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 Sort descending |
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1R34DA050263-01
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2/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF WISCONSIN-MADISON | OSSORIO, PILAR N | Madison, WI | 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 first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids. |
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3R21DA045092-01A1S1
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EVALUATING COGNITIVE AND DEVELOPMENTAL RISK FACTORS FOR OPIOID MISUSE AMONG ADOLESCENT CANNABIS USERS | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | University of Washington | RAMIREZ, JASON | Seattle, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: The opioid epidemic continues unabated in the United States, and despite the rapid expansion of this crisis, the nature of the risk factors that contribute to opioid misuse remain poorly understood compared with other substances of abuse. The goal of this project is to examine cannabis use and cannabis identification measures as risk factors for opioid misuse while also developing and evaluating novel implicit measures of opioid associations as risk factors for opioid misuse among an at-risk sample of adolescents. Findings from the proposed research are intended to improve the prediction of opioid misuse among adolescents and to potentially identify novel targets for prevention and intervention strategies that aim to combat the opioid epidemic. |
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3UG1DA013035-18S5
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Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | ROTROSEN, JOHN P; NUNES, EDWARD V. | 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: 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. |
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3R44DA044053-03S1
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DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE | Cross-Cutting Research | Small Business Programs | NIDA | emocha Mobile Health, Inc. | Seiguer, Sebastian | Owings Mills, MD | 2019 |
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302 Summary: Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-based application, miDOT, for office-based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners. |
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1UG1DA050069-01
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Kentucky Womens Justice Community Opioid Innovation Network (WJCOIN) | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | UNIVERSITY OF KENTUCKY | STATON, MICHELE STATON | Lexington, KY | 2019 |
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025 Summary: Women are disproportionately affected by the opioid crisis due to increased pain sensitivity, physician prescribing practices, and self-medication, as well as a faster trajectory from opioid exposure to the development of opioid use disorder (OUD). The University of Kentucky proposes to establish the Women’s Clinical Research Center as part of the NIDA Justice Community Opioid Innovation Network (W-JCOIN), with the overall goal of increasing initiation and maintenance of medications for OUD among high-risk justice-involved women in the transition from jail to the community to reduce opioid relapse and overdose. The KY W-JCOIN has the potential for significant impact on the OUD treatment field by contributing empirical evidence on the effectiveness and implementation of innovative technologies to increase initiation and maintenance of life-saving medications during a critical, high-risk time of community re-entry among vulnerable, justice-involved women in both urban and rural communities. |
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1UG3DA047699-01
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Development of ITI-333, a ?-opioid Receptor Partial Agonist and 5HT2A and D1 Receptor Antagonist, for the Treatment of Opioid Use Disorders | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | INTRA-CELLULAR THERAPIES, INC. | VANOVER, KIMBERLY E | 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: Deaths from opioid overdose continue to rise; from 2015 to 2016, there was a 28 percent increase in the number of fatal overdoses. Currently available pharmacotherapies include MOR agonists (e.g., buprenorphine) and antagonists (e.g., naloxone), all of which suffer from specific and clear limitations. To address some of the key limitations, Intra-Cellular Therapies Inc (ITI) is developing ITI-333, a novel compound with high-affinity activity at mu opiate (MOP), 5-HT2A, and D1 receptors, that lacks abuse liability and thus offers great promise for the treatment of opioid use disorders. This proposal is for a 2-year UG3 program, including a first-in-human, single ascending dose (SAD) study to assess the safety, tolerability, and pharmacokinetics of ITI-333 in healthy volunteers. This study will then be repeated in a single-center in-patient study with the goal of determining a maximally- tolerated dose (MTD) and completed with human abuse liability and functional pharmacology studies. Together, the researchers believe this clinical development plan will inform further development of ITI-333 and the selection of a cogent Phase 3 clinical path toward FDA approval as a medication for the treatment of OUD. |
