Rhode Island Paid Clinical Trials

HIV medications can be very effective at helping patients have longer, healthier lives. However, many patients do not take their HIV medications as prescribed. This study aims to test a promising HIV medication adherence health coaching intervention delivered primarily via a smartphone application. N = 400 persons living with HIV will be enrolled across two sites (Providence, RI & Atlanta, GA). Participants will be randomly assigned, with a 2:1 ratio, to receive a 1) health coaching session with access to a smartphone application that provides medication reminders and remote access to the health coach or a 2) health coaching session only. Participants will complete interviews at baseline, 1, 3, 6, and 12 months after baseline. Some participants will also complete interviews at 18 and 24 months after baseline. Data analysis will examine the extent to which the intervention improves ART medication adherence, as well as other factors, compared to the control condition, which approximates standard of care. Read Less

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly. Read Less

The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are: Which of the three Internet-delivered weight loss programs results in the greatest weight loss? How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? What individual characteristics predict success in each arm? What are the underlying mechanisms of each approach? Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). Participants will: signed informed consent complete a baseline assessment be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE complete a training workshop to learn arm-specific cognitive strategies complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons complete an assessment at 3 months (during treatment) complete a refresher workshop on arm-specific cognitive strategies at 3 months complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment Read Less

This study will help determine the tolerability and efficacy of the mood-stabilizing anticonvulsant lamotrigine in youth with alcohol use disorder. It will also help establish whether and how lamotrigine improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted. Read Less

The goals of this study are as follows: To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS). To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event. Read Less

Objective: Preliminary studies show that low intensity focused ultrasound (LIFU), a new type of non invasive brain stimulation (NIBS), may be able to reach deep structures of the brain involved with depression and anxiety, that remain inaccessible using current forms of NIBS with precision. In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms. The primary objectives of this study are to test the safety and tolerability of LIFU, evaluate the feasibility of using LIFU to reduce brain activity, and evaluate the feasibility of simultaneous fMRI-LIFU. If the results of this study are positive, what the investigators learn will serve as a strong foundation for the future development of innovative treatments for a variety of psychiatric disorders. Research Procedures: 25 patient and 25 healthy veterans will be recruited. Visits will take place at the VA Providence Healthcare System. During some visits, healthy and patient participants may undergo clinical and research neuroimaging, neuropsychological testing, complete questionnaires, and participate in clinical/neurological assessments. Healthy veterans will not receive LIFU and will only attend 2 study visits. Patients are expected to attend up to 8 visits over 6 weeks. However, some may require up to 6 extended follow-ups after visits 5 or 8, in which case they would attend a total of 11 or 14 visits over 6 months. Two patient visits will include the LIFU application, following FDA safety guidelines. Patients will be assigned either to an experiment in which LIFU stimulation will be delivered immediately prior to a task or to an experiment in which stimulation will be delivered during the task. Within each experiment, patients will be assigned to first receive either LIFU stimulation to the study target or anatomical control. Study staff, but not participants will know which location is being targeted in case safety concerns arise. Safety assessments will be conducted at follow-up visits. A clinician will be available during LIFU administration /follow-up visits. Assuming no injury or other concerns are present, patients will then repeat this process again, receiving stimulation targeting other brain area not previously selected. Read Less

This study will examine whether moderate alcohol use in the context of HIV infection exacerbates inflammatory signaling in the immune system and brain. The study will recruit healthy individuals and people living with HIV infection who are otherwise in good health to participate. Participants will complete an experimental protocol that involves controlled alcohol administration and magnetic resonance imaging (MRI). Primary outcomes are plasma biomarkers of inflammation and MRI markers correlated with neuroinflammation. Results will advance understanding of the effects of alcohol use in people living with HIV infection. Read Less

The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. The investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group. Read Less

The objective of this clinical trial is to examine whether non-invasive brain stimulation can modulate dysfunctional brain dynamics underlying adolescent ADHD to subsequently improve clinical symptoms. Read Less

The open trial will examine the feasibility and acceptability of a brief, empirically-supported acceptance-based behavioral therapy intervention to promote retention in care for out-of-care people with HIV who use substances. Read Less

The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care. The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition. Read Less

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity. Read Less