CTN Trial Progress

Randomizations for Active Studies as of the August 15 Trial Progress Report.

CTN-0080 - Enrolled 99

CTN-0097 - Enrolled 415

CTN-0098 - Enrolled 65

CTN-0099 - Enrolled 1083

CTN-0099-A-1 - Enrolled 88

CTN-0100
Discontinuation - Enrolled 66
Retention - Enrolled 427

CTN-0101 - Enrolled 167

CTN-0107 - Enrolled 66

CTN-0108 - Enrolled 41

CTN AI/AN Protocol Updates

CTN-0096 - Culturally Centering Medications for Opioid Use Disorder (MOUD) with American Indian and Alaska Native Communities (Tribal MOUD)

Protocol CTN-0096 is a formative study to develop (Aim 1, Phase I, completed) and test (Aim 2, Phase II) a program-level implementation intervention to support four healthcare and addiction specialty programs serving American Indian and Alaska Native (AI/AN) communities in culturally centering the delivery of medications to treat opioid use disorder (MOUD).

Read more about Phase I and II in the complete update here.

We have thoroughly enjoyed getting to know our collaborative board members and community research partners as we work in partnership to reduce the substantial opioid-related health disparities in many AI/AN communities.

We are thrilled to share that our two Step 1 sites: the Native American Community Clinic (NACC) in Minneapolis, MN and the Anpetu Luta Otipi (ALO) clinic, Oglala Sioux Tribe (OST), in Kyle, SD, initiated the intervention phase in June 2022. This phase involves bimonthly workgroup meetings with providers, other staff, and project practice facilitators to explore and identify goals to enhance each program’s cultural centering of MOUD. Workgroup meetings are structured using implementation science strategies, including Indigenous implementation science frameworks. Congratulations to NACC and OST!

Our Step 2 sites: Southcentral Foundation (SCF) in Anchorage, AK, and the Sophie Trettevick Indian Health Center (STIHC), Makah Tribe, in Neah Bay, WA, who will begin the intervention in December 2022. Congrats and thanks to all of the CTN-0096 partner research sites!

Photo: Indian Pueblo Cultural Center, October 2019, Albuquerque, NM

CTN-0096-A-1 - National Medication-Assisted Treatment Survey of Substance Use Disorder Programs Serving American Indian and Alaska Native People

This study, CTN-0096-A-1, seeks to provide a detailed description of the use of MATs for Opioid Use Disorders in health care systems and substance use disorder treatment programs serving AI/AN communities, much-needed insights regarding the dynamics around the decision to implement such practices, and carefully formulated methods for more effective dissemination.

Study aims include 1) describe the use of MATs for Opioid Use Disorders in health care systems and substance use disorder treatment programs serving AI/AN communities; 2) describe the factors associated with the implementation of MATs for Opioid Use Disorders in these systems and programs; and 3) identify methods for more effective dissemination of MATs to health care systems and substance use disorder treatment programs serving AI/AN communities.

The study implementation was significantly impacted by the COVID-19 pandemic. As tribal clinics had to adapt to the unanticipated pandemic ridden environment many were left short-staffed and with less substance use treatment resources as priority was shifted to COVID-19 response. Under these circumstances, the research team found that most treatment centers did not have the capacity to engage with non-COVID related research activities. The recruitment strategy has been adapted and the study is currently actively recruiting and plan to close recruitment by the end of December 2022.

CTN-0118 - Examining the COVID-19 Public Health Emergency on Policy, Substance Use Disorder Treatment, and Resilience among American Indian and Alaska Native Communities

Since COVID-19 was declared a public health emergency, federal regulations guiding addiction services delivery were modified, including within American Indian and Alaska Native (AI/AN) communities. Changes included expansion of telemedicine and virtual behavioral health delivery, adjusting medication dosing strategies for opioid use disorder, and altering reimbursement and confidentiality policies and practices for addiction services.

Although these policy shifts were to promote availability and access, little is known about the adoption, implementation, and effectiveness of these changes among programs serving AI/AN communities. Rapid research on the dissemination, adoption, and implementation of federal addiction policies among AI/AN-serving addiction treatment programs, including the voices and lived experiences of relatives/consumers, is of vital importance.

