West Haven

Researchers are evaluating a new medicine called ifinatamab deruxtecan I-DXd for treating men with metastatic castration-resistant prostate cancer mCRPC. The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mgkg every 3 weeks or a combination of docetaxel chemotherapy 75 mgm every 3 weeks with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants health will be regularly evaluated with scans and other tests.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer mNSCLC whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1 or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy carboplatin or cisplatin and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1 at 1 or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments impact.

Researchers are evaluating the effectiveness of a long-acting injectable form of buprenorphine compared to the daily sublingual under the tongue buprenorphine in treating Veterans with moderate to severe opioid use disorder OUD. This open-label, randomized controlled trial aims to see which treatment better retains Veterans in opioid therapy and helps sustain opioid abstinence. The study also examines secondary outcomes such as substance use, overdose incidents, infectious disease testing, psychiatric symptoms, housing status, dental health, and cost-effectiveness. Participants are Veterans aged 18 and older diagnosed with moderate to severe OUD and beginning a new treatment episode. After an induction period on daily sublingual buprenorphine, participants are randomly assigned to receive either a 28-day supply of daily sublingual buprenorphine or a monthly injectable buprenorphine shot administered in the clinic. Doses for the injectable form target 300mg, with a 100mg option for those who cannot tolerate the higher dose. Study visits occur weekly during the first month, then every two weeks until week 52, including medication management. Throughout the 52-week active phase, participants report opioid use and provide urine samples every two weeks to evaluate abstinence and treatment retention. Additional assessments include HIV, Hepatitis B and C testing, psychiatric questionnaires, risk behavior evaluations, and dental health surveys. After the active phase, participants are followed passively using medical records for up to 10 years to monitor long-term outcomes. The study expects to recruit 952 Veterans over 7 years across multiple VA Medical Centers.

Researchers are studying how increasing age affects the immediate impact of THC on memory, attention, psychomotor function, feelings of anxiety or reward, and heart rate and blood pressure in adults over 21 years old. The study also explores how age influences the brains electrical activity during information processing and differences in THC metabolism. This trial is conducted by Yale University and is a Phase 1 randomized study. Participants receive either a low or medium dose of delta-9-THC or a placebo, all administered intravenously over 20 minutes. The placebo consists of a small amount of sterile ethanol without THC. Each test day includes two drug administration sessions where these treatments are given, allowing comparison of the effects at different doses and against placebo. During the study, participants will complete memory tests such as the Rey Auditory Verbal Learning Task approximately 25 minutes after each drug administration. They will also provide subjective feedback on various effects through Visual Analog Scales at multiple time points up to 420 minutes after infusion. The trial monitors cognitive, subjective, and cardiovascular responses to THC to understand age-related differences, with participation involving multiple assessments on test days.

Researchers are evaluating the effects of albumin on diuresis in patients with cirrhosis, ascites, and persistent lower extremity edema. This pilot, proof-of-concept, placebo-controlled trial aims to explore how albumin influences sodium excretion, neurohumoral activation, and the risk of acute kidney injury after diuresis in this population. The study is a double-blind, randomized Phase 2 trial sponsored by Anahita Rabiee MD MHS. Participants will receive one dose of either albumin 25 grams infused as 25 albumin or placebo 100 cc of normal saline, followed by at least a 14-day washout period. After the washout, participants will cross over to receive the alternate treatment. This crossover design allows each participant to receive both albumin and placebo during the study. During the study, researchers will measure changes in the fractional excretion of sodium at 6 hours after treatment and monitor neurohormonal markers at 6 and 24 hours. The study involves outpatient participants who will be monitored closely for kidney function, blood pressure, sodium levels, and other safety parameters. Participation will last through both treatment periods plus washout, ensuring thorough assessment of albumins effects compared to placebo.

Chronic pain is a widespread issue affecting Veterans at higher rates than the general public, often leading to difficulties in daily activities, social situations, sleep, and appetite. This research compares two online programs aimed at helping Veterans manage chronic pain an Acceptance and Commitment Therapy for Chronic Pain specifically designed for Veterans VACT-CP and another established program called Online Pain School. The study seeks to evaluate how these digital interventions improve pain management, daily functioning, and quality of life for Veterans living with chronic pain. Participants in the study will be randomly assigned to one of two groups. One group will use the VACT-CP program, which includes seven weekly online modules guided by an interactive virtual coach named Coach Anne, featuring videos, assessments, and personalized goal setting. The other group will complete seven weekly modules of Online Pain School, offering informational videos, behavioral exercises, and wellness techniques for pain management. Both programs last seven weeks, followed by surveys at Week 7, Month 3, and Month 6 to assess their impact. During the study, participants will complete these modules at home and provide feedback through surveys focused on functioning, quality of life, and mental and physical health at multiple time points after treatment. The research team will measure changes in pain intensity using the Brief Pain Inventory and overall health with the Veterans RAND 36 Item Health Survey. Additional assessments include satisfaction with the programs, psychological flexibility, pain acceptance, and values related to chronic pain management. The total involvement spans from the start of the program through six months of follow-up.

Researchers are studying ways to improve access to evidence-based treatments for eating disorders, specifically Bulimia Nervosa and Binge Eating Disorder, among active duty Service members and Veterans. This trial compares two types of cognitive behavioral therapy CBT delivered virtually or as self-help, aiming to reduce binge eating frequency and improve mental health outcomes. The study also seeks to inform VA Clinical Practice Guidelines to better serve diverse and underrepresented populations affected by eating disorders. Participants will be randomly assigned to one of two groups Telehealth Cognitive Behavioral Therapy TeleCBT or Self-Help Cognitive Behavioral Therapy shCBT. TeleCBT involves 8 to 10 individual sessions conducted by a masters-level clinician over three months using an approved video platform. The shCBT group will receive the same treatment materials by mail and complete one chapter per week independently over 12 weeks. Both treatments use the same CBT manual adapted for Veterans. During the study, participants will have assessments at baseline, 3 months post-treatment, and 6 months to measure changes in binge frequency using interviews and questionnaires. Additional evaluations will track depression, PTSD symptoms, overall wellness, and participant engagement and satisfaction. Researchers will monitor progress via surveys and clinical interviews to understand treatment effects and support future implementation. The total participation duration spans at least six months, including follow-up evaluations.

Researchers are evaluating the dose-dependent safety and immediate effects of Cannabidiol CBD on pain and opioid craving in outpatients who have opioid use disorder OUD and are receiving medication-assisted treatment with methadone or buprenorphine. This randomized, placebo-controlled, crossover study involves adults aged 18 to 70 with chronic non-cancer pain lasting at least six months. The study aims to understand how different doses of CBD affect opioid-related outcomes and pain in this population. Participants will attend five visits over about four weeks one screening session and four experimental sessions where they receive oral doses of CBD 400 mg, 800 mg, 1200 mg or a placebo beta carotene solution. Each dose is given before their daily methadone or buprenorphine dose to ensure low opioid blood levels. The study medication order is randomized and spaced by at least 72 hours to prevent carryover effects. During each experimental session, participants will undergo multiple assessments including pain sensitivity tests, opioid craving scales, withdrawal symptom evaluations, mood questionnaires, and cognitive performance tests. Blood samples will be taken at screening and after the final dose to measure drug levels. Safety is closely monitored through a systematic assessment of side effects, and a follow-up phone call occurs one week after the last dose to check on participants well-being.

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer NSCLC stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49 and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, andor PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.