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1UG1DA050072-01
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Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | YALE UNIVERSITY | WANG, EMILY AI-HUA | New Haven, CT | 2019 |
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025 Summary: Correctional settings have the potential to serve as key players in linking individuals with opioid use disorder (OUD) to treatment and health services upon release. Many individuals with OUD are being treated with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. The Transitions Clinic Network (TCN) program provides enhanced primary care and OUD treatment for people recently released from incarceration. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. This study will assess the effectiveness of the TCN: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association. |
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3UG1DA013732-20S2
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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 | 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). |
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1R01DE029187-01
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LIGHT and Lymphotoxin targeting for the treatment of chronic orofacial pain conditions | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NIDCR | UNIVERSITY OF TEXAS HLTH SCIENCE CENTER | AKOPIAN, ARMEN N | San Antonio, TX | 2019 |
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043 Summary: Mismanagement of orofacial chronic pain, such as temporomandibular joint and muscle disorders (TMJD) and oral cancer, substantially contributes to opioid overuse; overdose-related deaths; and cardiovascular, renal, and neurological complications at epidemic proportions. The current paradigm implies that orofacial conditions could trigger maladaptation of the immune system and plasticity supporting persistent inflammation, which influences the development and maintenance of orofacial chronic pain. LIGHT (TNFSF14) and Lymphotoxin-beta (LT?), members of the tumor necrosis factor superfamily, provide a balance between protective immunity and immunopathology during chronic inflammatory diseases. This project will test the hypothesis that targeting LIGHT and LT? signaling could prevent the development and inhibit the maintenance of chronic pain produced by TMJD and oral cancer, via peripheral mechanisms involving plasticity of immune, stromal, and tumor cells, as well as sensory neurons. The proposed research is significant as it advances our understanding of mechanisms regulating the development and maintenance of orofacial pain and offers new therapeutic targets and an immunotherapeutic approach for preventing and blocking chronic pain during TMJD and oral cancer. |
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1UG3DA047709-01
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An ultra-long-acting oral treatment for 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 | LYNDRA THERAPEUTICS, INC. | BELLINGER, ANDREW MARTIN | Boston, MA | 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: Buprenorphine (BUP) is an FDA-approved medication-assisted therapy (MAT) that improves outcomes and saves lives in patients with opioid use disorder (OUD). It is available in multiple dosage forms and routes of administration, including daily sublingual (SL) and buccal tablets and films, a monthly subcutaneous (SC) injectable, and a 6-month SC implant; however, these forms leave many patients untreated or undertreated. This product, in a partnership with Lyndra Therapeutics, aims to develop a once-weekly oral BUP dosage form for maintenance therapy for OUD, using a new oral dosage formulation developed by Lyndra. A long-acting oral BUP may address important limitations of current MATs by providing improved PK with less euphoria than SL, a patient- and provider-preferred route of administration, and an optimal dosing interval for improved patient adherence with the potential for cost-effective direct observed therapy. |
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3UG1DA013727-19S1
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Integrating Nurse Practitioner Buprenorphine Wavier Training into Graduate Nursing Curriculum | 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 T.; CARPENTER, MATTHEW J | 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: This proposal would address barriers to the NP’s ability to prescribe buprenorphine by incorporating waiver education into NP final semester curriculum. The initial eight hours of training would be provided to students in a face-to-face classroom setting or via live video streaming. The remaining 16 hours would be completed by the NP students through online modules offered by the AANP. Trained NP students would be eligible for one year of peer-to-peer mentorship and inclusion in the MUSC Project ECHO tele-mentoring for new providers. Outcomes to be tracked would be the number of NPs trained who obtain their waiver and the number of individuals treated with MOUD by the NPs trained. Secondary data collected would offer insight into wavier obtainment process and determine need for mentorship for newly waivered providers. |
