Culturally Tailored Recovery Programs for Substance Abuse

(IMANI U Trial)

Recruiting at 7 trial locations

Overseen By Luz S Ocasio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Informed consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

525 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment IMANI, Buprenorphine, Methadone, Suboxone, Telehealth MAT, Traditional MAT plus Referral and Linkage, Medication-Assisted Treatment, MAT for substance abuse?

Research shows that using telehealth for medication-assisted treatment (MAT) with buprenorphine for opioid use disorder leads to higher patient satisfaction, similar retention rates, and better access to treatment. This suggests that combining telehealth with MAT can be effective in treating substance abuse. ^{1 2 3 4 5}

Is the culturally tailored recovery program for substance abuse safe for humans?

Research shows that treatments like buprenorphine and methadone, often used in medication-assisted treatment (MAT) for opioid use disorder, are generally safe for humans. Studies have demonstrated that buprenorphine-naloxone (Suboxone) is safe and well-tolerated, with a good safety profile in diverse community settings. ^{4 5 6 7 8}

How is the IMANI treatment for substance abuse different from other treatments?

The IMANI treatment is unique because it combines culturally tailored recovery programs with medication-assisted treatment (MAT) like buprenorphine, methadone, and suboxone, and includes telehealth options. This approach integrates cultural healing practices, particularly for American Indian and Alaska Native communities, making it distinct from standard treatments by addressing cultural and community-specific needs. ^{3 9 10 11 12}

What is the purpose of this trial?

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.

Research Team

Ayana Jordan, PhD.

Principal Investigator

Yale University

Chyrell Bellamy, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for Black or Latinx individuals who want to reduce substance use and have been diagnosed with Alcohol Use Disorder or Opioid Use Disorder, using substances within the last month. They must be interested in treatment and agree to participate by signing a consent form.

Inclusion Criteria

Participants self-identify as Black or Latinx

I have been diagnosed with an alcohol or opioid use disorder and have used these substances in the last 30 days.

Participants are interested in reducing substance use

Exclusion Criteria

Participants who do not sign informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive education on Medication Assisted Treatment (MAT) during the initial weeks

4 weeks

Weekly group sessions

Treatment

Participants engage in the Imani weekly group program with either Traditional MAT services or church-based telehealth MAT option

24 weeks

Weekly group sessions

Follow-up

Participants are monitored for treatment adherence and substance use changes

12 months

Treatment Details

Interventions

• IMANI
• Telehealth MAT
• Traditional MAT plus Referral and Linkage

Trial Overview The study is testing culturally tailored recovery programs: IMANI, Telehealth MAT (Medication Assisted Treatment), and traditional MAT with extra support for accessing services. It aims to improve access and engagement in treatment among communities of color.

Participant Groups

Group I: IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM) Experimental Treatment 2 Interventions

Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as a church based telehealth Medication Assisted Treatment option. The church based telehealth MAT will consist of participants assigned to receive MAT from addiction treatment providers via telehealth. Telehealth sessions will be provided in the church.

Group II: IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage Experimental Treatment 2 Interventions

Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as Traditional MAT services with Referral and Linkage to services. Participants in this arm will be provided a list of referrals and links to community MAT providers. They will choose their providers.

Group III: IMANI BREAKTHROUGH Active Control 1 Intervention

Participants will participate in 24-week IMANI weekly groups

IMANI is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Buprenorphine for:

• Opioid use disorder

Approved in European Union as Methadone for:

• Opioid dependence

Approved in Canada as Suboxone for:

• Opioid addiction

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A study of 100 patients compared telepsychiatry and face-to-face buprenorphine medication-assisted treatment (MAT) for opioid use disorder, finding no significant differences in additional substance use or time to achieve 30 and 90 days of abstinence.

Both treatment methods showed similar retention rates at 90 and 365 days, suggesting that telepsychiatry is as effective as in-person treatment for managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. Zheng, W., Nickasch, M., Lander, L., et al.[2022]

Telehealth innovations in the treatment of opioid use disorder (OUD) with buprenorphine have been linked to higher patient satisfaction and increased access to treatment, based on a review of 69 studies.

The integration of telehealth has shown comparable retention rates and reduced healthcare costs, suggesting that these technologies could enhance the effectiveness of medication-assisted treatment for OUD, especially following relaxed federal guidelines during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Telehealth Solutions for Patients with Opioid Use Disorder Using Buprenorphine: A Scoping Review. Guillen, AG., Reddy, M., Saadat, S., et al.[2022]

A community-based opioid-dependence treatment program in a remote First Nations community, combining traditional healing strategies with buprenorphine-naloxone substitution therapy, led to significant improvements in community wellness, including a 61.1% reduction in police criminal charges and a 58.3% decrease in child protection cases after one year.

The program also resulted in increased school attendance by 33.3% and a remarkable 350.0% rise in seasonal influenza immunizations, highlighting the positive impact of integrating culturally relevant treatment approaches in addressing opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-wide measures of wellness in a remote First Nations community experiencing opioid dependence: evaluating outpatient buprenorphine-naloxone substitution therapy in the context of a First Nations healing program. Kanate, D., Folk, D., Cirone, S., et al.[2022]

A retrospective chart review of 177 patients in a rural Maryland drug treatment center showed that buprenorphine treatment delivered via telemedicine had high retention rates, with 98% at 1 week and 91% at 1 month.