The specific aims of CTN-0118 (Lead Investigator Katherine Hirchak) are to assess the dissemination, adoption, and implementation of COVID-19 policy and regulations at Tribal, state, and federal levels by adding quantitative questions about COVID-19 to the National Tribal Addiction Survey (CTN-0096-A-1; LI Doug Novins)

We have made progress and achieved several milestones in 2022. After successfully partnering with two Tribal communities, in addition to concerted recruitment efforts out of urban areas in the Pacific and Inland Northwest, we were able to surpass our original recruitment goal (N=50). We have completed interviews with 24 providers and 57 relatives/consumers (N=81). The qualitative codebooks have been developed and data analysis is underway. Read more about this study in the full update here.

CTN-0123 - Facebook Intervention for Preventing Opioid Relapse among American Indian Women: Wiidookaage'win Pilot Preparatory Study

The Wiidookaage’win study (CTN-0123), Lead Investigator Christi Patten, PhD, Mayo Clinic, MN) aims to use a community-based participatory approach to develop a culturally relevant social media intervention for reducing opioid relapse among American Indian and Alaska Native (AIAN) women. The opioid epidemic is a major public health problem that disproportionately affects Native communities influenced primarily by social determinants of health and historical trauma. While gender-specific factors for opioid relapse in women have been identified (i.e., perceived stress, lack of social support), gender-specific interventions for Native women do not exist.

Consistent with the cultural value of interdependence, social media-formed groups to prevent opioid relapse could lead to greater adoption and sustainability by encouraging collaborative efforts across generations of Native women and leveraging community resilience for coping with stress. The study concept was developed with Native community partners in Minnesota.

This single-site study focuses on AIAN women residing in Minnesota with at least 1 month of abstinence from illicit opioid use and current use of medication for opioid use disorder. The digital intervention to be developed is a private, hidden, moderated Facebook group that will be active for 3 months. The study's three phases will involve qualitative interviews, development of the Facebook content library and a moderator exchange, and beta-testing. Read more about this protocol in the complete update here.

A community advisory committee (CAC) was formed comprised of AIAN women with lived experience, health care providers, and AIAN community partners. The CAC has met five times by Zoom to co-design the protocol and intervention and to guide all project activities. With the CAC, potential Facebook moderator postings were designed and iteratively refined to incorporate content (text, images, and videos) consistent with AIAN culture and values. At the advice of the CAC, a Native Elder woman named the study Wiidookaage’win which means "the place for help and time for helping" in Ojibwe and reflects healing and community.

A local Native artist developed original art for the study logo and Facebook posts (see graphic above). The research team has completed phase 1 interviews with 12 AIAN women and 9 interested parties to date and is generating preliminary response themes using content analysis. The moderator exchange is completed. The next steps are to refine the Facebook content library and conduct the beta-testing.

CTN-0129 - The Great Plains Initiative

Tribal communities in the Great Plains are diverse, and each has concerns and priorities to address addiction and recovery focused on local needs. There has been increasing concern about the use of opioids and methamphetamine, and data indicates that tribes in the Great Plains region (North/South Dakota, Nebraska, Iowa) suffer from many health and socioeconomic disparities at rates even greater than the other US tribal regions. Further, treatment resources in this region are geographically dispersed, adding to the already- long list of general barriers to substance use disorder (SUD) treatment.

CTN-0129 will build collaborations with reservation-based treatment centers and urban clinics serving AIs in the Great Plains to define treatment needs and to determine research priorities with tribal communities and not for them. Read about the study's 2 objectives in the full update here.

The Great Plains Initiative is a collaboration between CTN Ohio Valley Node researchers at the University of Cincinnati and at the University of North Dakota (LI: Donald Warne, MD). At present, the team is completing pre-initiation tasks, and has received the support of the Great Plains Behavioral Health Directors. Plans are underway to begin data collection at the two participating urban sites within the next few weeks. Work is in progress to obtain all necessary approvals for the six reservation-based programs who have expressed interest in study participation.

CTN-0078 - Knowledge of and Attitudes about Medications for Opioid Use Disorder Within Two Pacific Northwest American Indian Tribes

This study addresses critical barriers in the implementation of medication assisted treatment (MAT) for opioid use disorders (OUDs). MAT approaches have been shown to substantially improve outcomes for those with OUDs, yet provider and consumer/client knowledge, perceptions and beliefs about MAT, as well as organizational barriers to MAT use, are widespread. 

In some tribal communities there is a preference for total abstinence, and medications for OUD recovery are not well understood. Study results will inform future efforts to tailor MAT for high-need, low-resource American Indian/Alaska Native (AIAN) populations.

