West Haven

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating two forms of buprenorphine treatment for Veterans with moderate to severe opioid use disorder (OUD). This Phase 4, open-label, randomized controlled trial aims to compare a 28-day injectable subcutaneous buprenorphine formulation at a target dose of 300 mg with the standard daily sublingual buprenorphine dose ranging from 4 to 32 mg. The study will recruit 952 Veterans over seven years and follow them actively for 52 weeks, with additional passive follow-up via medical records for up to 10 years. The study also explores secondary outcomes including other substance use, overdose incidents, infections like HIV and hepatitis, incarceration, quality of life, mental health symptoms, housing, dental health, and cost-effectiveness. Participants will begin induction on daily sublingual buprenorphine using standard guidelines to reach a target dose between 4 and 32 mg within 45 days. After reaching this dose, participants are randomly assigned to either continue daily sublingual buprenorphine with naloxone, prescribed in 28-day take-home supplies, or receive monthly injectable buprenorphine administered in the clinic. Both treatment groups have visits at weeks 1, 2, 3, and 4 post-randomization, then every two weeks until week 52, with medication management provided at each visit. During the study, participants will provide self-reports of opioid abstinence and undergo urine drug screenings every two weeks. Medication adherence and retention in treatment are tracked approximately every four weeks. After the active 52-week period, participants will be followed passively through electronic medical records for up to 10 years to monitor long-term outcomes. This comprehensive approach aims to assess the effectiveness and safety of these treatments for opioid use disorder in Veterans.

Researchers are investigating how increasing age affects the immediate impacts of THC on cognition, subjective feelings, and cardiovascular functions in adults over 21 years old. The study focuses on understanding if older adults are more vulnerable to changes in memory, attention, psychomotor skills, feelings of anxiety or reward, heart rate, and blood pressure after THC use. Additional goals include examining age-related differences in brain activity related to information processing and how THC is metabolized with age. Participants receive one of three intravenous treatments administered over 20 minutes: a low dose of active Delta-9-THC, a medium dose of active Delta-9-THC, or a placebo containing a small amount of sterile ethanol without THC. Each test day involves two drug administration sessions, with cognitive tests scheduled approximately 25 minutes after each dose to assess immediate effects. During the study, participants undergo the Rey Auditory Verbal Learning Task to measure memory performance shortly after drug administration. Researchers will monitor cognitive, subjective, and cardiovascular responses, along with electrophysiological brain activity to evaluate information processing. The study includes assessments of THC metabolism and requires participants to meet education and language criteria while ensuring safety through screening for serious medical or psychiatric conditions. The trial is conducted in a Phase 1 setting, focusing on acute effects of THC with careful monitoring throughout.

This trial investigates the effects of albumin infusion on diuresis in adult patients with cirrhosis who have ascites and persistent lower leg swelling despite oral diuretic treatment. It is a small, pilot proof-of-concept, placebo-controlled, double-blind randomized trial designed to explore albumin's impact on preventing neurohumoral activation and acute kidney injury following diuresis in this population. Participants receive either 25 grams of albumin infusion or 100 cc of normal saline as a placebo. The study compares the effects of these treatments on kidney function by measuring the change in fractional excretion of sodium six hours after administration. The trial focuses on patients with decompensated cirrhosis complicated by ascites and peripheral edema. During the study, participants will be monitored closely to evaluate kidney sodium excretion and kidney safety. Researchers will assess changes from baseline to six hours post-treatment. The study includes safety monitoring and excludes patients with recent changes in diuretic therapy or albumin infusion, significant kidney impairment, recent infections, bleeding, or severe heart and lung conditions. The total participation time includes screening and treatment with follow-up assessments.

Chronic pain is a common and serious issue among Veterans, affecting their daily functioning, social interactions, sleep, and appetite. Veterans experience higher rates of chronic pain and severe pain compared to the general public, leading to increased health problems and reduced quality of life. Traditional medication treatments have limited success and potential risks, creating a need for innovative, accessible, non-medical pain self-management options. This research compares an online Acceptance and Commitment Therapy for Chronic Pain designed specifically for Veterans (VACT-CP) with an active online control program called Online Pain School to see how each supports pain management and improves functioning and quality of life. Participants will take part in one of two digital pain management programs. The VACT-CP group completes seven weekly online modules guided by an interactive virtual coach named Coach Anne, featuring personalized text-based conversations, videos, and goal-setting activities. The Online Pain School group also completes seven modules each lasting 15 to 20 minutes, providing educational videos, behavioral exercises, and wellness strategies to support pain self-management. Both programs are designed for at-home use to overcome barriers such as transportation and time constraints. During the study, researchers will assess changes in pain intensity, functioning, and quality of life at Week 7, and again at 3- and 6-month follow-ups using standardized measures including the Brief Pain Inventory and the Veteran's RAND 36 Item Health Survey. Participants' interactions with the programs and their feedback will be monitored to evaluate usability and impact. The total study duration includes these follow-up assessments to understand both short- and longer-term effects of the interventions.

Researchers are evaluating new virtual treatments designed to improve care for active duty Service members and Veterans who have binge-eating disorder or bulimia nervosa. This study aims to compare two types of Cognitive Behavioral Therapy (CBT) delivered through telehealth: therapist-led TeleCBT and Self-Help CBT (shCBT). The study focuses on improving access to evidence-based care and aims to inform VA Clinical Practice Guidelines for eating disorders, especially for Veterans and underrepresented populations. The treatment involves three stages of CBT adapted specifically for Veterans and written at a seventh-grade reading level. Stage 1 introduces the CBT model, discusses treatment goals, and teaches self-monitoring of eating behaviors; Stage 2 focuses on maintaining healthy eating and increasing cognitive skills; and Stage 3 emphasizes practicing skills and preventing relapse. Treatments are delivered virtually, allowing participants to access care anytime and anywhere through VA's telehealth technology. Participants will be assessed at the start, after 3 months of treatment, and again at 6 months. Researchers will measure changes in binge eating frequency using interviews and self-report questionnaires, as well as other mental health and quality of life outcomes. The study also includes expert panel reviews to develop recommendations for broader implementation. Safety and eligibility screenings consider mental health status and medical conditions, and the total study duration includes treatment and follow-up assessments.

Researchers are evaluating the dose-dependent safety and acute effects of Cannabidiol (CBD) on pain and opioid craving in adults aged 18 to 70 with opioid use disorder (OUD) and chronic non-cancer pain lasting at least six months. Participants are currently receiving medication-assisted treatment with methadone or buprenorphine. This randomized, placebo-controlled, crossover early phase 1 study aims to understand how different doses of CBD affect these outcomes in outpatients with OUD. Participants will attend five visits over about four weeks, including one screening session and four experimental sessions. In the experimental sessions, before their daily opioid treatment, participants will receive oral doses of CBD at 400 mg, 800 mg, or 1200 mg, or a placebo. These sessions are spaced at least 72 hours apart to reduce carryover effects. Blood samples will be collected at the beginning and end of the treatment phase to measure drug levels. A physician will evaluate participants before discharge at each session, and a follow-up phone session will occur one week after the last dose. During the study, researchers will assess pain using sensory tests and scales, opioid craving through visual tasks and questionnaires, and withdrawal symptoms with a specific scale. Abuse potential and safety will be monitored using standardized questionnaires. Cognitive functions will be tested with verbal learning and performance tests. These assessments occur at baseline and various times after CBD administration to understand its effects. The total participation time is approximately four weeks, with safety and tolerability closely observed throughout.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.