Funded Projects

NOFO Title: Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional)
NOFO Number: PAR-18-701

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
Summary:

New Hampshire can anticipate as many as 1,000 infants born with prenatal opioid exposure each year. Pain management is complicated for pregnant women with opioid use disorder (OUD), and undermanagement of pain is a strong risk factor for relapse. Contemplative interventions, such as yoga and mindfulness, may reduce risks for relapse for pregnant and parenting women with OUD. This project represents a partnership with New Hampshire stakeholders to develop and pilot evaluation of a trauma-informed yoga and mindfulness relapse prevention intervention (Mindful Moms in Recovery: MMORE). It aims to: 1) identify needs and areas of adaptation of trauma-informed yoga and mindfulness-based relapse prevention protocols through formative work with pregnant and parenting woman; 2) develop an integrated 10-session intervention protocol with iterative feedback from client stakeholders; and 3) evaluate feasibility, acceptability, and efficacy trends of MMORE in a pre-post pilot with pregnant women.

NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional)
NOFO Number: RFA-HL-19-029
Summary:

Chronic pain and opioid use disorders (OUD) are burgeoning interrelated epidemics. Sleep disturbances are prevalent, treatable, and increasingly recognized as risk factors for both chronic pain and OUD. Sleep disruption impairs endogenous pain inhibition, linked to analgesic efficacy and rewarding properties of mu-opioid receptor (MOR) agonists. It is not known, however, whether sleep disturbance causally alters mechanisms that contribute to OUD risk. Sleep continuity disruption (SCD) and/or sleep fragmentation (SF) may alter cerebral MOR availability, and these forms of sleep disruption may increase OUD risk. This study aims to 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked MOR binding potential (BP) in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response; and 3) determine whether MOR BP in brain regions of interest are associated with analgesia and abuse liability.

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

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.

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

The Family School Partnership (FSP) and classroom-centered (CC) interventions targeted aggressive-coercive behavior and poor academic achievement as antecedents of the distal outcomes of antisocial behavior, substance abuse/dependence, psychiatric symptoms/disorders, high-risk sexual behavior and successful adaptation to the relevant developmental demands of the educational, work, romantic relationships and family (both family of procreation and origin/orientation) social fields/contexts. The participants of the FSP and CC original prevention trial were a population (n = 798) of urban, predominately African-American young adults, who began first grade in the fall of 1993 in nine elementary schools in predominantly low- to lower-middle-income Baltimore areas. The central purpose of the proposed study is to extend through ages 31-35 an examination of normal and pathogenic development and the impact of these two universal first-grade preventive interventions on the distal targets mentioned above. We will continue to study the role of phenotypic and genetic factors (and their interactions) as well as the impact of the interventions on the development and course of substance use/abuse/dependence, psychiatric symptoms/disorders, antisocial behavior/disorder and high-risk sexual behavior through young adulthood. The knowledge accrued over the course of the proposed assessments should serve to inform the nature, targets and timing of our future preventive intervention efforts.

NOFO Title: Interventions for Youth who Misuse/Abuse Prescription Stimulant Medications in High School and/or College-Attending Youth (U01)
NOFO Number: RFA-DA-15-010

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:

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.

NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Profound sleep disturbances during abstinence have long been suspected of perpetuating vulnerability to relapse of people who misuse or are addicted to opioids. An animal model has shown that long-term sleep deficiency results in a persistent state of physiological dysregulation that is expected to modify the biology of abstinence and increase relapse potential. This study seeks to discover how persistent sleep restriction during withdrawal from opioid use increases vulnerability to relapse in the animal model by testing whether persistent sleep restriction during abstinence from opioid use is sufficient to increase opioid drug seeking. The functional outcome measure will be the degree of mitigation of opioid seeking. These studies will provide a basis for novel translational approaches to target mechanisms that are demonstrated to cause increased vulnerability to relapse.

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
Summary:

This study proposes to test the delivery of a comprehensive cognitive behavioral therapy, reSET, to determine whether it can improve treatment adherence and long-term outcome among patients with opioid use disorder initiating medication-assisted treatment within a community-based"Hub and Spoke” Model of buprenorphine maintenance in central Pennsylvania. reSET (Pear Therapeutics, Inc.) is a commercially available version of the web-based Therapeutic Education System (TES) delivered as a mobile app and recently approved by the FDA as the first digital therapeutic adjunct for the treatment of substance use disorders. Through a series of interactive therapy lessons, the program teaches patients cognitive-behavioral coping skills to resist drug use and to address factors such as craving, depression, and other mood problems and relationship issues that are associated with risk of relapse. The CM component provides concrete rewards contingent on performance of key target behaviors.

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.

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.