Funded Projects

Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment.

The System of Safety (SOS) represents an opportunity to study the implementation of best practice suicide-related care processes that embody the Zero Suicide Essential Elements of Care across emergency departments, inpatient medical and behavioral health units, and primary care clinics associated with a large healthcare system. This effectiveness trial will use a stepped wedge design across a total of 39 clinical units. Aim 1 will measure suicide risk screening and screening's impact on risk identification. Aim 2 will measure the effective implementation of clinician-administered interventions, such as safety planning with means restriction counseling, on suicide, suicide attempts, and suicide-related acute healthcare. Exploratory aims will examine mechanisms of action, moderators, economics, and population effects of the intervention. This study's innovative approach positions it for a significant impact on the fields of suicide prevention, CQI, and effectiveness trial design and analysis.

Chronic low back pain affects millions of people in the United States, resulting in high medical costs and lost productivity. New opioid-free treatments are needed to help people with chronic low back pain, but not all people respond equally to a given approach. IMPACT aims to use machine learning to analyze data such as physical activity, sleep, emotions, and pain levels and identify markers that can help predict how effective a mindfulness-based treatment approach (Mindfulness-Based Stress Reduction) can be for people with chronic low back pain.

Side effects from taking the opioid receptor blocker naltrexone make it difficult for patients to adhere to treatment with this medication for opioid use disorder. Cannabidiol (CBD), a bioactive ingredient of cannabis, is not an opioid and is non-psychoactive. Previous research shows that CBD blocks opioid-seeking behaviors, craving, and withdrawal. This project will develop tiny particles containing CBD and low-dose naltrexone. The research will determine if this combined version of CBD and naltrexone helps people stay in treatment and prevents relapse without problematic side effects. 

This project creates the HEAL Data2Action Data Infrastructure Support Center that will conduct research as well as support the HEAL Data2Action Innovation Projects with analytics and support for navigating electronic health records and other “big data” sources, as well as logistical processes related to privacy and ethics. The center will help plan for data collection and assessing outcomes, as well as provide data visualization efforts for various stakeholders. Key support mechanisms include courses, seminars, conferences, trainings, and on-demand technical assistance.

The IMPOWR (Integrative Management of Chronic Pain and OUD for Whole Recovery) Dissemination, Education, and Coordination Center (IDEA-CC) will develop infrastructure to amplify and create momentum for the findings of the IMPOWR initiative and other linked research networks. This center will i) rapidly deploy a communication framework to link IMPOWR clinical sites with each other and the larger HEAL research frameworks; ii) develop an educational infrastructure addressing stigma and health disparities in patients with co-morbid chronic pain and opioid misuse/disorder; iii) disseminate research findings effectively to targeted audiences; iv) develop a novel composite screening tool for chronic pain and opioid misuse/disorder; and v) harmonize processes for data collection and common data elements of chronic pain and opioid misuse/disorder measures across the IMPOWR research centers, providing a coordinated platform for gathering data from these studies. This center will rapidly disseminate key findings to stakeholders, clinicians, and patients to improve the health and wellbeing of individuals with co-occurring chronic pain and opioid misuse/disorder.

This research provides support to strengthen data management, data sharing, and data readiness efforts within the HEAL Initiative. This support further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. It also provides an opportunity for existing HEAL Initiative award recipients to increase data “FAIR”-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets.

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.

Chronic musculoskeletal pain is common and often severe enough to be disabling. Some treatments such as cognitive behavioral therapies or analgesics may relieve pain for some, but not all patients. Combining effective therapies and providing support to ensure that patients are motivated to adhere to their treatment may prove to be more beneficial to patients than prescribing a drug or recommending a single non-pharmacological treatment. This study aims to evaluate a combination of complementary treatments and Registered Nurse (RN) support to motivate patients to use and maintain combined therapies. Some patients will receive phone-based motivational interviews with an RN to enhance their adherence to pain coping skills learned through web-based cognitive behavioral therapy in combination with duloxetine, a pain-relieving drug. Others will receive both treatments but will not receive support from an RN. The study aims to determine whether motivational nursing support enhances adherence to newly learned pain coping skills, and results in improved pain relief and physical function.

In collaboration with Eolas Therapeutics and the NIH Blueprint Neurotherapeutics Network, AstraZeneca has developed a novel compound for treatment of opioid use disorder, AZD4041, which targets orexin 1 (OX1) receptors in the brain. In animal studies, AZD4041 reduced the motivation to consume opioids or nicotine, reduced relapse-like drug-seeking behaviors, and showed a favorable safety profile. The compound also has proven to be safe in an initial Phase 1 clinical trial in healthy human volunteers. This project will further evaluate the safety (e.g., respiratory depression profile) of AZD4041 in human volunteers, using multiple and increasing doses. Upon successful completion of these studies, the compound will be tested in a proof-of-concept efficacy study in patients with opioid use disorder. If this is successful, the compound will advance to larger Phase 2 and Phase 3 pivotal clinical trial to tests its effectiveness in the treatment of opioid use disorder.

This project aims to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The study will focus on the development of the ADF with design aspects specifically focused on abuse through insufflation, smoking, injection, and taking multiple pills. The study will also validate the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent-Opioids-Evaluation and Labeling guidelines. The study could result in the development of a novel ADF that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design.

Buprenorphine is an effective treatment for opioid use disorder, but its use is limited due to the need for frequent dosing. This project will optimize the molecular features of an injectable, biodegradable, long-acting (3-month) buprenorphine implant that would not require surgical removal. The research aims to advance toward testing in human research participants.

Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost universally used for post-cesarean analgesia management. Studies suggest that most women are prescribed more tablets at discharge than needed. These often go unused, providing an important reservoir contributing to the opioid crisis. Physicians struggle to prescribe and dose postoperative opioids appropriately while tackling the real needs of acute pain from surgery. Without literature to guide obstetric providers on appropriate amounts of opioids to prescribe upon discharge, actual prescription amounts nationally vary widely by up to 65 tablets. To improve post-cesarean opioid prescribing practices without compromising pain management, the study will test an individualized, patient-empowered approach for pain management and opioid prescription quantity. This is a noninferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge.