Culturally Tailored Recovery Programs for Substance Abuse
(IMANI U Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Overseen ByAyana Jordan, PhD.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Disqualifiers: Informed consent
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
45678How 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.
39101112Eligibility 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
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)Experimental Treatment2 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 LinkageExperimental Treatment2 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 BREAKTHROUGHActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Aery Baptist ChurchBridgeport, CT
Principe of Peace ChurchBridgeport, CT
Blackwell Memorial AME ChurchHartford, CT
Varick Memorial AME ChurchNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. [2022]To retrospectively review clinic records to assess the difference between face-to-face and telepsychiatry buprenorphine medication-assisted treatment (MAT) programs for the treatment of opioid use disorder on 3 outcomes: additional substance use, average time to achieve 30 and 90 consecutive days of abstinence, and treatment retention rates at 90 and 365 days.
Utilization of Telehealth Solutions for Patients with Opioid Use Disorder Using Buprenorphine: A Scoping Review. [2022]Background: A scoping review was conducted to examine the breadth of evidence related to telehealth innovations being utilized in the treatment of opioid use disorder (OUD) with buprenorphine and its effect on patient outcomes and health care delivery. Materials and Methods: The authors systematically searched seven databases and websites for peer-reviewed and gray literature related to telehealth solutions for buprenorphine treatment published between 2008 and March 18, 2021. Two reviewers screened titles and abstracts for articles that met the inclusion criteria, according to the scoping review study protocol. The authors included studies if they specifically examined telehealth interventions aimed at improving access to and usage of buprenorphine for OUD. Results: After screening 371 records, the authors selected 69 for full review. These studies examined the effect of telehealth on patient satisfaction, treatment retention rates, and buprenorphine accessibility and adherence. Conclusion: According to the reviewed literature, incorporation of telehealth technology with medication-assisted treatment for OUD is associated with higher patient satisfaction, comparable rates of retention, an overall reduction in health care costs, and an increase in both access to and usage of buprenorphine. This has been made possible through the expansion of telehealth technologies and a substantial push toward relaxed federal guidelines, both of which were quickly escalated in response to the COVID-19 pandemic. Future research is needed to fully quantify the effect of these factors; however, the results appear promising thus far and should urge policymakers to consider making these temporary policy changes permanent.
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]To document the development of unique opioid-dependence treatment in remote communities that combines First Nations healing strategies and substitution therapy with buprenorphine-naloxone.
Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. [2019]The opioid epidemic in the United States has resulted in a public health emergency. Medication-assisted treatment (MAT) with methadone and buprenorphine are evidence-based treatments for opioid use disorder. However, numerous barriers hinder access to treatment in rural areas. The use of telemedicine to deliver psychiatric services is demonstrated to be safe and effective; however, limited data exist on the novel application of telemedicine in the delivery of MAT. This report describes the results of a retrospective chart review of 177 patients in a rural drug treatment center that were treated with buprenorphine through telemedicine.
Implementation of office-based buprenorphine treatment for opioid use disorder. [2023]Buprenorphine-based medication-assisted treatment (B-MAT) is a powerful, concrete intervention that can be provided by nurse practitioners (NPs) to reduce opioid-related overdoses in patients with opioid use disorder (OUD). However, multiple barriers exist to provide and access this therapy.
Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES). [2021]Prescription methadone or buprenorphine enables people with opioid use disorder to stop heroin use safely while avoiding withdrawal. To ensure methadone is taken as prescribed and to prevent diversion onto the illicit market, people starting methadone take their daily dose under a pharmacist's supervision. Many patients miss their daily methadone dose risking withdrawal, craving for heroin and overdose due to loss of heroin tolerance. Contingency management (CM) can improve medication adherence, but remote delivery using technology may be resource-light and cost-effective. We developed an innovative way to deliver CM by mobile telephone. Software monitors patients' attendance and supervised methadone consumption through an internet self-login at the pharmacy and sends reinforcing text messages to patients' mobile telephones. A linked system sends medication adherence reports to prescribers and provides early warning alerts of missed doses. A pre-paid debit card system provides financial incentives.
Innovation During COVID-19: Improving Addiction Treatment Access. [2021]: During the COVID-19 pandemic, many addiction treatment and harm reduction organizations have had to reduce their hours and services for people with substance use disorders, placing these individuals at increased risk of death. In order to address restricted treatment access during COVID-19, guidance from the Substance Abuse Mental Health Services Administration, the US Drug Enforcement Administration, and the US Department of Health and Human Services has allowed for use of audio-only telehealth encounters for buprenorphine induction without requiring an in-person evaluation or video interface. This has enabled innovations in order to try to meet the needs of the most vulnerable among us during the current pandemic. In this new regulatory environment, we established the Rhode Island Buprenorphine Hotline, a phone hotline which functions as a "tele-bridge" clinic where people with moderate to severe opioid use disorder can be linked with a DATA 2000 waivered provider who can provide an initial assessment and, if appropriate, prescribe buprenorphine for unobserved induction and linkage to outpatient treatment. In this correspondence we briefly share our experience developing this common sense approach to addressing the complex problem of access to treatment only now permissible due to regulatory changes during COVID-19.
Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16 mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.
A promising recovery housing model for American Indian communities. [2020]In 2016, two Oxford House (OH) recovery homes were established for the Suquamish Tribal reservation. A group of researchers interviewed house members and key individuals responsible for the creation of these two unique OHs. Because American Indians are an at-risk population for substance use disorders, our study explored whether an OH-type recovery home model could be successfully adapted to this population, given the specific nature of tribal cultures. Findings indicated that the residents, composed of both American Indians and non-American Indians, found these OHs to be supportive of recovery in general and with the values of American Indians. The tribal community's positive attitudes toward these recovery homes may have been due to similarities between the Suquamish Tribal Government and OH's democratic structures, with all individuals having a voice in the decision making process. The overall findings suggest that these types of culturally modified recovery settings on American Indian tribal lands could be an important resource for individuals dealing with substance use disorders.
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]Opioid use disorder (OUD) is a serious health condition that is effectively treated with buprenorphine. However, only a minority of people with OUD are able to access buprenorphine. Many access points for buprenorphine have high barriers for initiation and retention. Health care and drug treatment systems have not been able to provide services to all-let alone the majority-who need it, and many with OUD report extreme challenges starting and staying on buprenorphine in those care settings. We describe the design and protocol for a study of a rapid access buprenorphine program model in six Washington State communities at existing sites serving people who are unhoused and/or using syringe services programs. This study aimed to test the effectiveness of a Community-Based Medication-First Program model.
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]American Indian and Alaska Native (AI/AN) populations are disproportionately affected by substance use disorders (SUDs) and related health disparities in contrast to other ethnoracial groups in the United States. Over the past 20 years, substantial resources have been allocated to the National Institute on Drug Abuse Clinical Trials Network (CTN) to disseminate and implement effective SUD treatments in communities. However, we know little about how these resources have benefitted AI/AN peoples with SUD who arguably experience the greatest burden of SUDs. This review aims to determine lessons learned about AI/AN substance use and treatment outcomes in the CTN and the role of racism and Tribal identity.
The Native American healing experience. [2008]Recovery from addiction to alcohol and other drugs is taking place with the assistance of culture-specific methods in American Indian and Alaska Native communities in North America. These communities utilize many of the recovery approaches that make up today's best practices, but they also use their own cultural and ethnic strengths as an important part of their addictions recovery. The Wellbriety Movement among Native people is one such expression of culture-specific healing for North Americans having the heritage of indigenous peoples. The rallying call, "Our culture is prevention," expresses an approach unique in addictions recovery processes anywhere.