Clinical trials

Project Summary The goal of this pilot clinical trial is to assess contingency management (CM) for increasing attendance at outpatient clinics after Medication for Opioid Use Disorder (MOUD) prescription and clinic referral occurred in the hospital Emergency Department (ED). * The researchers will compare usual care (UC)+CM to UC alone to see if 1) CM works to promote MOUD clinic attendance after discharge from the ED and 2) demonstrate feasibility of providing CM in the ED and outpatient MOUD clinic settings. * Researchers will randomize 30 adults who started MOUD in the ED into two conditions. These conditions consist of (A) UC alone: A referral to an outpatient buprenorphine or methadone provider with reminders from STAR program staff or (B) UC+CM: UC plus financial incentives dependent on MOUD clinic attendance to receive an MOUD prescription. The primary outcome of interest is the number of participants who receive their first MOUD prescription from the outpatient clinic after discharge from the ED in UC+CM compared to the UC-only condition. A secondary outcome will be the proportion of participants who kept attending outpatient MOUD treatment by the end of the 30-day study period between UC+CM and UC conditions. An exploratory outcome will be biochemically-verified illicit opioid abstinence measured at day 30.

Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.

The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is: Does PE+ decrease PTSD symptoms? All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning. Participants will: * Receive individual PE+ therapy for 1 hour weekly for 12 weeks. * Receive financial incentives for attending each PE+ session. * Attend assessment visits every 4 weeks for the 12 weeks of the trial. * Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.

The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.

This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of a new lung nodule, either confirmed or suspicious for lung cancer, with a plan for lung cancer treatment with or without surgical resection will be recruited from the University of Vermont Medical Center (UVMMC)pulmonary, cardiothoracic surgery, and Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications. Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the tumor, but rates of incomplete tumor regression and positive surgical margins remain high. This Phase Ib/II, single-arm study evaluates the safety and feasibility of adding trans-arterial microperfusion (TAMP) delivery of gemcitabine to standard neoadjuvant therapy for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT). After completion of chemoradiation, gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy drug for pancreatic cancer, and the study is evaluating a novel method of delivering the drug rather than a new medication. The primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine in this treatment setting. Secondary objectives include evaluation of surgical margin status and pathologic tumor regression following surgical resection. Exploratory analyses will examine relapse-free survival. Results from this study will help determine whether this locoregional chemotherapy approach can be safely integrated into neoadjuvant treatment strategies for patients with borderline resectable PDAC.

This is a prospective randomized trial designed to investigate a new care model for patients who suffer from nerve damage from chemotherapy called chemotherapy induced peripheral neuropathy (CIPN). All participants in the study will report their CIPN symptoms daily using a website, app or phone for 12 weeks. In one group the data will be collected and participants will be encouraged to reach out to their treating doctors for uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel is appropriate. In the second group, if the symptoms meet the criteria for eligibility they will receive a phone call from a nurse practitioner either the same day or next day, depending on the time symptoms were logged. That nurse practitioner will determine the correct CIPN treatment using an algorithm and prescribe it. The study will track the severity of symptoms over time as well as looking at the impact on treatments for CIPN (medications and referrals).

People who responded to the World Trade Center (WTC) disaster on September 11, 2001 were exposed to toxic dust and smoke and have higher rates of certain health problems, including prostate cancer. Many WTC Responders with prostate cancer experience ongoing physical limitations, fatigue, and reduced quality of life, even after completing cancer treatment. Regular exercise can improve strength, balance, physical function, and well-being in people with cancer, but many men with prostate cancer do not meet recommended physical activity levels. Barriers such as travel, health concerns, and lack of access to tailored programs can make it difficult to participate in exercise programs. This pilot study will test whether a remotely delivered, supervised group exercise program is feasible and acceptable for WTC Responders with prostate cancer. The exercise program is delivered live by videoconference and is based on an established, evidence-based program for older adults. It includes aerobic, strength, balance, and flexibility exercises and is designed to be safe, supportive, and accessible to people living in different locations. A total of 40 WTC Responders with a history of prostate cancer will take part in this study. Participants will be randomly assigned to either (1) a 16-week remote exercise program or (2) a waitlist control group that receives usual care during the study period and is offered the exercise program after completing all study assessments. Participants in the exercise group will attend three one-hour exercise sessions per week using videoconferencing. The main goals of this study are to determine whether participants can be successfully recruited and retained, whether they attend and complete the exercise sessions, and whether they find the program acceptable and helpful. The study will also explore whether the exercise program improves physical function, physical activity, and quality of life. Physical function will be measured using simple movement tests performed remotely, and physical activity will be measured using a wearable activity monitor. Participants will also complete questionnaires about their health, physical functioning, and experiences with the program. In addition, this study will evaluate whether it is feasible for participants to collect saliva samples at home and return them by mail for future research. A subset of participants will be invited to complete interviews to share their experiences and provide feedback on how the program could be improved. Results from this pilot study will help inform the design of a larger future trial aimed at improving physical function and quality of life for WTC Responders with prostate cancer through accessible, remotely delivered exercise programs.

