Funded Projects

NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Women with opioid use disorder (OUD) are disproportionately impacted by physical, sexual, and psychological intimate partner violence and posttraumatic stress disorder (PTSD). Yet, treatment approaches that address all these conditions together in OUD treatment settings are lacking. To address this gap, this project will evaluate delivery of two evidence-based interventions to address PTSD (Present-Centered Therapy+ and Helping to Overcome PTSD through Empowerment) for women seeking OUD treatment who have experienced intimate partner violence. It will also determine if integrated treatment can help retain the women in medication treatment for OUD.

NOFO Title: HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional)
NOFO Number: DA22-047
Summary:

Compared to people with stable housing, individuals experiencing homelessness are more likely to use both fentanyl and stimulants and experience drug-related harms. This project will examine fentanyl-stimulant polysubstance use patterns and how they evolve over time in response to changes to housing status. It will also assess use of overdose prevention and substance use disorder treatment interventions in homeless individuals who use both fentanyl and stimulants, including how polysubstance use patterns shape their risk of overdose over time. This research will also interact with community stakeholders toward translating the findings into future research, policy, and program recommendations.

NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-054
Summary:

Computerized clinical decision support tools offer a promising strategy to standardize and scale evidence-based practices to keep pace with the dynamic nature of the opioid crisis and overcome barriers to substance use disorder treatment. To change practice, such tools must be useful, usable, able to be integrated into routine care delivery, and supported by a multicomponent implementation strategy. This project will refine and evaluate the uptake, usability, and equity of a nationally disseminated multicomponent clinical decision support intervention to increase initiation of medication treatment for opioid use disorder in the emergency department.

NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1 - Clinical Trial Required)
NOFO Number: RFA-DA-19-016
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. Columbia University is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent admin Supp Clinical Trial Optional)
NOFO Number: PA-20-272
Summary:

The science of recovery support services for individuals choosing to take medications for opioid use disorder as part of their recovery pathway is gaining momentum and will benefit from a dedicated, sustainable cross-project research infrastructure. This project enhances research in the existing Consortium on Addiction Recovery Research Science. This effort coordinates varied research and training efforts across recovery support research projects, amplifies communication and dissemination channels for their activities, and is organizing the first national meetings on addiction recovery support services science.

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

Harm reduction supplies include fentanyl test strips that allow people who use drugs to identify whether the substance(s) they plan to take contain fentanyl and sterile syringes that help to prevent the spread of infectious diseases among people who inject drugs. One potential way to increase access to harm reduction supplies is mail delivery. This project will describe state-level policies that deter the use of mail-based delivery of harm reduction services, examine characteristics of people who use mail-based harm reduction services, and assess individual preferences related to mail-based harm reduction services.

NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

There has been a substantial increase in overdose deaths among Black and Hispanic/Latino people who use drugs. This project will test and evaluate delivery of harm reduction services from a mobile van. A community-based care coordinator will assess the specific needs of each participant (such as housing, food assistance, and mental health treatment) toward the goal of linking each person to appropriate services.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The U.S. is in the midst of a devastating opioid epidemic. Since 1999, the number of overdose (OD) deaths involving opioids has quadrupled. These trends are magnified among American Indians/Alaska Natives (AI/ANs) compared to other racial/ethnic groups. AI/ANs are second only to Whites in the rate of OD mortality (8/100,000 versus 12/100,000 deaths, respectively). Medications for opioid use disorder (OUD; i.e., methadone, buprenorphine and naltrexone) are considered the most effective treatment, reducing mortality and increasing abstinence and retention. However, numerous barriers limit the uptake of medications for OUD in tribal communities and within urban treatment settings serving AI/AN individuals. This is a two-phase formative research study to develop and test an implementation intervention for programs to provide medications to treat OUD specifically with AI/AN consumers. The objective of Phase I (12 months) is to develop a culturally centered implementation intervention to integrate medications for opioid use disorder (MOUD) into health care/addiction specialty settings. The objective of Phase II (24 months) is to conduct a preliminary test of the implementation intervention at four sites serving AI/AN communities. Community-based participatory research (CBPR) methods will be used throughout both phases. This study will help with decreasing stigma and increase the utilization of MOUD in health care settings that serve AI/AN populations.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.

NOFO Title: HEAL Initiative: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-043
Summary:

Safe and stable housing is widely considered to be critical to recovery from alcohol and drug use disorders. Therefore, providing dedicated safe and substance-free housing options for individuals in recovery (recovery housing) may be an essential component of a comprehensive response to the current opioid crisis. However, there is limited evidence about effective recovery housing practices for individuals choosing treatment with medications for opioid use disorders as part of their path to recovery. This project will enhance the infrastructure necessary to study the effectiveness of recovery housing for these individuals. It will develop a national multi-stakeholder network, host webinars for researchers and recovery housing providers, and support mentored pilot studies for new researchers seeking to study recovery housing.

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials.