Cumberland

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Stimulant use among people with opioid use disorder leads to serious complications including persistent opioid use, higher risk of HIV infection, and increased family, medical, legal, and vocational problems. Medication for opioid use disorder helps treat opioid addiction but does not reduce stimulant use, which worsens treatment outcomes. This research evaluates a multi-level implementation strategy called the Science of Service Laboratory, designed to increase the use of contingency management, an evidence-based behavioral intervention that supports stimulant abstinence, in opioid treatment programs. The study uses a type III hybrid effectiveness-implementation trial with a stepped wedge design across public addiction treatment programs in Rhode Island and Illinois. The Science of Service Laboratory includes three main components: didactic training through workshops and monthly coaching calls, performance feedback via practice sessions and electronic medical record reports, and ongoing facilitation through monthly calls. Programs are enrolled in four cohorts and will receive this multi-level strategy to help implement contingency management for stimulant use. Data will be collected from de-identified electronic medical records on contingency management delivery and patient outcomes. Staff will also provide feedback about factors affecting the implementation process. Participants include opioid treatment program counselors who support patients receiving medication for opioid use disorder and patients newly started on medication who also use stimulants. The study monitors changes in the percentage of patients receiving contingency management and counselors delivering it over 10 months. Researchers will assess implementation outcomes such as reach and adoption, as well as patient outcomes like stimulant abstinence and treatment retention. The project also examines contextual factors influencing success and aims to improve addiction treatment services.

Researchers are evaluating two different medication classes for patients with type 2 diabetes who have established atherosclerotic cardiovascular disease (ASCVD) or are at high risk for ASCVD. This Phase 4 clinical trial aims to compare the total number of cardiovascular events, kidney events, and deaths between treatments using sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA). The study plans to enroll 6,000 participants and follow them to assess the occurrence of heart attacks, strokes, arterial procedures, heart failure hospitalizations, kidney failure treatments, and mortality. Participants will be randomly assigned to receive either SGLT2 inhibitors (empagliflozin, dapagliflozin, or canagliflozin) or GLP-1 receptor agonists (dulaglutide, liraglutide, or semaglutide). The trial compares these two medication types in a 1:1 ratio. Patients will continue their usual diabetes care with adjustments for safety, and those already taking one of the study medication classes may stop their current drug to be randomly assigned. The trial uses an open-label, pragmatic design reflecting real-world treatment. During the study, researchers will monitor participants for the total number of cardiovascular and kidney-related events as well as deaths over an average follow-up period of about three years. Data collection will include medical records accessed via electronic health records and medical releases. Outcomes include heart attacks, strokes, arterial revascularization, heart failure hospitalizations, kidney failure events, kidney transplants, and mortality. Safety and adherence will be regularly assessed throughout the study period.

Researchers are evaluating a hospital-led program in Rhode Island designed to improve health outcomes for pregnant people by addressing social factors that affect pregnancy and baby health. This project brings together hospitals, community health workers, doulas, and local organizations to create a service model that targets care coordination and social needs such as food, housing, and transportation. The study aims to reduce severe maternal complications and deaths, as well as racial health disparities, through this community-based maternal support services (COMSS) program. The COMSS program will be implemented in six prenatal clinics over four years. It includes universal screening at multiple points during pregnancy and postpartum to identify risks related to social determinants, substance use, mental health, and pregnancy complications. Patients who screen positive receive support from care managers and community health workers, who provide navigation, referrals, and connections to local resources addressing food, housing, and transportation needs. Care teams follow patients until at least three months after birth before transitioning them to primary care. Participants will be monitored through screenings at the first prenatal visit, second and third trimesters, delivery, and 2-6 weeks postpartum. Care managers and community health workers maintain secure registries and provide follow-up weekly or biweekly as needed. The main outcome measured is the rate of severe maternal complications and death from enrollment through one year after birth. Data will be collected from all clinics before and after the program implementation to evaluate its impact over time.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.

Researchers are investigating a family-centered approach to prevent substance use disorder (SUD) among youth aged 12 to 18 who have parents in recovery. This pilot randomized controlled trial aims to optimize a dyadic intervention called Modified Family Talk, designed to strengthen family resilience, coping skills, and future planning to reduce youth substance use risk. The study seeks to gather preliminary data on feasibility, study parameters, and intervention targets to inform a larger efficacy trial. The study compares two groups: one receiving the Modified Family Talk intervention consisting of six one-hour sessions delivered over 12 weeks every 1 to 2 weeks, and a control group receiving comprehensive, patient-centered care including addiction treatment services, adolescent substance use specialists, social work, behavioral health, and patient navigators. The intervention will be refined through feedback from participants and providers after each session in an iterative process. Participants will be assessed throughout the 12-month study period for participation rates, reasons for not enrolling, attrition, number and duration of sessions attended, and other study logistics. Researchers will collect structured feedback and study measures to evaluate acceptability and feasibility. The ultimate goal is to develop an effective, family-focused prevention strategy for youth substance use that can be integrated into primary care settings.