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1R34DA050341-01
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4/6 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 CALIFORNIA, SAN DIEGO | CHAMBERS, CHRISTINA | La Jolla, CA | 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. |
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1UF1MH121949-01
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Patient-centered team-based primary care to Treat Opioid Use Disorder, Depression, and Other conditions | New Strategies to Prevent and Treat Opioid Addiction | Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions | NIMH | KAISER FOUNDATION RESEARCH INSTITUTE | DEBAR, LYNN L (contact); BRADLEY, KATHARINE ANTHONY | Oakland, CA | 2019 |
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: Some medications for opioid use disorder (MOUD) can be provided in primary care (PC). Systems of team-based PC show promise for improving access and retention in OUD treatment. One such model, collaborative care (CC), includes a care manager, supervised by experts, who help provide evidence-based high-quality OUD care. While CC improves outcomes of depression, other mental health and substance use (MH/SU) disorders and pain, it is unknown how to optimally integrate CC for OUD with other MH/SU disorders. This pragmatic trial tests whether our model of CC for OUD and comorbid conditions increases engagement in MOUD treatment and improves depression symptoms in PC patients with OUD and depression. Innovative pragmatic elements include inclusion of all eligible patients in participating PC clinics, random recruitment and consent, and measurement of main outcomes using only secondary data. These pragmatic elements avoid studying only motivated patients and avoid activating patients randomized to usual care. |
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1UG3DA048388-01
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Cannabidiol Effects on Craving and Relapse Prevention in 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 | INSYS DEVELOPMENT COMPANY | ELKASHEF, AHMED | Chandler, AZ | 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: To tackle the national public health emergency posed by opioid misuse, addiction, and overdose deaths, the development of effective new medications and the FDA drug approval process must be accelerated. In response to this call, INSYS Development Company, Inc. (INSYS) has developed a cannabidiol (CBD) oral solution that shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified in the HEAL Initiative to improve treatment options. The first phase of this project involves clinical trials of CBD on cue-induced cravings, modulation of withdrawal, alterations of negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this phase will inform further studies in an outpatient setting. If successful, this project could advance to the development of a new monotherapy for the treatment of OUD. |
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1UG1DA050067-01
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Massachusetts Justice Community Opioid Innovation Network (JCOIN) Clinical Research Center | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | BAYSTATE MEDICAL CENTER | FRIEDMANN, PETER D (contact); EVANS, ELIZABETH A | Springfield, MA | 2019 |
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025 Summary: A major driver of the U.S. opioid crisis is limited access to effective medications for opioid use disorder (MOUD) that reduce the risk of overdose. Traditionally, jails and prisons in the U.S. do not initiate or maintain MOUD for inmates with OUD prior to their return to the community, which places them at high risk for fatal overdose. The Massachusetts Justice Community Opioid Innovation Network (JCOIN) will study the outcomes and implementation of a 2018 state law that seven county jails must provide all approved forms of medication for OUD. The Chapter 208 initiative has important implications for future policy and practice in the justice and OUD treatment systems at the local, state, and national levels. |
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1R03DA046011-01A1
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Opioid sparing potential of light-induced analgesia: a pilot trial of a novel, non-pharmacological treatment for pain | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | DUKE UNIVERSITY | Gulur, Padma | Durham, NC | 2019 |
NOFO Title: NIDA Small Research Grant Program (R03 Clinical Trial Required)
NOFO Number: PA-18-634 Summary: Exposure to opioid analgesics during medical care is a key driver of the opioid epidemic. Such exposures are widespread. Yet opioids remain essential first-line agents in treating pain, and it remains vital that pain be appropriately managed. Non-opioid pain treatments help to resolve the opioid/pain conflict. This project will examine the opioid-sparing and pain-relieving potential of a novel, non-pharmacological treatment for pain, using the effects of green light exposure to reduce pain and thereby reduce the quantity of opioids needed for pain relief. |
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1R44DA049493-01
