69 Clinical Trials for Various Conditions
The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.
Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Researchers in Canada developed a printed self-help packet that enabled many individuals to reduce or cease taking benzodiazepines on their own. This study is designed to tailor that packet to the Veteran population, convert it to an app that people can use on their laptop or smart phone, and test whether the app helps promote benzodiazepine prescribing.
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use. The goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use BZDs.
The purpose of this effort is to use informative e-mails to improve the process of prescribing of opioids and benzodiazepines within the National Capital Region/Military Health System (NCR/MHS), with the aim of decreasing concurrent opioid and benzodiazepine prescribing.
Delirium within the intensive care unit (ICU) is associated with poor outcomes such as increased mortality, ICU and hospital length of stay (LOS), and time on mechanical ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing duration of delirium and subsequent complications. This is a single-center randomized, double-blind, placebo-controlled study of critically ill adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that flumazenil continuous infusion may reverse hypoactive delirium associated with BZD exposure and thereby reduce duration of delirium and ICU LOS.
Benzodiazepine dependence is a growing public health problem for which very few evidenced-based treatment approaches are available. Approximately 683,000 individuals met past year criteria for sedative-hypnotic use disorders in the US during 2010, a prevalence greater than heroin or methamphetamine dependence. The most commonly prescribed sedative-hypnotic agents are the benzodiazepines. Chronic use induces pharmacodynamic tolerance in the GABA neurotransmitter system and individuals with physiological dependence find benzodiazepines difficult to discontinue because of withdrawal or rebound symptoms, which include autonomic arousal, depression, anxiety, and insomnia. Available evidence-based treatment approaches have been primarily directed at therapeutic users of benzodiazepines who do not meet criteria for a substance use disorder, with a general consensus that the gradual taper of benzodiazepines over a period of several months is the optimal approach. However, patients with benzodiazepine dependence are typically referred for inpatient detoxification treatment, which rapidly tapers patients off benzodiazepines. Protracted withdrawal symptoms frequently persist after discharge, predisposing patients to relapse. More effective pharmacotherapeutic strategies are needed for the treatment of benzodiazepine dependence in the outpatient setting.
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and indices of psychosocial function will all improve, while BZ use will decrease significantly during a twelve-week trial period of substituting quetiapine for benzodiazepines.
The aim of this project is to study the use of gabapentin in reducing benzodiazepine abuse in methadone maintenance patients. A second aim is to study the effects of gabapentin on craving, mood, anxiety, and sleep disturbance in methadone maintenance patients abusing benzodiazepines. The proposed protocol is a randomized, double-blind, placebo-controlled pilot outpatient trial of gabapentin in the treatment of benzodiazepine abuse in methadone maintenance patients. All subjects will receive weekly manual-guided psychotherapy directed at achieving abstinence and improving current functioning. The primary outcome measure, benzodiazepine use, will be assessed weekly by a combination of self-report (time line follow-back method) and urine toxicology. Associated psychological symptoms of craving, mood, anxiety, and sleep disturbance, will be assessed by a combination of clinician and self-rated instruments. The investigators hypothesize that individuals receiving methadone maintenance treatment who are abusing (nonprescribed use) benzodiazepines have difficulty in reducing or discontinuing benzodiazepine use because of the significant anxiety, mood, and sleep disturbance symptoms that accompany reduction in use. Gabapentin, an anticonvulsant which has anxiolytic and sedating properties, may alleviate the symptoms associated with a reduction in benzodiazepine abuse and make the achievement of abstinence more likely when administered in the setting of an active psychotherapy condition.
The goal of this clinical trial is to conduct a single-arm pilot trial of a brief cognitive-behavioral therapy-enhanced benzodiazepine deprescribing intervention in 20 older adults (aged ≥55 years) prescribed chronic benzodiazepines by their primary care clinicians.
Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.
Over 21 million surgical procedures take place among adults aged 65 and older in the US each year, and most older surgical patients in the US now receive benzodiazepines (e.g., midazolam, lorazepam) during anesthesia care. This occurs despite recommendations to avoid these medications in older patients due to associated medical risks and lack of demonstrated benefit. In other words, routine benzodiazepine administration to older surgical patients is likely to represent low-value care that is a suitable target for de-adoption. In this study, we will evaluate a United States Anesthesia Partners (USAP, Dallas, TX) quality improvement initiative using peer comparison feedback to clinicians and/or mailed informational letters to patients as strategies to encourage physician de-adoption of routine preoperative benzodiazepine administration to older surgical patients. In partnership with USAP, this study will be conducted using randomization to evaluate its effect.
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy (OAT) who currently use benzodiazepines versus a Relaxation Therapy (RT) control condition. The DT-BD intervention is an adjunctive psychosocial intervention in people seeking to discontinue (BZD) use.
In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.
