Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R01HD096798-01
SAFETY, PHARMACOKINETICS AND EFFICACY OF EXTENDED-RELEASE NALTREXONE IN PREGNANT WOMEN WITH OPIOID USE DISORDER Enhanced Outcomes for Infants and Children Exposed to Opioids NICHD Boston Medical Center WACHMAN, ELISHA Boston, MA 2018
NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036
Summary:

Opioid use disorders (OUDs) in pregnancy are a U.S. public health crisis; the current standard of care is treatment with an opioid agonist such as buprenorphine (BPH), which has an associated risk for neonatal abstinence syndrome (NAS) and possible long-term neurodevelopmental consequences. As a novel treatment option for OUD in pregnancy, naltrexone would not expose the developing fetus to opioids, greatly reducing the risk for NAS and potentially improving maternal and infant outcomes. This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with OUDs, evaluating comprehensive mother-infant outcomes throughout the pregnancy and first year after birth. It will enroll 50 pregnant women stabilized pre-pregnancy on extended-release naltrexone (XR-NTX) and 50 comparison women on BPH from Boston Medical Center and the University of North Carolina in this multi-center prospective comparative cohort study.
3U01MH114087-02S2
EVALUATING THE IMPACT OF CHANGES IN OPIOID PRESCRIBING ACROSS HEALTH SYSTEMS IMPLEMENTING ZERO SUICIDE New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIMH Henry Ford Health System AHMEDANI, BRIAN KENNETH; SIMON, GREGORY E. DETROIT, MI 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 supplement supports the goals of the current award, “An Evaluation of the National Zero Suicide Model Across Learning Healthcare Systems” (U01MH114087). Safety planning is a highly recommended practice within the Zero Suicide framework, but little is known about the effectiveness of the individual elements that can make up a safety plan, such as lethal means assessment, identification of supportive contacts, coping skills, warning signs, and sources of distraction. All of the documentation lives in text-based clinical narratives. This supplement will support development of new metrics using natural language processing to determine baseline rates, from which we can quantify the change in safety planning and lethal means assessment practice longitudinally after implementation of new safety planning templates using our Zero Suicide main award.
1R01HD096796-01
PHARMACOLOGICALLY-BASED STRATEGIES FOR BUPRENORPHINE TREATMENT DURING PREGNANCY Enhanced Outcomes for Infants and Children Exposed to Opioids NICHD Magee-Women's Research Institute and Foundation CARITIS, STEVE N Pittsburgh, PA 2018
NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036
Summary:

This study will challenge current clinical approaches to managing the pregnant woman with opioid use disorder. Dosing of buprenorphine (BUP) in pregnant women is based on studies in non-pregnant subjects, which suggests that symptoms of withdrawal occur when plasma BUP concentrations are < 1ng/ml. No such data exist for pregnant women, but this is a prerequisite for defining an appropriate dosing regimen of BUP in pregnant women. We will define this threshold by monitoring women undergoing mild, medically directed withdrawal. The Clinical Opioid Withdrawal Scale score and the Finnegan score for NAS are key to defining when withdrawal occurs and thus dictate treatment in mother and baby. Neither scoring system is based on plasma BUP concentrations and thus, may not reflect true opioid withdrawal. This proposal aims to develop physiologic-based scoring systems that refine the accuracy of diagnosis and optimize treatment.
1R21AT009932-01
MINDFUL BODY AWARENESS TRAINING AS AN ADJUNCT TO MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER New Strategies to Prevent and Treat Opioid Addiction NCCIH University of Washington PRICE, CYNTHIA J; MERRILL, JOSEPH O SEATTLE, WA 2018
NOFO Title: Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-001
Summary:

This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD.
3U01DE025633-03S1
INVESTIGATION AND MODULATION OF THE MU-OPIOID MECHANISM IN CHRONIC TMD (IN VIVO) Preclinical and Translational Research in Pain Management NIDCR UNIVERSITY OF MICHIGAN AT ANN ARBOR DASILVA, ALEXANDRE ANN ARBOR, MI 2018
NOFO Title: Biology of the Temporomandibular Joint in Health and Disease (R01)
NOFO Number: PA-14-358
Summary:

Initial studies using positron emission tomography (PET) with [11C] carfentanil, a selective radiotracer for ?-opioid receptor (?OR), have demonstrated that there is a decrease in thalamic µOR availability (non-displaceable binding potential BPND) in the brains of TMD patients during masseteric pain compared to healthy controls. ?-opioid neurotransmission is arguably one of the mechanisms most centrally involved in pain regulation and experience. The main goals of our study are: first, to exploit the ?-opioidergic dysfunction in vivo in TMD patients compared to healthy controls; second, to determine whether 10 daily sessions of non-invasive and precise M1 HD-tDCS have a modulatory effect on clinical and experimental pain measures in TMD patients; and third, to investigate whether repetitive active M1 HD-tDCS induces/reverts ?OR BPND changes in the thalamus and other pain-related regions and whether those changes are correlated with TMD pain measures.