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 1gkg 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 programs 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 Beggs 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.

This research aims to study cocaine use disorder CUD, a chronic condition with frequent relapses and abstinence periods. Researchers are evaluating brain dopamine release triggered by amphetamine using special PET scans in people with CUD. The study also looks at brain receptor changes related to stress and relapse, focusing on nociceptin opioid peptide receptors NOP and their role in counteracting stress effects in the brain. Understanding these mechanisms may help develop medications to prevent relapse in CUD. Participants will undergo a baseline PET scan using the radiotracer C-11NPA, followed by an oral dose of d-amphetamine at 0.5 mgkg. After amphetamine administration, a second PET scan will measure dopamine release in the brains striatum region. This study builds on previous imaging of NOP receptors before and after a hydrocortisone challenge and will explore how dopamine release relates to NOP receptor expression. The trial uses a single group design without masking. During the study, participants will have PET scans before and 2.5 to 3 hours after amphetamine intake to measure changes in dopamine binding. Researchers will assess dopamine release as their main outcome, focusing on changes in binding potential in the brain. Participants must meet strict health and substance use criteria, and safety monitoring includes screening for medical conditions and medication use. The study duration extends until September 2028, with comprehensive evaluations to understand the brain chemistry behind addiction and relapse.

Researchers are evaluating a brief, values-based behavioral intervention to support Veterans with opioid use disorder OUD who are in early buprenorphine treatment. The goal is to improve interpersonal functioning, community reintegration, and quality of life during early medication treatment. The project follows the NIH Stage Model for Behavioral Intervention Development and includes phases for treatment development, pilot testing, and a pilot randomized controlled trial. The intervention consists of four weekly 50-minute sessions focused on values clarification, understanding the connection between values and addiction treatment engagement, addressing barriers and goal setting, and planning recovery. Phase 1 develops and refines the manual using interviews with Veterans and providers. Phase 2 tests the intervention in an open trial with 10 Veterans to refine the treatment and study procedures. Phase 3 involves a pilot trial with 40 Veterans receiving the finalized intervention, assessing feasibility and preliminary effects. Participants will engage in scheduled assessments at baseline, post-treatment, and follow-ups at 3 and 6 months. Assessments include measures of interpersonal functioning, social support, quality of life, substance use, and treatment adherence. Study therapists adherence and competence will be monitored. Data will be securely managed, and participant feedback will guide further refinements. The study period spans multiple years, supporting treatment development and evaluation.

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 buprenorphinesublingual tablets versus a long-acting injectableto 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 buprenorphinenaloxone followed by the injectable or standard sublingual buprenorphinenaloxone 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 interventions impact on recovery and treatment adherence.