Drug Addiction

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.

Researchers are studying how bite force and bone turnover markers change during the retention phase after orthodontic treatment in patients with different vertical facial growth patterns. The study compares patients with vertical (hyperdivergent) and horizontal (hypodivergent) craniofacial growth to understand relapse and bone remodeling processes over a 12-month retention period. This prospective clinical trial aims to provide insights into maintaining teeth alignment using retention appliances after fixed orthodontic treatment. The trial includes two groups of patients who have completed fixed orthodontic treatment and are ready for retainer delivery. Group 1 consists of patients with vertical growth patterns (FMA 26° or more), while Group 2 includes those with horizontal growth patterns (FMA 24° or less). Both groups will receive a Begg's retainer formed conventionally and delivered within 24 hours of debonding. Changes in bite force will be measured using a bite force device, and bone turnover markers CTX (bone resorption) and BALP (bone formation) will be assessed using ELISA at baseline and at 1, 3, 6, and 12 months after retainer delivery. Participants will undergo bite force measurements and biomarker testing at five timepoints during the 12 months retention phase: at retainer delivery, then after 1, 3, 6, and 12 months. Data on bone turnover markers and bite force changes will be collected and compared between the two groups. The study includes monitoring of functional occlusion, oral hygiene, and retainer compliance. The total participation time spans 12 months, during which researchers will assess both clinical and biochemical indicators of bone remodeling and bite function after orthodontic treatment.

Researchers are investigating cocaine use disorder (CUD), a chronic condition marked by frequent relapses and abstinence periods. This early phase 1 study aims to understand the brain's chemical changes related to stress and relapse by examining dopamine release after amphetamine use and its link to the nociceptin opioid peptide receptor (NOP) system, which helps counteract stress effects in the brain. The study explores how this system may fail in people with CUD, potentially leading to relapse. Participants will undergo a series of scans and drug challenges. They will first have a baseline [C-11]NPA PET scan to measure brain receptor activity, followed by oral administration of d-amphetamine at 0.5 mg/Kg to stimulate dopamine release. After 2.5 to 3 hours, a second [C-11]NPA PET scan will be performed to observe changes in dopamine activity. This imaging approach helps link brain receptor expression to dopamine release in relevant brain regions. Throughout the study, participants will be closely monitored with PET scans before and after amphetamine administration. Researchers will measure changes in dopamine receptor binding potential to evaluate brain responses. Additional eligibility requirements include medical history reviews, physical exams, and ensuring no interfering medications or conditions. The primary outcome is the change in binding potential relative to non-displaceable uptake measured at baseline and post-amphetamine, with follow-up planned over twelve weeks to relate findings to relapse risk.

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.

This research aims to evaluate a digital intervention called Enhearten designed to reduce self-stigma and improve substance use disorder (SUD) treatment and recovery outcomes among pregnant and postpartum women (PPW) with SUDs. The study will test how feasible, acceptable, and effective Enhearten is in supporting adherence to medications for addiction treatment (MAT) while addressing the unique challenges and stigma faced by PPW. This trial is a randomized controlled study conducted at multiple centers to examine these effects over time. Participants will be randomly assigned to one of two groups: one group will use the Enhearten digital intervention with a stigma-focused ecological momentary intervention (EMI) that screens for feelings of stigma and provides just-in-time support, while the other group will be on a waitlist and receive access to Enhearten after the trial. Enhearten is tailored to encourage treatment retention and reduce self-stigma specifically for pregnant and postpartum women, adapting its features to their needs. During the study, participants will be monitored from baseline through six months after the intervention for changes in self-stigma and internalized stigma related to substance use. Researchers will also track medication use for addiction treatment, substance use and cravings, attitudes and self-efficacy towards treatment, mental health symptoms, and infant feeding intentions. The study will collect data on the usability and acceptability of the intervention from one to six months post-intervention. Overall participation will involve regular assessments to measure these outcomes and understand the intervention's impact on recovery and treatment adherence.