After 3 months of treatment, 57% of patients remained engaged, and 86% of those had opioid-negative urine tests, indicating effective management of opioid use disorder through telemedicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. Weintraub, E., Greenblatt, AD., Chang, J., et al.[2019]

The nurse-led B-MAT clinic successfully increased access to buprenorphine-based treatment for opioid use disorder by 34% over seven months, demonstrating its effectiveness in a rural setting.

The program showed high retention rates, with all patients who completed 90 days of treatment remaining in the program, and no serious adverse events reported, indicating a safe and effective model for managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of office-based buprenorphine treatment for opioid use disorder. Carroll, E.[2023]

A cluster randomized controlled trial tested a mobile telephone-based contingency management (CM) system to improve adherence to supervised methadone treatment, showing high acceptability among patients and prescribers.

The study found that mobile CM effectively recorded medication adherence with 96% consistency compared to pharmacy records, indicating its potential for enhancing treatment compliance in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES). Metrebian, N., Carr, E., Goldsmith, K., et al.[2021]

During the COVID-19 pandemic, the Rhode Island Buprenorphine Hotline was established to provide access to buprenorphine treatment for individuals with opioid use disorder, utilizing audio-only telehealth to bypass the need for in-person evaluations.

This innovative approach, made possible by new regulatory guidance, allows for unobserved induction of buprenorphine, helping to connect vulnerable individuals to necessary treatment during a time of restricted access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovation During COVID-19: Improving Addiction Treatment Access. Samuels, EA., Clark, SA., Wunsch, C., et al.[2021]

Buprenorphine-naloxone (Suboxone) was found to be safe and well tolerated for short-term opioid detoxification in a study involving 234 opioid-dependent patients across twelve community-based treatment programs.

The treatment showed high medication compliance (81% of doses ingested) and successful induction, with 90% of patients reaching the target dose within three days, indicating its efficacy and practicality in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Amass, L., Ling, W., Freese, TE., et al.[2022]

The establishment of two Oxford House recovery homes on the Suquamish Tribal reservation has shown to be supportive of recovery for both American Indian and non-American Indian residents, indicating a successful adaptation of the model to tribal cultures.

The positive reception of these recovery homes may stem from their democratic structure, which aligns with tribal values, suggesting that culturally tailored recovery settings could be vital resources for addressing substance use disorders in American Indian communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A promising recovery housing model for American Indian communities. Jason, LA., Kassanits, J., Reilly, A., et al.[2020]

The study is testing a rapid access buprenorphine program in six Washington State communities, aiming to improve access for individuals with opioid use disorder (OUD) who face barriers to treatment, particularly those who are unhoused or using syringe services.

This Community-Based Medication-First model will evaluate effectiveness by comparing outcomes like arrests and health care utilization between participants in the program and a matched comparison group, providing insights into how to better serve those with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Community-Based Medication-First program for opioid use disorder: a hybrid implementation study protocol of a rapid access to buprenorphine program in Washington State. Banta-Green, CJ., Owens, MD., Williams, JR., et al.[2022]

A scoping review of 19 articles (13 empirical and 6 conceptual) highlighted that Tribal identity, culture, and experiences of discrimination are critical factors influencing substance use treatment outcomes for American Indian and Alaska Native (AI/AN) populations.

The review emphasizes the importance of culturally congruent research methods, such as community-based and Tribal participatory research, to improve treatment access and engagement for AI/AN individuals with substance use disorders, while also calling for more targeted strategies to enhance AI/AN participation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned and future directions: A scoping review of American Indian and Alaska Native participants in the National Drug Abuse Treatment Clinical Trials Network. Crouch, MC., Venner, KL., Wendt, DC., et al.[2023]

American Indian and Alaska Native communities are successfully using culture-specific methods, alongside modern best practices, to aid recovery from addiction to alcohol and drugs.

The Wellbriety Movement emphasizes the importance of cultural identity in recovery, promoting the idea that cultural heritage itself serves as a form of prevention against addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Native American healing experience. Coyhis, D., Simonelli, R.[2008]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. [2022]

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

Utilization of Telehealth Solutions for Patients with Opioid Use Disorder Using Buprenorphine: A Scoping Review. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Community-wide measures of wellness in a remote First Nations community experiencing opioid dependence: evaluating outpatient buprenorphine-naloxone substitution therapy in the context of a First Nations healing program. [2022]

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

Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. [2019]

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

Implementation of office-based buprenorphine treatment for opioid use disorder. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES). [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Innovation During COVID-19: Improving Addiction Treatment Access. [2021]

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

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]

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

A promising recovery housing model for American Indian communities. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The Community-Based Medication-First program for opioid use disorder: a hybrid implementation study protocol of a rapid access to buprenorphine program in Washington State. [2022]

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

Lessons learned and future directions: A scoping review of American Indian and Alaska Native participants in the National Drug Abuse Treatment Clinical Trials Network. [2023]

12. England pubmed.ncbi.nlm.nih.gov

The Native American healing experience. [2008]