All data collection has been completed and the study team continues to collaborate with the communities to share study findings through presentations and discussions, reports and publications. Twenty-four semi-structured individual and group interviews were conducted with 58 community members with varying roles in the community: treatment center clients and providers, Tribal leaders, and other key community stakeholders.

Given the COVID 19 epidemic and the enormous effect on AIAN communities and treatment/recovery programs, additional interviews were conducted to assess the impact on mental health and substance use treatment during the pandemic. The team has analyzed data and has written two manuscripts for publication, pending community approvals.

News from the Nodes

Appalachian Node

The Appalachian Node is excited to announce Dr. Erin Winstanley, PhD, Associate Professor at West Virginia University, has been newly appointed as multi-PI. Dr. Judith Feinberg, is stepping down from that role as she has consolidated her professional commitments.

Dr. Feinberg remains actively involved in the Appalachian Node as a Co-Investigator.

Under the leadership of Drs. Liebschutz (University of Pittsburgh) and Winstanley, the Appalachian Node will continue to promote impactful research to address opioid use disorder.

New England Consortium Node

Dr. Edouard Coupet II, MD, MS, of Yale Department of Emergency Medicine, was awarded a Diversity Supplement. The title of the study is, Racial/Ethnic Disparities in Addiction Treatment Access for Opioid Use Disorder from the Emergency Department.

Brief Description: The emergency department (ED) represents an emerging setting to initiate medications for opioid use disorder and provide linkage to ongoing addiction treatment for Black and Latino populations with untreated OUD. Yet Black and Latino individuals with untreated OUD face significant disparities in access to ongoing addiction treatment following an ED visit. The goal of this proposal is to elicit potential targets for ED-based interventions that improve engagement in addiction treatment among Black and Latino individuals with untreated OUD. The specific aims are to: 1) conduct a qualitative study focusing on patterns of barriers and facilitators to engaging in addiction treatment among Black, Latino, and non-Latino White patients receiving ED-initiated buprenorphine treatment with a referral for continuation of OUD treatment outside of the ED and 2) evaluate differences among Black, Latino, and non-Latino White ED patients with untreated OUD on factors previously identified as predictors of worse treatment outcome, including opioid overdose, polysubstance use, major depressive disorder, and stigma, using supplemental analyses of data collected in CTN 0099. To accomplish this, we will conduct both semi-structured individual interviews of Black, Latino, and non-Latino White participants enrolled in CTN 0099 after they have completed their final 30-day assessments and supplemental analyses from data collected in CTN 0099. Study findings will inform the development of an ED-based intervention that enhances engagement in addiction treatment among Black and Latino populations subsequent to ED visit.

Western States Node

A piece titled Youth and Fentanyl: What Every Family Needs to Know on the OHSU news page reported on a recent roundtable discussion involving members of the Western States Node.

A surge of illicit fentanyl in the Pacific Northwest is supercharging an opioid epidemic with counterfeit pills that are 50 to 100 times more potent than heroin, cheap and readily available -- often to young people who make the potentially deadly mistake of viewing them as no more dangerous than cigarettes.

Oregon Health & Science University hosted a roundtable discussion Wednesday, June 29, to raise community awareness, especially among parents, school officials and health care professionals. The panel included Jennifer and Jon Epstein, parents who lost their son Cal after he overdosed on a counterfeit pain pill laced with fentanyl in 2020, as well as Todd Korthuis, MD, PhD, Ana Hilde, MD, MPH, Tony Vezina, Olivia Rae Wright, MD, Honora Englander, MD, and others.

New from the ATTC

How accessible are Opioid Use Disorder medications and what's stymying access? Two pieces in the latest ATTC Messenger (by Ned Presnall, LCSW and Kimberly A. Johnson, PhD, explore the question.

Embracing change: The fluidity of evidence-based SBIRT, by Diana Padilla of the Northeast & Caribbean ATTC explores a case study of an expanded application of SBIRT related to depression screening in Black churches. (ATTC/NIATx Service Improvement Blog)

Ohio Valley Node

Study updates from the Ohio Valley Node:

CTN-0080 - Medication treatment for Opioid use disorder in expectant Mothers (MOMs): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations

This study aims to evaluate the impact of treating Opioid Use Disorder in pregnant individuals with extended-release buprenorphine, compared to sublingual buprenorphine on mother and infant outcomes. UPDATE: The study experienced a pause in recruitment this past spring due to a gap in the XR medication supply. Upon resupply, 7 of the original 12 sites resumed recruitment, joined by a new site in West Virginia. The study is nearing its 100th randomization, which will be half of the target recruitment goal.

