Opioid Use Disorder

Researchers are evaluating the use of transversus abdominis plane (TAP) block with different adjuvants to improve pain relief after laparotomy surgery. This study compares the addition of dexamethasone or dexmedetomidine to bupivacaine in patients aged 25 to 65 years with ASA Class I or II status. The goal is to assess which combination provides longer-lasting postoperative analgesia and reduces the need for additional pain medication. Participants will be randomly assigned to one of two groups. Group A receives a TAP block with 18ml of 0.25% bupivacaine plus 2ml of dexamethasone (8mg). Group B receives the same bupivacaine dose plus 2ml of dexmedetomidine (1µg/kg diluted in saline). The TAP block is administered bilaterally under ultrasound guidance immediately after surgery, using a needle guided between the internal oblique and transversus abdominis muscles. Patients are monitored for complications like local anesthetic toxicity or hematoma. During the 24-hour postoperative period, patients' pain levels will be measured using a Visual Analogue Scale (VAS) at several time points. If pain is insufficiently controlled (VAS ≥4), rescue analgesia with IV ketorolac will be provided and the time to first rescue dose recorded. Additional assessments include monitoring nausea, vomiting, heart rate, and blood pressure. The primary outcome is the duration until the first request for rescue analgesia, with secondary outcomes focused on pain scores over 24 hours.

This research aims to understand the views of teachers, parents, and students on preventing substance abuse among adolescents and to develop a school-based prevention program. The study evaluates the effectiveness of a bilingual, multicomponent training called the School-based Substance abuse Prevention Programme (SSPP) designed to improve awareness, attitudes, resistance to peer pressure, and life skills related to substance abuse prevention among adolescents aged 13 to 15 years in selected public schools of Pokhara, Nepal. The SSPP intervention includes four modules delivered to the experimental group: psychoeducation with video-assisted teaching and informational booklets to raise awareness; role play and case-based scenarios to foster positive attitudes and peer pressure resistance; storytelling on life skills like problem solving and emotion management; and demonstrations on communication, decision making, creative thinking, and stress management. The control group does not receive the intervention during the study but is given information booklets and video teaching after the posttest. Participants will be assessed at baseline, 3 months, and 6 months for changes in awareness, attitudes, peer pressure resistance, and life skills related to substance abuse prevention. Data collection involves focus group discussions for initial qualitative insights and cluster randomization of schools for the trial. The study includes 210 adolescents and tracks demographic factors and family history potentially related to substance abuse. The total study duration extends through these follow-up points to measure the program's impact.

This research aims to develop and test a brief, values-based treatment to support US Veterans with opioid use disorder (OUD) during early medication treatment. The study focuses on improving interpersonal functioning and community integration to enhance quality of life during the high-risk early recovery period. It will proceed in three phases: treatment development and adaptation, an open pilot with 10 Veterans, and a pilot randomized controlled trial comparing the new treatment to usual care with 40 Veterans. In Phase 1, the treatment manual is developed and revised using interviews with Veterans and VA providers. Phase 2 involves delivering the intervention in four weekly 50-minute sessions to 10 Veterans receiving buprenorphine, refining the manual and study procedures based on feedback. Phase 3 randomizes 40 Veterans to either the new intervention or treatment as usual, with the intervention delivered by trained clinical psychology fellows and usual care including case management and group therapy. Participants will attend assessments at baseline, post-treatment (6 weeks), and follow-ups at 3 and 6 months. Assessments include measures of interpersonal functioning, community reintegration, quality of life, substance use, and treatment adherence. Sessions and assessments may be in-person or remote, with independent evaluators conducting assessments. Therapist adherence and competence will be monitored. The study will track treatment attendance, participant satisfaction, and feasibility outcomes over approximately six months per participant.

Opioid overdose deaths have reached record highs in the United States, especially among patients discharged from emergency departments (ED). This research aims to evaluate a bundled intervention combining telehealth, peer support, buprenorphine treatment, and linkage to addiction programs to increase treatment uptake, reduce repeat opioid overdoses, and lower mortality in patients with opioid use disorder (OUD) after ED discharge. The study is supported by the HEAL Initiative and focuses on patients with recent opioid overdoses who face barriers to treatment after leaving the ED. The study includes two phases. In phase 1, 30 patients discharged from the ED will receive daily peer support via telehealth during the first week, then less frequently over 12 weeks, alongside buprenorphine prescribed by physicians. In phase 2, about 160 participants will be randomized to either the same bundled intervention or usual care, which includes ED-initiated buprenorphine and referral lists but no ongoing peer support. The intervention lasts 3 months post-ED discharge, and participants in all groups will complete follow-up surveys at 1 and 3 months. Participants will be involved in baseline assessments, receive the intervention or usual care after ED discharge, and complete self-report questionnaires through electronic surveys at 1 and 3 months. Peer supporters will remind participants to complete surveys. The study will measure treatment retention, adherence to buprenorphine, and successful linkage to addiction treatment programs at 1 and 3 months after ED discharge. These outcomes will help assess the feasibility and impact of this bundled approach to reduce opioid overdose risks and improve care continuity.

