUD).

This systematic review analyzed four randomized trials and suggests that incorporating the NADA protocol as a complementary treatment could enhance recovery efforts and potentially reduce the overall health risks associated with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of auricular acupuncture in opioid use disorder: A systematic literature review. Baker, TE., Chang, G.[2022]

The low-threshold group-based MOUD program at a federally qualified health center in Philadelphia effectively increased patient access and retention through its person-centered harm reduction approach and integration into primary care.

Challenges included varying staff acceptance of harm reduction principles and the need to manage clinic workflow, highlighting the importance of understanding both strengths and challenges for similar programs in other clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a place that gives me hope": A qualitative evaluation of a buprenorphine-naloxone group visit program in an urban federally qualified health center. Lai, S., Li, E., Silverio, A., et al.[2022]

The pilot program aimed at reducing readmission rates for opioid use disorder (OUD) after inpatient detoxification showed a decrease in readmission rates in the treatment facilities, but these changes were not statistically significant when compared to control facilities, indicating that more effective strategies are needed.

Despite the implementation of individualized treatment plans, there was no significant improvement in the use of lower levels of care or medications for OUD, suggesting that while the program may have had some impact, it did not fully address the ongoing treatment needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of 90-day inpatient detoxification readmission for opioid use disorder by a community-based life-changing individualized medically assisted evidence-based treatment (C.L.I.M.B.) program: A quasi-experimental study. Luo, Z., Roychoudhury, C., Pompos, WS., et al.[2023]

The Community Reinforcement Approach and Family Training for Treatment Retention (CRAFT-T) showed a moderate effect on improving treatment retention for opioid-dependent adults, particularly when the concerned significant other was a parent, where it had a significant impact (p<0.01).

CRAFT-T also significantly reduced opioid and other drug use among participants, indicating its potential efficacy as a treatment intervention for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot clinical trial to evaluate the efficacy of Community Reinforcement and Family Training for Treatment Retention (CRAFT-T) for improving outcomes for patients completing opioid detoxification. Brigham, GS., Slesnick, N., Winhusen, TM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04617938

TACUNA (Traditions and Connections for Urban Native ... Investigators expect those who receive TACUNA + WG will report less opioid and AOD (alcohol and other drug) use frequency, fewer consequences, less time spent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9187599/

Traditions and Connections for Urban Native Americans ... A new opioid prevention intervention for urban AI/AN emerging adults ages 18–25. TACUNA comprises three 2-hour virtual workshops.

3. withpower.com withpower.com/trial/phase-alcohol-drinking-10-2020-5d4bd

TACUNA Program for Opioid Use Disorder · Info for Participants 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 ...

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT04617938

TACUNA (Traditions and Connections for Urban Native ... 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 ...

5. researchgate.net researchgate.net/publication/359558001_Traditions_and_Connections_for_Urban_Native_Americans_TACUNA_Utilizing_community-based_input_to_develop_an_opioid_prevention_intervention_for_urban_American_IndianAlaska_Native_emerging_adults

Traditions and Connections for Urban Native Americans ... The study team conducted this study to develop Traditions and Connections for Urban Native Americans (TACUNA), a new opioid prevention ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474938/

Integrating traditional practices and social network ... TACUNA comprises three workshops and a wellness circle. The ... Information about opioid use disorder and medications for OUD treatment.