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A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | PEAR THERAPEUTICS, INC. | KERN, AUDREY; PALLONE, DAVINA | Boston, MA | 2019 |
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-014 Summary: Opioid use disorder (OUD) is a key driver of the current opioid epidemic in the United States, but nearly 80% of individuals with OUD do not receive treatment. Buprenorphine medication-assisted treatment (MAT) is an effective form of care for OUD. This project will develop a state-of-the-art, digital therapeutic tool that effectively promotes buprenorphine adherence by providing contingency management rewards and educational content and enables home induction using a new self-monitoring support tool. This tool, named reSET-O+, will be integrated with Pear Therapeutics’ reSET-O, an FDA market-authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for OUD. |
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1UG3DA047700-01
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Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and Opioid Use Disorders | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | MEBIAS DISCOVERY, LLC | KUO, LAWRENCE C | Philadelphia, 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: The adverse effects of morphine and other mu-opioid receptor (MOR) agonists are linked to the ?-arrestin pathway, while analgesia is tied to the G-protein pathway. Pathway specific or “biased” drug development can target G-protein specific agonists that avoid the negative consequences of ?-arrestin signaling activation and produce analgesia. Highly “biased” MOR agonists have promise as effective analgesics but devoid of opioid-induced adverse effects. Preclinical studies compared two compounds, MEB-1166 and MEB-1170, against Oliceridine and morphine. Both compounds displayed no respiratory depression, even at high doses, while morphine and Oliceridine significantly reduced respiratory function. In contrast to morphine, neither MEB-1166 nor MEB-1170 produced conditioned place preference, suggesting an absence of abuse liability. This study will characterize the pharmaceutical and pharmacological profiles and perform liability studies for these compounds. |
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1R21DA047662-01
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Human laboratory model to screen drugs with opioid analgesic-sparing effects: cannabidiol/morphine combinations | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | WAYNE STATE UNIVERSITY | Lundahl, Leslie H | Detroit, MI | 2019 |
NOFO Title: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
NOFO Number: PA-18-344 Summary: Chronic pain is a significant public health problem associated with tremendous personal and economic burden. First-line treatment consists of opioid medications, but despite only moderate efficacy and unpleasant side effects, rates of opioid prescriptions have quadrupled over the past 15 years, and this has contributed to high rates of misuse, overdose, and mortality. Clearly, alternative, or non-opioid strategies for treating pain are needed. In this context, “opioid-sparing” medications refer to compounds that can be combined with and enhance the analgesic effects of lower-dose opioids without increasing the rewarding properties of either drug. There is preclinical evidence suggesting that cannabidiol (CBD) may have the potential to function as “opioid-sparing” medications, but its ability to alter opioid-mediated analgesia in humans has yet to be determined. This proposal will fill this gap by conducting a double-blind, placebo-controlled, within-subject randomized crossover study of the effects of CBD and morphine co-administration on pain sensitivity and subjective reinforcement on 28 healthy males and females. This is the first known study to investigate the ability of CBD to alter morphine’s analgesic effects in humans. If successful, the model will have a lasting impact on our ability to develop and test medications that reduce our reliance on chronic use of opioid medications for pain relief. |
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1UG3DA048351-01
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A Phase I/IIa Clinical Trial Testing the Safety and Immunogenicity of a Heroin Vaccine and its Efficacy Against Morphine Challenge. | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | HENRY M. JACKSON FDN FOR THE ADV MIL/MED | MATYAS, GARY R | Bethesda, MD | 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: In order to address the opioid crisis, this group has developed a candidate heroin/opioid vaccine that induces antibodies that bind heroin/opioid upon injection and subsequently prevent the drug from crossing the blood-brain barrier and interacting with the brain's µ-opioid receptor. They completed pre-clinical testing of the vaccine candidate in mice and rats and demonstrated that the animals were protected from subcutaneous and intravenous heroin challenge. Ongoing durability studies have demonstrated that antibody titer and protective efficacy were maintained 6 months after the last vaccination. This project proposes to advance the development of the vaccine candidate by conducting a Phase I/IIa human clinical trial, by performing vaccine synthesis, nonclinical studies, and then a clinical trial. The supplemental award will allow for testing the efficacy of fentanyl haptens and of the combination heroin–fentanyl vaccine. |
