Funded Projects

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

Use of both opioids and stimulants is increasing, but little is known about how polysubstance use evolves over time and how it influences overdose risk. This project will use data from two groups at high risk for overdose: i) participants in the AIDS Linked to the IntraVenous Experience (ALIVE) study who inject drugs and ii)  participants in the new Stimulant Opioid Non-Injection Cohort (SONIC) study. This research will identify drug use patterns and their association with treatment and overdose over time – toward informing overdose prevention efforts and interventions to improve the U.S. opioid crisis.

NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
Summary:

During the COVID-19 public health emergency, the Substance Use and Mental Health Services Administration relaxed regulations for take-home dosing of methadone, offering an opportunity to improve methadone treatment access and address racial and ethnic disparities. This project aims to address regulatory, legal liability, and financial concerns related to clinical practice changes in opioid treatment programs. The project will first review state administrative data and conduct qualitative interviews to inform the intervention approach. The project will then evaluate an opioid treatment program intervention involving take-home methadone and its effect on take-home dosing, retention in care, and health outcomes for Black/African American and Hispanic/Latino individuals who take methadone for opioid use disorder.

NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Musculoskeletal pain is common, costly, and affects millions of Americans. Clinical guidelines strongly recommend complementary and integrative treatments such as physical therapy, but nearly half of people receiving physical therapy for musculoskeletal pain seek additional care. Additional treatments such as medication and surgery are more aggressive and carry higher risk. This project will use data from a large physical therapy dataset and nationwide medical claims data to investigate why some people do not respond well to physical therapy for musculoskeletal pain, toward finding safe and effective options for these individuals.

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

Although approximately 80% of people with opioid use disorder smoke cigarettes, tobacco use is rarely addressed in treatment of opioid use disorder. Moreover, smoking cessation interventions that are effective in the general population have been minimally effective among people with opioid use disorder. This project will integrate into methadone treatment programs the Mindfulness-Oriented Recovery Enhancement intervention and motivational interviewing to address use of tobacco and other drugs. This research will determine the value of this intervention compared to attending a support group or receiving motivational interviewing. The project will also examine use of tobacco, opioids, and other drugs, and whether people begin treatment. The research will also study implementation barriers and facilitators to the mindfulness-based approach as well as strategies to enhance its adoption into clinical practice.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-22-066
Summary:

Rigorous and impactful clinical pain research requires participant diversity that reflects the racial/ethnic diversity of affected populations. This project will enhance patient and other community engagement, particularly of underrepresented minorities, to participate in clinical research related to the transition of acute to chronic pain.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

People with opioid use disorder living in rural and underserved areas often have limited access to treatment. This project will develop a robotic treatment booth that allows opioid treatment centers to dispense opioid use disorder medications, while providing medical observation via real-time telehealth services. This new technology will provide a contactless patient–provider experience and leverage the expertise to expand treatment access to additional rural and underserved areas.

NOFO Title: HEAL Initiative: Pilot & Feasibility Trials to Improve Prevention and Treatment Service Delivery for Polysubstance Use (R34 Clinical Trial Optional)
NOFO Number: DA22-048
Summary:

Patients who use both opioids and methamphetamine often experience serious medical complications requiring hospitalization. While hospitalization provides an opportunity to start addiction treatment, linking patients to outpatient treatment after discharge is hard. This project will develop and conduct a pilot trial of an intervention that combines patient navigation with a mobile app offering financial incentives for outpatient treatment. This research will also develop outcome measures to describe participants’ use of healthcare and how it is influenced by baseline methamphetamine use. If effective, this patient-navigator-plus-mHealth approach could help reduce substantial gaps in treatment and retention for people who use opioids and methamphetamines simultaneously.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

Asian American women who have survived breast cancer and who also have depression are less likely to receive adequate pain treatment due to cultural stigma attached to breast cancer, cultural attitudes about living with pain and symptoms, and language barriers. This project will use a personalizable, technology-based approach to treat cancer pain and depression in Japanese American, Chinese American, and Korean American women who have survived breast cancer. The intervention will accommodate flexibility, accessibility, and anonymity: three factors that have historically hindered effective pain management for this population of breast cancer survivors.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3)
NOFO Number: PAR-20-092​
Summary:

Naltrexone is the only medication approved by the U.S. Food and Drug Administration to prevent relapse from opioid use disorder. This medication remains underused because it must be injected into muscle by a nurse and is relatively expensive. This project will develop and test a novel naltrexone skin patch that is easier to use, more comfortable, and inexpensive.

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: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Fifty million Americans experience chronic pain, including about 25 million who report pain that substantially interferes with daily activities and reduces quality of life. Mental health problems, including depression, anxiety, and post-traumatic stress disorder, increase risk for severe chronic pain. This project will use genetic data, information about observable characteristics (phenotypic data), and neuroimaging data from three large databases to identify psychosocial factors that predict chronic pain, assess differences across diverse U.S. populations, and determine whether risk profiles predict post-surgical chronic pain.

NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327
Summary:

Currently no medications are approved by the U.S. Food and Drug Administration to treat cocaine use disorder, which compromises cognitive function associated with achieving goals such as working memory, the ability to update information, and mental flexibility. This project will test whether  stimulating dopamine activity in the brain with the drug rotigotine (approved to treat Parkinson’s disease) is effective for treating cocaine use disorder. Past research has also shown that rotigotine can improve nerve cell and cognitive function in Alzheimer’s disease. This project will conduct a clinical trial to test whether treatment with rotigotine combined with cognitive behavioral therapy can reduce cocaine use in people with cocaine use disorder.

NOFO Title: HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional)
NOFO Number: RFA-DA-22-034
Summary:

Many people intending to take medications for opioid use disorder, including buprenorphine, as part of their recovery pathway do not stay in treatment long enough to reduce risk for overdose. These individuals also often continue to use one or more other drugs during treatment, which may further raise their overdose risk. This project will develop and conduct a preliminary test of an innovative integrated intervention that combines buprenorphine treatment with recovery coaching and online cognitive behavioral therapy. This research will assess whether the approach reduces drug use during buprenorphine treatment and helps people stay in treatment longer.