Substance 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 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.

Researchers are evaluating the use of psilocybin, a 5-HT2A receptor agonist, for helping adults with tobacco use disorder quit smoking. This phase 2, multi-site, double-blind, randomized clinical trial involves 66 participants across four experienced research sites. The study aims to compare psilocybin with niacin, an active placebo, both combined with cognitive behavior therapy CBT, to assess smoking cessation effectiveness and related cognitive changes over 12 months. Participants will be randomly assigned to receive either oral psilocybin or oral niacin in two sessions spaced one week apart. Psilocybin doses are 30 mg in the first session and either 30 mg or 40 mg in the second, depending on responses to a mystical experience questionnaire. Niacin doses are 150 mg in the first session and either 150 mg or 200 mg in the second, following the same dosing schedule. Both groups receive CBT alongside the medication sessions to support quitting smoking. During the study, participants will undergo assessments including cognitive control tasks and questionnaires about smoking urges at screening and shortly after a target quit date. Smoking abstinence will be biochemically confirmed and measured for up to 12 months. Safety and health status will be monitored through interviews, physical exams, ECGs, and lab tests. The trial also investigates psychological factors that may influence quitting success, with overall participation lasting about one year.

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 two brief interventions aimed at addressing potentially problematic cannabis use in emerging adults aged 18 to 25. Cannabis is widely used among this age group, and frequent use may lead to long-term health, social, and academic or occupational challenges. The study seeks to assess the feasibility, acceptability, and early effectiveness of a novel cannabis brief intervention compared to a health education approach, using rigorous methods to improve intervention quality for this population. The study involves two groups receiving different 2-session brief interventions, each session lasting 40 to 50 minutes and separated by about one week. One group receives health education focusing on sleep hygiene, nutrition, physical activity, stress, and social connection. The other group participates in the Bloom intervention, which includes personalized discussions about values, reasons for cannabis use, and strategies for living in line with personal goals. Participants are randomly assigned to one of these interventions. Participants complete detailed cannabis assessments including biological samples and self-report measures at baseline, immediately after the second session, and at 1-, 3-, and 6-month follow-ups. Saliva samples are collected five times to test for THC and CBD levels. Researchers measure cannabis use patterns, problems related to use, and symptoms of cannabis use disorder. The total participation period extends up to 6 months post-intervention, with regular assessments to monitor changes and safety throughout the study.

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.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

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.