Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UG1DA013732-19S4
Validation of a Community Pharmacy-based Prescription Drug Monitoring Program Risk Screening Tool (PHARMSCREEN) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA University of Cincinnati WINHUSEN, THERESA M Cincinnati, OH 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Community pharmacies are optimal—yet underutilized—settings for identifying individuals with opioid use disorder (OUD) and increasing their access to treatment. Approximately 93 percent of individuals in the U.S. live within 5 miles of a community pharmacy. The most common opioid-related tool available to pharmacists is the prescription drug monitoring program (PDMP), which provides highly limited information and support for clinical decision making. Appriss Health, the largest U.S. PDMP vendor, covering 42 states, has developed an opioid risk measure, the NarxScore. This study will clinically validate the NarxScore metric and identify high, moderate and low opioid risk thresholds to inform OUD care management within urban and rural community pharmacies. This is a prospective cross-sectional comprehensive OUD risk and behavioral/physical health survey administered electronically with patients (n = 1,523) filling opioid medications in urban/rural community pharmacies in Ohio (pharmacy sites: n = 12) and Indiana (pharmacy sites: n = 3), states that continue to have disproportionately high rates of overdose and opioid prescribing. Correlation, regression and kappa statistics will be calculated for validation; receiver operating curves with sensitivity/specificity values will be employed for threshold identification (with >95 percent power to detect an area of 0.7 under the curve value).

5R01AI132030-02
MINING REAL-TIME SOCIAL MEDIA BIG DATA TO MONITOR HIV: DEVELOPMENT AND ETHICAL ISSUES Translation of Research to Practice for the Treatment of Opioid Addiction NIAID UNIVERSITY OF CALIFORNIA LOS ANGELES YOUNG, SEAN Los Angeles, CA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Social big data analysis of publicly available user data on social media platforms is a promising approach for attaining organic observations of behavior that can monitor and predict real-world public health problems, such as HIV incidence. In preliminary research, our team identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors), modeled them alongside CDC statistics on HIV diagnoses, and found a significant positive relationship between HIV-related tweets and county-level HIV cases. We propose to create a single automated platform that collects social media data, identifies and labels tweets that suggest HIV-related behaviors, and predicts regional HIV incidence. We will interview staff and participants at local and regional HIV organizations to understand ethical issues associated with mining people’s data. The software developed from this application will be shared with HIV researchers and health care workers to combat the spread of HIV.

1UG3DA047793-01
TDCS TO DECREASE OPIOID RELAPSE New Strategies to Prevent and Treat Opioid Addiction Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder NIDA Butler Hospital ABRANTES, ANA M.; STEIN, MICHAEL D PROVIDENCE, RI 2018
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-18-494
Summary:

Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.

1R34DA050237-01
6/6 Planning for the HEALthy Early Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M; STEPHEN, JULIA MARIE Albuquerque, NM 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

The Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development of children beginning prenatally through ages 9–10 and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The planning study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 working groups. By the end of the planning phase, the 6 consortium sites will have produced and tested a recommended protocol for the future multi-site study and will have established feasibility of carrying out the study protocol at each of the 6 linked sites.

3UG1DA040316-04S3
A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA HENNEPIN HEALTHCARE RESEARCH INSTITUTE BART, GAVIN; JOSEPH, ANNE Minneapolis, MN 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This health care data mining study analyzes existing Veterans Health Administration data sets to examine patient and organizational characteristics associated with buprenorphine termination during outpatient OUD treatment. This project will generate data useful for predictive modeling on how to implement targeted approaches to improve retention in OUD treatment. An objective is to identify patient, provider and system targets to reduce unnecessary or inappropriate discontinuation of buprenorphine care. These analyses are critical for establishing initial constructs to evaluate reasons for treatment discontinuation based upon patient, provider and system factors in different health care settings.

3UG3DA047720-01S1
Evaluation of safety and pharmacokinetics of naltrexone implant Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE Bisaga, Adam New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

New medication treatment approaches are needed to help address the severe epidemic of opioid use disorder (OUD) and opioid overdose deaths in the U.S. Currently available medications, such as methadone, buprenorphine, and extended release injection naltrexone (XR-NTX; trade name: Vivitrol), are highly efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping treatment prematurely and relapsing. The goal of this proposal is to develop an innovative long-acting subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI), toward FDA approval. Expected to produce naltrexone blood levels sufficient to block the effects of opioids for 6 months after implant, OLANI circumvents the need for adherence to monthly injections with XR-NTX and could represent an important new addition to the medical armamentarium for treatment of OUD.

