21 Clinical Trials for Various Conditions
There is a need to understand how long anesthetic drugs last in the brain during surgery on the ascending aorta or aortic arch. Drugs can have a prolonged effect when blood temperature is made cold therefore the influence of temperature needs to be studied. This type of surgery allows us to answer questions about how anesthetic drugs behave when they are given during a routine portion of surgery. Patients will be provided with anesthetic drugs during surgery while on a heart lung machine. After the drug is injected into the heart lung machine it will be delivered to the brain to provide more sleep and pain relief. Immediately after the injection of anesthetic drugs, blood samples will be taken from an existing intravenous line in the neck and plasma drug concentrations measured. This will help us to understand how long drugs last in the brain during this type of surgery.
The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants: * will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino * or receive both EBT and SOC at ARC * in the SOC group will continue monthly visits at ARC and weekly counseling * in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone * will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC
This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.
The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness. Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.
The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during IV sedation in adults with chronic pain and depression. We do not know whether ketamine will be more effective than placebo under these circumstances. This study aims to: * Evaluate whether placebo is non-inferior to ketamine in treating chronic pain and depression, when delivered under propofol sedation * Confirm that propofol sedation is a safe way to keep participants blinded to treatment * Assess patients' comfort with the sedation process to improve future studies * Explore whether patient expectations affects their pain and depression Participants will: * Need to qualify for the study based on stringent medical criteria * Undergo sedation with propofol * Randomly receive either a ketamine or a placebo (saline) infusion during sedation * Complete several study assessments over 5-7 weeks
This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.
Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function. Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform. Aim 2: To assess Veteran acceptability and usability of the COAST platform. Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognitive Behavioral Therapy for Insomnia (CBTI) for enhancing hypnotic discontinuation rates. A blinded SMT+CBTI intervention will be compared to open-label SMT+CBTI.
Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk than individuals with only one of these disorders. Ketamine given as repeated infusions has been shown to be effective in rapidly reducing PTSD and MDD symptoms in treatment resistant PTSD+MDD individuals. However, knowledge about the mechanisms underlying comorbid PTSD and MDD remain limited. The purpose of this study is to use repeated ketamine infusions as a probe to validate a model of PTSD+MDD that focuses on neuroanatomy and executive functioning.
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI). This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity. Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment. If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.
Treatment seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine or newer benzodiazepine receptor agonist, For some patients, short term or intermittent use provides satisfactory insomnia relief. However, more than 65 percent of individuals who are prescribed hypnotics use them for more than a year, and over 30 percent remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non drug insomnia therapy such as as cognitive behavioral insomnia therapy or Cognitive Behavioral Therapy For Insomnia (CBTI) achieve sustained insomnia remission lon after a time limited course of treatment. However it is difficult for most long term hypnotic users to convert to a self management approach. Intervention that combine CBTI with a supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50 percent of patients who receive this treatment either fail to discontinue hypnotics or resume them over time. Previous research provides only rudimentary understanding of how to help long term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBTI techniques. This R34 gathered key pilot data to address these limitations. Specifically this project compared the currently recommended tapering pace which is a 25 percent dose reduction every two weeks with a slower 10 percent dose reduction every two weeks. The study also conducted all tapering in double blinded fashion. A total of 78 patients were enrolled and first completed a course of CBTI over a six week period. They they were randomized to of of the two tapering conditions or to a control (CTRL) condition in which their medication was not tapered. After the 20 week tapering period the study blind was eliminated and those in the CTRL condition were offered an open label tapering period. All patients were assessed for hypnotic use at the end of their respective tapering periods and then again 3 months later. Study key outcome measures included hypnotic discontinuation rates, nights per week hypnotics were used and weekly diazepam dose equivalents of hypnotics used. This line of research should inform clinical practice by helping to refine guidelines for tapering controlled substance hypnotic medications.
The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning. Veterans with both depression and PTSD have been shown to be at much higher risk of suicide than individuals with only one of these disorders. Ketamine has been shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms. The purpose of this study is to see whether ketamine, when given as repeated infusions, can produce quick and sustained improvement in depression and PTSD symptoms for individuals who have not had their symptoms effectively treated by current treatments.
The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.
The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (\> 24 hours) in critically ill patients who require mechanical ventilation.
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.
Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids, and midazolam
The purpose of this project is to examine the impact of sleeping pills and waking up in the middle of the night on walking balance and cognitive function, to identify risk factors for falls in older adults. A significant percentage of falls, approximately 33 to 52 percent, occur during the nighttime and morning hours when people are normally sleeping; therefore, it is possible that sleep and sleeping medication related impairments in balance may contribute to this risk.