Alcohol Use Disorder

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 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 evaluating the effectiveness of a combined neurofeedback and transcranial magnetic stimulation (TMS) intervention for individuals receiving treatment for Alcohol Use Disorder. This study aims to assess how these techniques may influence alcohol use, craving, community functioning, employment status, aggression, antisocial behavior, and brain activity over time. Participants will be randomly assigned to one of several groups receiving four weekly sessions of different combinations of active or sham TMS and neurofeedback using fMRI. The TMS involves 10 Hz pulses delivered to the right dorsolateral prefrontal cortex. Neurofeedback sessions provide real-time brain activity information either from the participant or others. A control group will receive typical treatment without TMS or neurofeedback. Participants will attend an initial visit followed by weekly intervention sessions for four weeks. Monthly remote follow-ups will occur for up to 12 months, with MRI follow-ups at 6 and 12 months. Researchers will measure changes in alcohol use, craving, social and employment outcomes, behavior, and brain structure and function throughout the study period. Safety and adherence will be monitored continuously.

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.

Researchers are studying the safety, tolerability, and how the body processes the investigational drug CMND-100 in both healthy volunteers and people with Alcohol Use Disorder (AUD). The study also aims to explore if CMND-100 can help reduce drinking and craving in those with moderate to severe AUD. This is a Phase I/II trial with multiple parts to carefully evaluate these factors. The study is divided into four parts. Parts A and B involve giving single ascending doses of CMND-100 to healthy volunteers and subjects with AUD, respectively, to assess safety and drug behavior. Parts C and D are randomized and double-blind, where participants receive either CMND-100 or placebo daily for five days to further evaluate safety, drug effects, and preliminary efficacy. Each part includes careful dose escalation guided by a monitoring board. Participants will undergo physical exams, blood sampling for drug levels, and daily safety monitoring during and after dosing. Assessments include observing adverse events and measuring drug concentration in the body up to 31 days. For subjects with AUD in Part D, craving for alcohol will be assessed using specific craving scales. The total involvement includes dosing days and follow-up for safety and pharmacokinetic analysis, lasting up to several weeks.

Researchers are developing and testing a culturally adapted mobile health application aimed at Black individuals who engage in hazardous drinking and experience clinical anxiety. This study evaluates a personalized feedback intervention (PFI) designed to increase knowledge about the harmful relationship between anxiety and alcohol use, motivate reduction in risky drinking, and change attitudes towards anxiety-related alcohol consumption. The intervention is delivered through a brief, single-session mobile application available on Android and iOS platforms. Participants complete a 45-minute session at the start and then have access to the app's materials for up to three months. The app was created with expert input and usability testing from Black hazardous drinkers with clinical anxiety to ensure cultural relevance and ease of use. Participants will take part remotely, with initial screening and baseline assessments conducted via Zoom. Follow-up data will be collected remotely at one week, one month, and three months after the intervention. Researchers will measure changes in alcohol use, anxiety severity, motivation to reduce drinking, drinking motives, and alcohol attitudes to assess the app’s feasibility, acceptability, and initial effects.

Researchers are evaluating two approaches to deliver brief interventions aimed at people whose Alcohol Use Disorders Identification Test (AUDIT) scores indicate potentially unhealthy alcohol use. This study compares the effectiveness of an electronic brief intervention (eBI) delivered via an app on a handheld device with a traditional face-to-face brief intervention conducted by trained health educators. The study is designed as a non-inferiority trial to determine if the electronic method is at least as effective as the in-person approach in reducing alcohol consumption and related risky behaviors. Participants will be randomly assigned by week to receive either the electronic brief intervention through an app or the traditional in-person brief intervention. The interventions provide personal feedback on drinking risk levels and guidance to develop realistic plans to reduce alcohol consumption. The study is conducted in hospitals and clinics in Zacatecas, Mexico, and Alexandra Township, South Africa, involving patients who score 8 or higher on the AUDIT and have not been screened in the past six months. Participants will complete an initial alcohol screening and a brief survey including demographic and alcohol use questions. Follow-up surveys will be completed at 3 and 6 months to monitor changes in alcohol consumption patterns. The main outcomes measured include average daily quantity and frequency of alcohol consumption within the last 30 days, along with other related measures such as maximum drinking quantity, frequency of heavy drinking episodes, and total AUDIT scores. Incentives are provided for survey completion, and contact information is collected to facilitate follow-up.

Researchers are evaluating whether a new blood biomarker can help identify depression and schizophrenia in patients attending psychiatric clinics. The study aims to see if changes in this biomarker can distinguish depressed patients who respond to treatment from those who do not, and differentiate individuals having a first psychotic episode from those at risk of developing schizophrenia. This observational study involves up to 500 participants grouped by diagnosis into Depression (DEP) and Psychosis/Schizophrenia (PSY) arms. Participants will attend three study visits over six months, during which blood samples and standard mental health assessments will be collected. These visits will help researchers analyze the relationship between the biomarker characteristics and the mental health conditions. The study does not involve any treatments but focuses on monitoring and measuring the biomarker and clinical factors over time. During the study, participants will complete standardized mental health questionnaires at each visit, and researchers will collect blood samples to study the biomarker changes. The main outcomes measured include the relationship between depression or psychotic disorders and biomarker characteristics over the six-month period. Researchers will also explore how clinical and demographic factors relate to these biomarker changes. The total participation time spans about six months with three scheduled visits.