3UG1DA013727-20S4
Peer Recovery Support: A Bridge to Treatment for Overdose Survivors Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Medical University of South Carolina Brady, Kathleen Charleston, SC 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Innovative interventions being conducted in emergency departments (EDs) for the treatment of opioid use disorders (OUD) have engaged more OUD individuals in treatment and saved lives. However, individuals who present to the ED following an opioid overdose, particularly those who have received naloxone reversal, are often resistant to accepting treatment. An innovative state-funded project called FAVOR Overdose Recovery Coaching Evaluation (FORCE) was initiated to try to address this problem wherein trained peer recovery coaches are called to the ED as soon as an opioid overdose victim is admitted. The proposed project will assess the feasibility and replicability of this model, assess whether the FORCE approach leads to more opioid overdose survivors entering formal substance use disorder treatment at one month compared to treatment as usual, and assess whether the FORCE approach leads to better retention in SUD treatment for OUD overdose survivors over time.

3UG1DA040314-04S5
OUD Phenotyping Feasibility for Clinical Trials Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY Oakland, CA 2019
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.

1R21DA049861-01
Impact of SB 273 on West Virginia Patients, Providers and Overall Prescription Rates of Opioid Medications New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA West Virginia University Cara Sedney; Treah Haggerty Morgantown, WV 2019
NOFO Title: Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional)
NOFO Number: PAR-19-064
Summary:

In 2018, new opiate prescribing limits (SB 273) were implemented across West Virginia to combat the opiate misuse epidemic. This study will utilize quantitative and qualitative measures to determine the effect of the recent opiate prescription laws in West Virginia, how a change in policy affects the opiate misuse epidemic, and how communities may apply this knowledge more broadly. The research team will: 1) collaborate with the West Virginia Board of Pharmacy to ascertain changes in opiate prescribing habits before and after the start of SB 273 using an interrupted time series methodology, and 2) achieve broad and deep understanding of how SB 273 has affected prescribing practices and experiences amongst primary care physicians, specialists (pan physicians, surgeons, emergency room physicians, etc.), and patients who currently or previously utilized opiate medications.

1UG3DA047711-01
Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine Components Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE COMER, SANDRA D; PRAVETONI, MARCO New York, NY 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

The current studies are designed to examine a novel approach to treating OUD, namely use of a vaccine (OXY-KLH) targeted against oxycodone, one of the most commonly misused prescription opioids, and a vaccine (M-KLH) targeted against heroin/morphine. The researchers will evaluate the safety, immunogenicity, and preliminary efficacy of OXY-KLH and M-KLH. Overall, the proposed studies will provide a great deal of information about the safety and potential efficacy of the vaccines in reducing the addiction liability of opioids, which will be administered in a controlled laboratory setting. If the outcomes of the proposed studies with OXY-KLH and M-KLH are favorable, development of the bivalent vaccine (OXY-KLH plus M-KLH) that will target oxycodone and heroin will proceed. The long-term goal of this research is to develop a multivalent vaccine directed against oxycodone, heroin, and other relevant opioids.

1UG3DA050235-01
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA RAND CORPORATION D'AMICO, ELIZABETH J (contact); DICKERSON, DANIEL LEE Santa Monica, CA 2019
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.

1R61AT010604-01
Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Tennessee DEREFINKO, KAREN J Knoxville, TN 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

This application will develop and execute a sequential multiple assignment randomized trial (SMART) design to test two forms of behavioral economics intervention to promote medication-assisted treatment (MAT) for opioid use disorder. The two interventions, in person, brief motivational interviewing and substance-free activities intervention (BMI+SFAS), initially will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment and then be tested by SMART for its ability to promote MAT adherence. This innovative SMART design that tests two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of opioid use disorder patients in treatment and address an underserved population with opioid use disorder who is resistant to MAT adherence.

1R43DA049650-01
Patient-level Risk Identifier Models for a Multifactor Opioid Abuse Risk Assessment Strategy Cross-Cutting Research Small Business Programs NIDA PRINCIPLED STRATEGIES, INC. DuBose, Paul ENCINITAS, CA 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

This project, a partnership with Principled Strategies, will develop innovative, patient-level models for opioid risk identification and integrate them into the SafeUseNow managed care system—an actionable solution for combating prescription drug abuse that currently operates at the prescriber level only. Incorporating patient-level risk identifier models will strengthen an already powerful and demonstrably effective program and constitutes a critical step in generating a first-in-class, multifactor risk assessment strategy that is truly holistic. Using a variety of data sources, advanced analytics, and multiple empirically validated risk identification models, the groundbreaking advancement in SafeUseNow technology will enable health care stakeholders to identify combinations of prescribers, patients, and pharmacies whose behaviors may contribute to prescription drug abuse. This project will work to obtain new datasets for analysis, assess them, and use them to build national patient-level risk models for relevant outcomes, which will enable the development and evaluation of a next-generation prototype for a patient-level version of SafeUseNow.