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1R34DA050261-01
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3/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | ARKANSAS CHILDREN'S HOSPITAL RES INST | OU, XIAWEI (contact); ACHESON, ASHLEY | Little Rock, AR | 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: A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study. |
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3UG1DA013035-18S6
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Culturally Centered Medication for OUD (MOUD) Implementation Facilitation for Primary Care and Addiction Treatment Programs Serving American Indian/Alaska Natives | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | ROTROSEN, JOHN P; NUNES, EDWARD V. | 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: 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. |
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3R01DA041434-03S1
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IMPROVING ACCESS TO SUBSTANCE ABUSE EVIDENCE-BASED PRACTICES FOR YOUTH IN THE JUSTICE SYSTEM: STRATEGIES USED BY JPOS | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | Oregon Social Learning Center, Inc. | SHEIDOW, ASHLI J | Eugene, OR | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Justice-involved young adults are one of the highest-risk populations for the development of opioid use disorder (OUD) and other significant public health problems, but they usually lack access to evidence-based practices that could potentially prevent this trajectory. The risk of unintentional death and other deleterious outcomes and long-term costs for opioid misuse for young adults, their communities and society (costs estimated at more than $115 billion annually) make this a priority, with rural areas in need of the most attention and assistance. The overriding purpose of the proposed pilot study is to prevent the onset of OUD by improving young adult offenders’ access to evidence-based risk reduction interventions, like contingency management (CM), by testing whether officers in the adult probation and parole setting can deliver such an intervention to their young adult substance using probationers who have not yet developed OUD. The primary motivation for this pilot is the clear public health need for improving and expanding delivery of substance use risk reduction interventions for young adults in the justice system. The ultimate outcome would be prevention of OUD in this high-risk population. |
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3P50DA046351-02S1
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Center to Advance Research Excellence (OPTIC) | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | RAND Corporation | STEIN, BRADLEY | Santa Monica, CA | 2019 |
NOFO Title: NIDA Research Center of Excellence Grant Program (P50)
NOFO Number: PAR-16-009 Summary: The U.S. is in the midst of an opioid crisis, and efforts to tackle the complex and dynamic nature of this public health challenge must comprehensively consider a multitude of contributing factors. In response, states have implemented a wide range of policies and initiatives. However, the dynamic nature of the crisis and the speed with which different policy approaches are being implemented pose numerous challenges for researchers evaluating the effects of such efforts. These challenges stem in part from limited information regarding policy implementation; insufficient information about policy characteristics that may influence effectiveness; little consideration of how the chosen analytic method may influence findings, given simultaneous or concurrent implementation of multiple policies; and limited training on how to best communicate findings to policymakers. To address these challenges, the proposed Center for Opioid Policy Research (COPR) will serve as a national resource, fostering innovative and high-quality research in the opioid policy arena and developing and disseminating methods, tools and information to the research community, policymakers and the public. |
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75N95019D00013-0-759501900089-1
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Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | Emmes Corporation | VanVeldhuisen, Paul | Rockville, MD | 2019 |
NOFO Number:
Summary: For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. ED patients have a disproportionately high prevalence of substance use disorders and are at an elevated risk of overdose, and many do not access health care elsewhere. Despite this, OUD interventions are rarely initiated in EDs. The Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder study (CTN-0079) will assess the feasibility, acceptability and impact of introducing clinical protocols for screening for OUD, buprenorphine treatment initiation, and referral for ongoing treatment in ED settings with high need, limited resources and different staffing structures. This extension study will use the existing infrastructure to evaluate the adoption and sustainability of the clinical protocols introduced at each of the study sites and to identify factors influencing their diffusion and effectiveness. |