View clinical trials related to Opioid-Related Disorders.
Filter by:The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: - Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. - To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment. In this study participants will: - Receive two placental-fetal MRIs, one during second trimester and one in third trimester. - Answer surveys relating to their medical and social history. - Have blood drawn during pregnancy and delivery. - Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.
The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years. To do this, the implant containing the drug will be inserted under the skin, left in place for 3 months and then removed.
This project seeks to address the overdose epidemic by working with overdose fatality review (OFR) teams. Current OFR practices rely on a case review model where OFR teams assess one or two overdose cases to make policy and program recommendations. However, the continued rise in overdose rates and number of preventable overdose deaths suggest a need to shift OFR teams away from case review and toward using timely population-level data to better inform their recommendations and actions. The goal of this project, Fatal Overdose Review Teams - Research to Enhance Surveillance Systems (FORTRESS), is to improve standard OFR practices by equipping OFRs with a data dashboard built on near real-time aggregate data, linked across multiple sources and presented in a way that helps identify common "overdose touchpoints," or opportunities to connect individuals at risk for overdose with evidence-based treatment. During the first project phase, the FORTRESS team will design the "Overdose Touchpoints Dashboard'' (Aim 1). The FORTRESS team will also train OFR team members in "Data-Driven Decision Making" (DDDM) to effectively use the dashboard. The FORTRESS team also includes individuals involved in developing the CDC's OFR best practice guidelines and a pilot study of OFR adherence to these guidelines, which will inform the FORTRESS team's development of an "OFR Fidelity Tool'' (Aim 2). This tool will be the first of its kind. For the second project phase, the FORTRESS team will conduct a cluster-randomized stepped-wedge trial comparing the impact of the intervention (dashboard + DDDM training) versus standard OFR practices on both implementation (Aim 3) and effectiveness outcomes (Aim 4). Implementation outcomes include implementation process fidelity (Stages of Implementation Completion), staff acceptance of harm reduction philosophies (qualitative interviews), OFR fidelity to CDC best practices (FORTRESS OFR Fidelity Tool), and usability of the Overdose Touchpoint Dashboard, (Systems Usability Scale). A statewide OFR data repository serves as a rich source of data on effectiveness outcomes, including OFR team recommendation quality and local actions to implement recommended overdose prevention strategies. The FORTRESS team will also survey OFR team members to assess changes in their attitudes toward evidence-based overdose prevention strategies. In sum, the FORTRESS team is uniquely qualified to help OFRs use more comprehensive available data to inform quality, action-oriented recommendations to reduce overdose.
The study investigates long-term opioid treatment in patients with chronic non-cancer pain (CNCP). The study aims to prospectively identify predictive factors for work ability and for developing opioid use disorder (according to DSM-5) as well as predictive factors for pain, activity, and health-related quality of life. It is hypothesized that certain biopsychosocial factors mapped in this study predict patterns of opioid use and the risk for developing OUD for patients with CNCP on long-term opioid therapy. Further, it is hypothesized that certain biopsychosocial factors mapped in this study predict the chance of improved work ability and other treatment benefits of long term opioid therapy in patients with CNCP.
The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.
The purpose of this study is to investigate the impact of a pharmacist-led intervention to expand access to medications for opioid use disorder (MOUD) on racial/ethnic differences in opioid-related overdose among individuals diagnosed with opioid use disorder (OUD) currently incarcerated in a carceral setting. In this study, participants will be screened for opioid use, trained to administer Narcan nasal spray, receive motivational counseling and referral to treatment post-release from a carceral setting (a Re-Entry program) into the community.
Microdosing induction is a novel method of starting buprenorphine/naloxone without patients experiencing the opioid withdrawal that is a part of traditional induction. Patients take small doses of buprenorphine/naloxone that increase slowly over a week. Although microdosing induction has been supported anecdotally, its effectiveness is not known. The proposed study will compare the effectiveness and safety of two induction strategies for transitioning patients from opioids to buprenorphine/naloxone. All inductions will occur in an outpatient telehealth opioid use disorder (OUD) treatment setting. The study will compare patients who receive traditional induction versus microdosing induction. Primary outcomes include effectiveness and safety. Secondary outcomes include treatment retention, self-reported use of opioids during induction, return to opioid use, opioid appearance in drug screens, craving/withdrawal symptoms, and patient satisfaction.
This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE; ClinicalTrials.gov Identifier: NCT05053503). Clinical outcome scores will be collected at study exit from protocol SBM-OWP-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol SBM-OWP-03.
Performance measure can improve quality of care at the patient, provider, and systems level of care, and patient-reported outcome measures bring a needed patient-centered focus. Recovery has been difficult to measure for people with substance use disorders, and is more challenging in the context of opioid use disorders (OUD) and treatment medications. This study will examine a recovery patient-reported outcome measure to determine if patients and clinicians find it useful and acceptable in the clinical context, and if it leads to improved outcomes.