Researchers are evaluating two forms of buprenorphine—sublingual tablets versus a long-acting injectable—to treat opioid use disorder in adults who use fentanyl or other strong synthetic opioids. The study aims to compare how often participants use drugs and experience relapse after starting either treatment. It also explores how factors like body fat, weight, fentanyl use before treatment, blood levels of buprenorphine, cravings, and withdrawal symptoms affect treatment outcomes. Participants will begin treatment during a brief overnight hospital stay, where they receive either a single dose of sublingual buprenorphine/naloxone followed by the injectable or standard sublingual buprenorphine/naloxone titration. Blood and urine samples will be collected during the hospital stay and follow-up visits. These visits occur at 1, 2, 3, and 4 weeks after leaving the hospital to monitor drug use, cravings, withdrawal, quality of life, and physical health. Throughout the study, participants will provide samples and attend in-person follow-ups to assess their progress and treatment effects. Researchers will measure the percentage of days participants remain abstinent from opioids and rates of sustained relapse during the 4-week follow-up. They will also evaluate withdrawal severity and dropout rates during the initial inpatient period. The total participation time includes the inpatient stay plus 4 weeks of follow-up visits.

Researchers are evaluating the pharmacokinetic profiles, safety, and tolerability of two investigational drugs, IVL3004 and IVL4002, compared to Vivitrol (Naltrexone) Long-Acting Injectable. This phase 1, open-label study involves healthy adult male volunteers aged 18 to 55 years. The purpose is to explore how these drugs behave in the body when given as single ascending doses and to assess any safety concerns. The study consists of multiple groups receiving single doses of either Vivitrol via intramuscular injection or varying doses of IVL3004 and IVL4002 administered either intramuscularly or subcutaneously. Participants will receive these injections in a fixed sequence to compare the pharmacokinetic properties of each drug. Participants will undergo assessments from before dosing up to day 57, including measurements of drug concentration over time (AUC and Cmax). They will be monitored for safety and tolerability through physical exams, laboratory tests, and observation for adverse effects. The total study participation spans several weeks with follow-up visits to collect data on how the drugs are processed in the body and any side effects experienced.

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

Researchers are evaluating a new type of cell therapy called autologous chimeric antigen receptor T (CAR-T) cells that target CD19, CD22, and BCMA in patients with relapsed or refractory multiple myeloma. This early-phase, open-label study aims to assess the safety and tolerability of this treatment and to find the highest dose that patients can safely receive. Additional goals include studying how the therapy behaves in the body, how long the CAR-T cells survive, and its effects on the disease. Participants will go through several phases including screening, collection of their immune cells (apheresis), a treatment to prepare their body (lymphodepletion), followed by a single intravenous infusion of the CAR-T cells. After the infusion, patients will be closely monitored for dose-limiting toxicities during the first 28 days and followed up for longer-term observations. The study uses a dose escalation approach to find the maximum tolerated dose. During the study, participants will have multiple assessments such as blood tests to measure the concentration and activity of CAR-T cells, immune markers, and signs of disease progression. Researchers will also track overall survival and progression-free survival over two years. Safety and response will be evaluated frequently from the day of infusion through follow-up visits. The total participation duration may extend up to the end of the study, which is expected in late 2027.

Opioid overdose causes significant global health problems, and while prevention and treatment programs exist, more efforts are needed to reduce deaths and complications. This research evaluates a novel smartphone-based volunteer first responder system integrated with national emergency call services to assist suspected opioid overdoses. The system aims to alert trained volunteers equipped with naloxone, an opioid antidote, to provide early treatment before emergency medical services arrive, potentially saving lives by reducing the time to naloxone administration. Volunteer responders, called naloxone-responders, will complete training in opioid overdose recognition, naloxone use, and first aid based on European and Swedish guidelines. They will also learn low-arousal communication techniques for interacting with overdose victims. Each responder receives a kit with two doses of nasal naloxone and will be registered on a dedicated responder smartphone app. The study includes a two-year pilot phase with one-year follow-up per participant, along with multiple sub-studies examining feasibility, safety, acceptability, mortality, and experiences of responders and overdose survivors. Participants will be monitored through questionnaires, app data, and medical records from dispatchers, paramedics, and hospitals. The primary outcomes include the number of successful naloxone responder alerts, responder acceptability, clinical outcomes of overdose victims, and safety experiences during alerts. Mortality rates before and after the trial will also be analyzed. The study runs from September 2025 to August 2027, assessing both short- and long-term effects of integrating volunteer responders with emergency medical dispatch.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 given by intravenous infusion in healthy adults aged 18 to 55. This study involves a fentanyl challenge combined with naloxone blockade to assess how CS-1103 interacts with these drugs. The study is a randomized, double-blind, placebo-controlled Phase 2 trial sponsored by Clear Scientific, Inc., focusing on fentanyl overdose and poisoning scenarios. Participants receive naloxone (400 mcg IV) first, followed by fentanyl (200 mcg IV), and then either CS-1103 (1,000 mg IV) or a placebo (saline) infusion. The trial compares the effects of CS-1103 against placebo under these controlled drug administration conditions. The study includes a single dose of the investigational drug administered intravenously after fentanyl and naloxone. During the study, participants are closely monitored for adverse events through physical exams, ECGs, vital signs, and laboratory tests over a period of three days plus a follow-up on Day 10. Blood and urine samples are collected for up to 48 hours to measure CS-1103 and fentanyl levels. The trial also evaluates the impact of CS-1103 on QT intervals and naloxone pharmacokinetics. Total participation lasts through these monitoring and follow-up periods to ensure safety and gather efficacy data.