1R34DA050291-01
1/4 Investigation of opioid exposure and neurodevelopment (iOPEN) Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA OREGON HEALTH & SCIENCE UNIVERSITY GRAHAM, ALICE M (contact); FAIR, DAMIEN A Portland, OR 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide, creating an urgent need to identify how in-utero exposure to opioids and associated risk factors influence the developing brain. A multidisciplinary team will address these challenges in Oregon, a state particularly hard hit by the opioid epidemic. Through linking sites, the impact of the Phase I project is enhanced and will provide critical information to support a national-level effort for Phase II of the HEALthy Brain and Child Development Study. Aim 1 will develop, implement, and evaluate innovative recruitment and retention strategies for high-risk populations. Aim 2 will address anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized research protocol including multimodal MRI of placenta, fetus, neonate, and 24-month-old brain; biospecimen collection; and assessment of substance use and other key domains. Aim 3 will evaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites.

1R34DA050285-01
3/5 The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A College Park, MD 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.

1R43DA050395-01
Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse Cross-Cutting Research Small Business Programs NIDA SYNVENTA, LLC GOMTSIAN, ARTOUR Tucson, AZ 2019
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:

With nearly 116 million people suffering from chronic pain in the United States, there is a need for new analgesics without the risks posed by opioids. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Initial tests in humans have confirmed that this class of drugs produces analgesia and is safe and well-tolerated, but side effects include hyperthermia and partial loss of heat sensitivity, leading to most research being halted. This project will conduct a set of preclinical proof-of-concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable, or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists.

1UG3DA050325-01
Use of a GLP-1 Agonist to Treat Opioid Use Disorder in Rats and Man Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Pennsylvania State University Hershey Medical Center Grigson, Patricia Hershey, PA 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

High relapse rates among people with opioid use disorder (OUD) indicate that addiction involves appetitive pathways. Peripheral stimulation of the glucagon-like peptide-1 receptor (GLP-1R) “satiety” pathway could reduce heroin seeking and taking. Pretreatment with a GLP-1R agonist reduces heroin taking, seeking, and drug-induced reinstatement in rats. This project tests whether GLP-1R agonists can reduce relapse in humans with OUD. A pilot study will be conducted to determine whether once-daily treatment with the shorter acting GLP-1R agonist, liraglutide, can safely and effectively reduce cravings among OUD patients. Animal models will be used to test the efficacy and safety of a longer-acting GLP-1R agonist, semaglutide, and then a clinical trial will be conducted to test whether semaglutide will reduce relapse and use in animal models. If successful, the study will show that treatment with GLP-1R agonists can safely and effectively reduce opioid craving, seeking, and relapse.

1UG3DA050308-01
Clinical Evaluation of C4X3256, a Non-Opioid, Highly-Selective Orexin-1 Receptor Antagonist for the Treatment of Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Indivior Heidbreder, Christian North Chesterfield, VA 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

There is a need for pharmacologic treatment options for opioid use disorder (OUD) that do not pose addiction liability and do not require complete withdrawal from opioids prior to treatment. Nonclinical studies support a role for the orexin system in drug seeking; compounds that selectively block signaling at the orexin-1 receptor (OX1R) reduce drug use. C4X3256, a non-opioid, highly selective OX1R antagonist, has a long residence time at the OX1R along with reduced intravenous self-administration and cue-induced reinstatement in animal models of nicotine addiction, suggesting it could be an addiction treatment. Proposed studies will move C4X3256 from preclinical development through Phase I testing in subjects with OUD. The clinical, preclinical, and supporting pharmaceutical development studies proposed will allow C4X3256 to move to Phase II studies.

1UG3DA050323-01
Cannabidiol in the treatment of opioid use disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Icahn School of Medicine Mount Sinai Hurd, Yasmin New York, NY 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Responding to urgent calls for non-opioid treatment, this research group has been evaluating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid, for the treatment of some clinical aspects of opioid use disorder (OUD). Preclinical animal studies show that CBD decreases cue-induced heroin-seeking behavior during drug abstinence, associated with incubation of craving. Clinical work has also shown that CBD was safe in combination with a potent opioid agonist to address a potential relapse condition and decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder. Building on this foundation, the researchers will investigate an oral CBD powered by a novel patented technology (leveraging the kinetics of long-chain fatty acid absorption) in a gelcap delivery system that improves bioavailability, reduces the incidence of gastrointestinal side effects, reduces first pass metabolism, and enhances onset time. This study could lead to the development of a non-opioid, non-intoxicating FDA-approved medication to reduce opioid craving and relapse and restore global functioning in individuals with OUD.

