Funded Projects

NOFO Title: Development of a Device to Objectively Measure Pain (R43/R44)
NOFO Number: RFA-DA-18-012
Summary:

Even though pain is a nearly universal experience, objective measurements of pain remain difficult. Given that responding to the opioid crisis will require both better ways to manage pain and better ways to detect drug-seeking behavior, finding approaches to objectively measure pain is crucial. The goal of this project is to develop a product that will objectively measure pain using computer vision and machine learning technologies together with tablet-based self-reported pain data from patients for research or clinical purposes. The product will be low cost, involving one or two cameras to record the video and a computer to analyze the video in almost-real time, and will involve software that can be portable to ordinary personal computers and tablets. The project will capture facial expressions related to genuine pain and integrate it with patients’ self-reported pain data, in order to refine the product and create an objective measure of pain intensity that can be used in clinical settings and test its accuracy. This new tool has the potential to help rectify the poor pain outcomes that still plague Americans with opioid addiction, cancer, and other health conditions in many health care settings.

NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160
Summary:

Chronic low back pain (CLBP) is a problem affecting millions of Americans. Psychosocial approaches are efficacious for addressing the multidimensional nature of CLBP. Three of the most widely implemented nonpharmacological techniques for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). However, there is a critical lack of research examining if these techniques work via the mechanisms specified by theory. Ecological momentary assessment (EMA) and ActiGraph technology embedded within a randomized controlled trial, consisting of daily measures of process and outcome, is ideal for testing mechanism models both during treatment and during the critical period following treatment. The current proposal seeks to utilize EMA and ActiGraph to examine if changes in cognitive content, cognitive process, and activity level are mechanisms specific to CT, MM, and BA, respectively, for reducing pain interference. Elucidating the mechanisms of pain coping skills will lead to streamlined CLBP interventions.

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:

Deaths from opioid overdose are highly preventable with early detection and administration of naloxone, but overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitation. There is an urgent, unmet need for a low-barrier, easily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapy. This proposal seeks to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioid- induced respiratory failure (i.e., overdose) and summon help. The software-only product, SecondChance, converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose.

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

Given the severity of the current opioid crisis, there is a pressing need to maximize the effectiveness of our interventions and increase retention in medication for opioid use disorder (MOUD) treatment. Measurement-based care (MBC), in which patient progress is regularly and systematically assessed to aid in treatment decisions, is a promising approach. Assessment tools are needed that can be administered quickly and that yield information that can be used to suggest improvements in treatment. In this study, the Investigator will conduct a series of analyses with data from the Brief Addiction Monitor (BAM), which has been selected for a national MBC initiative within the Veterans Administration. The goal of the work will be to derive and validate two new scales from the BAM. One scale is intended for use in opioid use disorder (OUD) specialty care programs. The second version is intended for use in primary care–based MOUD.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

With the exception of the Breathalyzer for alcohol, there is currently no available technology that can immediately identify neurologic impairment related to the use of licit or illicit drugs. The presently available methods for detecting opioids—which rely upon analysis of urine, blood, saliva, or hair—are expensive, time-consuming to implement, and can take days to deliver actionable information to meet the “fitness-for-duty” concerns of employers as well as the needs for immediate detection of drug use in the drug rehabilitation and public safety fields. This project intends to develop a non-invasive means of identifying temporary neurological impairment from prescription opioids using analysis of involuntary eye movements. The resultant biometric signature of opioid impairment will be incorporated into Zverex’s existing product library of oculomotor biosignatures, such as marijuana impairment and fatigue.

NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

Data from 2015 show that American Indians/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorder (OUD) and death from drug overdose. Of particular concern is the prevalence in emerging adults (ages 18-25), as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development. This study will develop and implement a culturally centered intervention to address opioid misuse among urban AI/AN emerging adults in California: POMANAYA (Preventing Opioid Misuse Among Native American Young Adults). POMANAYA will developed by adapting and enhancing our existing culturally sensitive prevention intervention program that uses motivational interviewing in AI/AN youth to address social network factors in emerging adults that amplify (or reduce) opioid and other drug use risk. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults.

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

Substance use disorders (SUDs) can have devastating consequences for people with serious mental illness (SMI). SUDs can increase morbidity and mortality and are associated with higher healthcare and social costs, homelessness, and incarceration. Unfortunately, despite the availability of effective treatments, most individuals with co-occurring SMI and SUD (COD) never receive SUD treatment. We propose to evaluate system, provider, and patient-level facilitators and barriers and develop an implementation strategy and toolkit to promote the use of medication-assisted treatment (MAT) for people with COD. Aims 1–3 seek to assess organizational capacity (at the system and provider level); organizational readiness (at the provider level); and perceived needs, attitudes, and preferences (at the patient level) to identify barriers and facilitators. In Aim 4, we will use findings from Aims 1–3 to guide development of the implementation strategy and toolkit, using stakeholder input and a systematic process for strategy development.

NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

In 2015–2016, there were over 2 million adults with an opioid use disorder (OUD); 62% had a co-occurring mental illness and 24% had a co-occurring serious mental illness. Despite the effectiveness of treatment, many individuals never receive it, and when treatment is provided, quality is low. This is a critical treatment gap in a vulnerable and stigmatized population. Collaborative care (CC) aims to address these gaps by improving access, quality, and outcomes in primary care patients with common mental health conditions. However, CC has never been tested with co-occurring disorders (COD). In the team’s CC model for COD (CC-COD), the CC team includes a behavioral health psychotherapist, medications for OUD, pharmacotherapy for depression and post-traumatic stress disorder (PTSD), motivational interviewing (MI), problem-solving therapy, and Seeking Safety. A multisite, randomized pragmatic trial will be conducted to adapt, harmonize, and then test whether CC-COD improves access, quality, and outcomes for patients with comorbid OUD and depression and/or PTSD.

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

Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA.

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

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

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:

Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.

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

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

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

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.