Cocaine 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 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 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 evaluating treatments for patients with colorectal cancer who experience early relapse within one year after completing adjuvant chemotherapy with XELOX or FOLFOX. These patients have a poor prognosis, limited treatment options, and most have tumors resistant to immune checkpoint inhibitor monotherapy. This phase II randomized trial aims to assess the safety and effectiveness of adding serplulimab, a PD-1 inhibitor, to second-line chemotherapy plus targeted therapy in this high-risk group. Participants will be randomly assigned to one of two groups: the experimental arm receiving serplulimab combined with FOLFIRI chemotherapy and targeted therapy, or the control arm receiving FOLFIRI plus targeted therapy alone. Treatment regimens vary based on tumor location and RAS mutation status, with cetuximab used for left-sided, RAS wild-type tumors and bevacizumab for right-sided, RAS mutant tumors. Serplulimab is administered intravenously every two weeks at 3 mg/kg. The study uses a Pick-the-Winner design to enroll 40 patients total. During the study, researchers will monitor progression-free survival over 12 months as the primary outcome. Secondary outcomes include objective response rate, disease control rate, overall survival over 36 months, and safety assessments using standard criteria. Exploratory analyses will examine tumor and blood biomarkers to identify predictors of response and resistance. Participants will undergo scheduled visits, treatments, laboratory tests, and assessments throughout the study period to evaluate these outcomes.

Researchers are evaluating the iDECIDE curriculum, a new drug education and diversion program, in about 300 middle and high school students who have recently broken school substance use rules. This randomized controlled trial aims to see if iDECIDE improves knowledge about drugs, attitudes toward substance use, and actual substance use behavior compared to a waitlist control group. The study focuses on adolescents' understanding of drug effects, brain development, and readiness to reduce or quit substance use. Participants will be randomly assigned to one of two groups: the iDECIDE group or a waitlist control group. The iDECIDE group will complete four weekly sessions of a drug education curriculum, delivered via videoconference or in-person, each lasting 60 to 75 minutes. This curriculum covers topics such as addiction neurobiology, brain development, industry tactics, and healthy alternatives. The control group will undergo symptom and substance use monitoring during the weekly visits and may choose to join the iDECIDE program after one month. The study involves nine visits over about one year, including baseline assessment, four weekly intervention or monitoring visits, and four follow-up visits at one week, one month, six months, and one year after the intervention. Participants will complete questionnaires, assessments, and urine tests at various visits, with raters blinded to group assignment. The study will measure knowledge of drug effects and brain development, frequency of substance use, readiness to quit, and perceptions of harm. Participants will receive compensation for attending sessions and providing urine samples.

Researchers are evaluating ways to improve well-being and child welfare outcomes among families at risk of substance misuse by engaging fathers in the Bronx and nearby communities. The study focuses on fathers who are custodial or non-custodial and aims to compare usual services with enhanced fatherhood engagement programs to support families facing substance use concerns. Participants will be randomly assigned to one of two groups: one receiving services as usual, and the other receiving enhanced services through a Regional Partnership Grant. Enhanced services include Motivational Enhancement to encourage substance abuse treatment engagement, participation in the HERO Dads fatherhood program to improve parenting skills, Contingency Management to support attendance and abstinence, and Case Management for referrals to treatment and resources. During the study, fathers and their families will be assessed at the start and after six months to measure child well-being and father engagement using various parenting and behavioral health scales. The study includes follow-ups to track changes in father involvement, mental health, and substance use, ensuring ongoing monitoring of outcomes over the study period.

Researchers are studying synaptic density in the brain by comparing individuals with cocaine use disorder (CUD) to healthy controls. This observational study aims to understand differences in brain function and structure related to cocaine use, using advanced imaging techniques. Participants include both healthy volunteers and those diagnosed with CUD, aged 21 to 60 years. Participants with CUD will stay as inpatients and undergo one MRI scan and two 11C-UCB-J PET scans, along with neurocognitive tasks. They will also complete sleep studies during their stay and attend outpatient follow-ups twice a week for up to nine weeks after discharge. Healthy controls will participate as outpatients, completing one MRI and one 11C-UCB-J PET scan and neurocognitive tasks. Throughout the study, researchers will assess brain regions including the anterior cingulate cortex, ventromedial prefrontal cortex, and medial orbitofrontal cortex. They will measure synaptic density, volume distribution, binding potential, and gray matter volume. Sleep studies and neurocognitive assessments will provide additional insights. Safety and health will be monitored with medical history, physical exams, and laboratory tests. The study is expected to continue until June 2026.

Researchers are evaluating the Bright Horizons program to see if it can reduce binge substance use among adolescents aged 12 to 17 who have recently engaged in binge drinking. This culturally adapted intervention was developed through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons focuses on teaching emotion regulation, coping skills, problem solving, and goal setting to help reduce alcohol and other substance use and connect youth with treatment resources. Participants are randomly assigned to either the Bright Horizons intervention group or a control group. Those in the intervention group receive one 2-4 hour session with a Research Program Assistant, while the control group receives standard case management through the White Mountain Apache suicide and self-harm surveillance system. After all intervention participants have been enrolled, control participants will also receive the Bright Horizons program. Throughout the study, participants complete assessments at enrollment, 4 weeks later, and again 4 weeks after that. These evaluations measure changes in alcohol use, coping with stress, impulsivity, family functioning, peer relationships, other substance use, and cultural identity. The primary outcome is change in alcohol use as recorded by the Timeline Followback method. The study aims to understand how Bright Horizons affects these areas over an 8-week period.