3R01AT008559-02S1
MECHANISMS OF PSYCHOSOCIAL TREATMENTS FOR CHRONIC LOW BACK PAIN New Strategies to Prevent and Treat Opioid Addiction NCCIH University of Washington JENSEN, MARK P; DAY, MELISSA ANNE SEATTLE, WA 2018
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.

1R44DA050375-01
A Novel Workflow to Screen for Illicit Drug Exposure in Newborns Cross-Cutting Research Small Business Programs NIDA BAEBIES, INC. KENNEDY, ADAM Durham, NC 2019
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:

Rates of neonatal abstinence syndrome (NAS) have skyrocketed during the last decade, and estimates suggest that 5% of mothers use at least one addictive drug during their pregnancy. To address this public health crisis, multiple groups—including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics—recommend universal screening of substance use in pregnancy using standardized behavioral scoring tools. Unfortunately, such tools are often biased due to subjective scoring or self-reporting errors, and fail to identify babies who did not receive proper prenatal care. This project will develop a fast and accurate NAS screening tool that pairs a simple sample preparation protocol with a high-sensitivity panel of homogeneous enzyme immunoassays recognizing five common classes of drugs: fentanyl, morphine, amphetamine/methamphetamine, cocaine, and benzodiazepines. The potential benefits of such a system include reduced length of hospitalization for unaffected newborns, accelerated time to confirmatory results (under 2 hours), faster resolution of acute withdrawal symptoms, and improved referral to family/maternal support services.

3R01AR069557-03S1
USE AND SAFETY OF OPIOIDS IN PATIENTS UNDERGOING TOTAL JOINT REPLACEMENT New Strategies to Prevent and Treat Opioid Addiction NIAMS Brigham And Women's Hospital KIM, SEOYOUNG CATHERINE Boston, MA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Over 30% of adults aged 65 years and older in the United States suffer from osteoarthritis (OA). Opioid analgesics are often used for patients with moderate to severe symptomatic OA. When non-pharmacologic and pharmacologic treatments are not effective, patients with severe OA may undergo total joint replacement (TJR). Our primary objectives are to evaluate patterns of opioid use before and after TJR and to assess the effect of opioid use patterns on clinical outcomes and safety events in a large U.S. population–based cohort of OA patients. The specific aims are to: 1) identify predictors of persistent opioid use and opioid dose escalation in patients after TJR for hip or knee OA and 2) evaluate effects of opioid use patterns on short- and long-term clinical outcomes and safety following TJR. The results of this study will provide guidance on surgical risk stratification and pain management of patients before and after TJR.

1R34DA046635-01A1
Treatment of chronic low back pain with transcutaneous auricular vagus nerve stimulation Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MASSACHUSETTS GENERAL HOSPITAL Kong, Jian Boston, MA 2019
NOFO Title: Behavioral & Integrative Treatment Development Program (R34 Clinical Trial Optional)
NOFO Number: PA-18-073
Summary:

Low back pain (LBP) is one of the most common reasons for all physician visits in the U.S. The financial costs associated with the care of LBP are staggering. The treatments for chronic low back pain (cLBP) are far from satisfactory, and opioids are often prescribed with varying degrees of success. This study builds on prior work suggesting that auricular transcutaneous vagus nerve stimulation (tVNS), a non-invasive therapeutic, can significantly reduce symptoms of chronic pain and common comorbidities of chronic pain, such as depression and anxiety. This proposal aims to investigate the treatment effect and underlying mechanism of tVNS on chronic low back pain. Patients with chronic low back pain will be randomized to either real or sham tVNS treatment for 1 month, with a 3-month follow-up. This study, if successful, could provide new treatment options for chronic low back pain and reduce the use of opioid analgesics in chronic pain management.

1R43DA050338-01
A universal approach for improving the limit of detection for fentanyl and fentanyl derivatives in urine Cross-Cutting Research Small Business Programs NIDA CERES NANOSCIENCES, LLLP LEPENE, BENJAMIN SCOTT MANASSAS, VA 2019
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
4R33AT010117-02
Mindful Moms in Recovery: Yoga-based mindfulness relapse prevention for pregnant women with opioid disorder Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH DARTMOUTH COLLEGE LORD, SARAH E Hanover, NH 2019
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002