CTN-0125 - Using Integrative Data Analysis to Examine the Impact of Psychosocial Treatments for Black Cocaine Users Enrolled in the NIDA Drug Abuse Treatment Clinical Trials Network (CTN)

This study aims to evaluate the effectiveness of substance use disorder treatments for Black people who use cocaine and is a joint effort between the OVN, the WSN, and the NEC. Kathy Burlew (UC/OVN) and Lesia Ruglass (CCNY/WSN) are Co-LIs for this project. UPDATE: CTN-0125 has progressed to the first stage of data analyses of the 9 studies. Data harmonization is nearly complete, which will allow the team to move to the Integrative Data Analysis. A draft of a manuscript describing the protocol is in progress.

CTN-0114 - Drug Repurposing for Cocaine Use Disorder (CUD) Using a Combined Strategy of Artificial Intelligence (AI) – Based Prediction and Retrospective Clinical Corroboration (AI-4-CUD)

CTN-0114 includes three components. Stage I-a is the Artificial Intelligence (AI)-based generation of a list of promising candidate anti-cocaine use disorder (CUD) drugs. Stage I-b uses a limited data set of CUD-diagnosed patient electronic health record (EHR) data to identify prescribed medications associated with CUD remission diagnosis. Rong Xu (CWRU/OVN) is LI for this project with T. John Winhusen (UC/OVN) as Co-LI. UPDATE: Stages I-a and I-b have been completed and 87 candidates have been reviewed by the CTN Advisory Committee for potential inclusion in the third study component: Stage II. Stage II entails evaluating anti-CUD candidates using EHRs from 63 healthcare systems with over 86.2 million patients, including 315,183 patients diagnosed with CUD. Stage II has been completed for one candidate (ketamine) and a manuscript detailing the results has been submitted to the CTN PC. A Stage II evaluation of six additional candidates is planned and the potential to evaluate medication combinations will be explored.

CTN-0129 - The Great Plains Initiative

This project is a collaboration among OVN investigators at the University of North Dakota and University of Cincinnati along with treatment providers serving American Indian populations in the Great Plains to 1) determine community-defined needs for identifying and addressing SUD issues and 2) assess the feasibility and acceptability of telemedicine for MOUD. Donald Warne (UND/OVN) is the LI for this project. UPDATE: The study team is currently completing pre-initiation activities and hope to begin data collection within the next few weeks.

CTN-0134 - Buprenorphine-Precipitated Withdrawal Hotspots and Correlates: Identifying Regional "Hotspots" and Potential Correlates of Precipitated Withdrawal During Buprenorphine Induction in Fentanyl Users Through Prescriber Survey Responses and patient Urine Drug Test Results

This one-group, cross-sectional survey study will characterize the regional variability in the prevalence and correlates of prescriber-reported precipitated withdrawal during buprenorphine induction for individuals using fentanyl in approximately 279 counties in the United States. Millennium Health (MH) will provide urine drug test results from the counties of prescribers who participated in the survey. The urine drug test results and survey data will be merged to assess the association between precipitated withdrawal issues and fentanyl, fentanyl analogues, and other drugs of abuse. LaTrice Montgomery (UC/OVN) is LI for this project with T. John Winhusen (UC/OVN) as Co-LI. UPDATE: The team has currently enrolled 76 active buprenorphine prescribers to participate in the survey. The recruitment window is still open as they aim to reach our goal of recruiting at least 1 active prescriber from each county that has a practice that contracts with MH.

NIDA Racial Equity Initiative Funding Opportunity

NIDA has released new Funding Opportunity Announcements (FOAs) for the NIDA Racial Equity Initiative. These FOAs are focused on research to advance equity for racial and/or ethnic minority populations in the U.S.

A webinar is being offered on September 26, 2022 at 3pm ET for those interested in asking questions or learning more about these FOA.

Find more information here!

Upcoming Events

Facebook Live: The Intersection of Suicide and Substance Use.
September 15, 2022, 12:30-1pm ET (virtual)
This session, airing on NIDA's Facebook page, is in recognition of National Suicide Prevention Month in September.

2022 NIDA-NIAAA Frontiers in Addiction Research Mini-Convention
November 1-2, 2022 11am-3pm PT (virtual)
Provides a forum for presentations and discussions of current topics in neuroscience and addiction.