TACUNA Program for Opioid Use Disorder

(TACUNA Trial)

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

541 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the TACUNA treatment for opioid use disorder?

The TACUNA program is designed specifically for urban American Indian/Alaska Native young adults, integrating culturally appropriate strategies to address opioid use. While direct effectiveness data for TACUNA is not provided, the program builds on previous work with these communities, suggesting it may be beneficial by incorporating cultural elements into prevention efforts. ^{1 2 3 4 5}

Is the TACUNA Program for Opioid Use Disorder safe for humans?

The TACUNA Program, which includes culturally appropriate workshops for urban Native American emerging adults, has been developed with community input, but there is no specific safety data available from the research articles provided. ^{1 2 4 6 7}

How is the TACUNA treatment for opioid use disorder different from other treatments?

The TACUNA treatment is unique because it combines a specific program with Wellness Circle or Wellness Gathering, which may offer a more holistic and community-focused approach compared to traditional treatments that often rely solely on medication or standard counseling. ^{3 4 5 8 9}

Research Team

Daniel Dickerson, DO, MPH

Principal Investigator

UCLA Integrated Substance Abuse Programs

Elizabeth D'Amico, PhD

Principal Investigator

RAND

Eligibility Criteria

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

I am between 18 and 25 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Integrating traditional practices and social network visualization to prevent substance use: study protocol for a randomized controlled trial among urban Native American emerging adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Traditions and Connections for Urban Native Americans (TACUNA): Utilizing community-based input to develop an opioid prevention intervention for urban American Indian/Alaska Native emerging adults. [2022]

3. Ireland 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The use of auricular acupuncture in opioid use disorder: A systematic literature review. [2022]

5. United States 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. [2023]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Identifying behaviours for survival and wellness among people who use methamphetamine with opioids in British Columbia: a qualitative study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Pregnant women in treatment for opioid use disorder: Material hardships and psychosocial factors. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Challenges in recruiting and training drug treatment patients as peer outreach workers: a perspective from the field. [2015]