Lateral elbow pain can significantly limit people's ability to do the activities they want or need to do. We want to explore if one treatment technique is better than another for people with lateral elbow pain. You will be placed in a traditional treatment group or in a non-traditional treatment group. Your placement in the group will depend on past treatments you have had for this pain. Before you start treatment, you will be given four tests: 1) a grip strength test, 2) a pinch test, 3) a pain level survey, and 4) a functional survey. These four tests will take no longer than 15 minutes to complete. These four tests are common tests given to people with elbow pain. You will be given these four tests: * At the beginning, before you start treatment * At 2-weeks * At 4-weeks * At the end of your treatment Traditional treatment group: You will receive treatment 1x/week for 4-6 weeks. The traditional treatment group will consist of the following treatments: * stretching and strengthening of the wrist extensors * soft tissue work to the forearm muscles * joint mobilization at the elbow * rigid and elastic taping with focus on the wrist extensor muscles * ergonomic strategies * transcutaneous electrical nerve stimulation (TENS) * wrist splinting Non-traditional (TINLL) treatment group: You will receive treatment 1x/every 1-2-weeks for 4-6 weeks. The non-traditional (TINLL) treatment group will consist of the following treatments: * joint and tendon mobilization at the elbow * elastic tape for muscles and nerves * stretching/strengthening of the muscles at the elbow and upper arm * ergonomic strategies

This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.

Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience. This study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a "Khorana score" of 2, which puts them at intermediate risk for developing blood clots. The study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups: Group 1: Apixaban 2.5 mg twice a day (standard prophylactic dose) Group 2: Apixaban 5 mg once a day (an alternative, more convenient dose) Group 3: No anticoagulant (standard care) Participants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period. By comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk. This is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.

Why Is This Research Study Being Conducted? * The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke. * Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients. * By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS

This study is focused on home modifications and the changes that older adults may experience while aging. We are conducting this study to better understand how people feel about making changes to their homes or utilizing equipment to assist with home tasks.

The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is: * Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants? Participants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD). NE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest. NE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member). All participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.

In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)/oleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA/OA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.

The goal of this clinical trial is to test a method of preventing substance use among adolescents. Young people aged 11-14 who have depression, anxiety, or attention deficit hyperactivity disorder (ADHD) are at higher than usual risk for starting substances such as alcohol, tobacco products, or drugs. The main question the investigators aim to answer is: "Will watching short videos in their doctor's office every three months that were made by other adolescents in their community about not using drugs and other substances prevent at risk adolescents from starting to use those substances?" The investigators will measure the outcome by asking participants to complete a survey every three months. The survey is a standard set of questions about behavior, including substance use. If they have started to use substances, they will get treatment for substance use. If they have not, they will watch another video and come back three months later to repeat the survey.

Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, many established dual users maintain long-term smoking and the majority who use e-cigarettes non-daily are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that adults who exclusively smoke cigarettes respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded people who regularly use e-cigarettes and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US, but policy makers have proposed restricting e-cigarettes to ≤ 2% nicotine to curb youth e-cigarette use, and several states have already set limits to reduce nicotine in e-cigarettes. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potential for e-cigarettes to substitute for cigarettes and diminish the benefits of a nicotine-limiting standard for cigarettes among dual users. This study is a 12-week double-blind 2 cigarette level (Normal Nicotine vs Very Low Nicotine) x 2 e-cigarette level (High Nicotine vs Low Nicotine) between-subjects factorial trial to investigate how a nicotine-limiting standard for cigarettes affects adult dual users and whether these effects are impacted by constraints on e-cigarette nicotine concentration. Outcome measures include cigarettes per day, cigarette dependence, and toxicant exposure. The research is highly relevant to FDA CTP domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces smoking and dependence, and whether these effects are moderated by the availability of high vs low nicotine e-cigarettes.

Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.

The PRESERVE \& CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.

The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.