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 (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 conducting a multi-site, double-blind, randomized clinical trial to study the effects of the 5-HT2A receptor agonist psilocybin compared to niacin for helping adults with tobacco use disorder to quit smoking. This Phase 2 study addresses prior findings from an open-label pilot trial and aims to include a diverse sample across four research sites to better evaluate psilocybin's potential efficacy in smoking cessation. Participants will receive two sessions one week apart of either oral psilocybin (30 mg in the first session and either 30 mg or 40 mg in the second session based on their response) or oral niacin (150 mg in the first session and either 150 mg or 200 mg in the second session). Both groups also receive cognitive behavioral therapy (CBT) to support quitting smoking. Niacin serves as an active placebo to help maintain study blinding. During the study, participants will undergo screenings including medical exams, blood tests, ECG, and smoking assessments. Researchers will measure biologically-verified abstinence rates up to 12 months and assess cognitive control and smoking urges at multiple time points before and after the target quit date. Safety monitoring and adherence to abstaining from smoking and psychoactive drugs around dosing sessions are included. The total study participation duration spans up to 12 months with follow-up to evaluate smoking cessation outcomes.

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.

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.

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 conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

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.