The purpose of this study is to examine the safety, acceptability, and feasibility of a controlled taper off of opioids and/or benzodiazepines, with the use of behavioral health tele-health based therapy services, in the perioperative patient.
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology. The analgesia-sedation protocol will be implemented for patients admitted to the pediatric ICU who require mechanical ventilation for greater than 24 hours. Specifically, we will examine the impact of this implementation on total benzodiazepine usage, ICU length of stay, and ventilator free days, using a pre- and post- algorithm implementation comparative design.
To examine the differences in the capacity to activate microglia in patients with Alzheimer's Disease (AD) compared to age-comparable cognitively normal subjects and younger healthy controls.
B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.
The overall goal of this protocol is to evaluate microglial activation in the brain using \[18F\]PBR06 in patients with amyotrophic lateral sclerosis (ALS).
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.
Benzodiazepine (BZD)/opioid polysubstance abuse (PSA) dramatically increases risks of overdose, disability and death; however, little is known about phenotypes that could be targeted to decrease this use and these associated risks. The opioid abuse epidemic is generating unprecedented numbers of overdoses (OD) and deaths from prescribed and illegal sources (e.g. fentanyl combined with, or sold as, heroin). Yet, medical and epidemiological data suggest these adverse outcomes are not solely due to over-consumption of opioids.The FDA recognizes the health danger of BZD/opioid PSA, and issued labeling changes for prescribing BZDs and opioids. Impact of these changes is unclear and could be minimal if people obtain these substances illegally. BZD abuse can be harmful alone or combined with opioids, as BZDs: (a) contribute to OD/death e.g. 31% of opioid OD-related deaths from 1999 to 2011 were related to coincident BZD use, BZD co-use is dose-dependently related to mortality and rates of BZD OD deaths have sharply increased. (b) exacerbate progression and adverse outcomes of opioid abuse. and (c) worsen behavioral impairment from opioids, increase rates of falls and fractures, motor vehicle accidents, and sleep-disordered breathing. There has been limited systematic research of BZD/opioid PSA. This is a major gap because BZD are often co-prescribed with opioids (in 33 to 50% of cases) and are easily obtained illegally. In response to these problems, there is an urgent need to obtain population-level, clinical pharmacology, and mechanistic data to test our unified hypothesis of dual-deficit in affective/hedonic regulation.
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies. This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.
The goal of this project is to reduce chronic benzodiazepine use through two approaches: direct patient education or direct patient education paired with additional support and encouragement from a behavioral health care manager.
The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.
This study will use positron emission tomography (PET) to measure a receptor in the brain that is involved in inflammation. It will test two radioactive chemicals used in the procedure to see if the newer chemical, \[(11)C\]B, is as good or better than the older one, \[(11)C\]A, for measuring brain inflammation. Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo an evaluation, \[(11)C\]A PET scan, \[(11)C\]B PET scan and magnetic resonance imaging (MRI), as follows: Evaluation Medical history and physical examination, blood and urine tests PET scans * \[(11)C\]A scan. A catheter (plastic tube) is placed in an arm vein for injection of the \[(11)C\]A isotope. Some patients also have a catheter placed in an artery in the wrist to collect arterial blood samples during the scan. Subjects then lie on the scanner bed and a special mask is fitted to the head to help keep the subject s head still during the procedure. Following an 8-minute scan to calibrate the scanner, the \[(11)C\]A is injected into the catheter in the vein and pictures are taken that show where chemicals related to inflammation are present. The procedure takes about 2.5 hours. * \[(11)C\]B scan. The procedure is the same as above for \[(11)C\]A, except the isotope used is \[(11)C\]B. MRI scan. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scan. ...
This study will use positron emission tomography (PET) imaging to measure a receptor in the brain that is involved in inflammation. Certain neurological disorders, possibly including frontotemporal dementia (FTD), are associated with increased inflammation in the brain. This study may help elucidate the relationship between FTD and inflammation. Patients with FTD and healthy volunteers who are 35 years of age or older may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood and urine tests. Participants undergo the following procedures: * Whole body PET scan: PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain so the activity can be seen with a special camera. The tracer used in this study is \[11C\]PBR28. Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to inject the tracer. Pictures are taken for 1 hour. This short scan is done to determine if \[11C\]PBR28 binds to the subject s receptors, since a number of people do not have binding. Subjects who have binding continue with brain PET and MRI scans, described below. * Brain PET imaging: Before starting the scan, a catheter is placed in a vein in the arm to inject the tracer,\<TAB\> and another catheter is placed in an artery in the wrist to obtain blood samples during the scan. The subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed to help keep the person s head still during the scan so the images will be clear. An 8-minute transmission scan is done just before the tracer is injected to provide measures of the brain that are helpful in calculating information from subsequent scans. After the tracer is injected, pictures are taken for about 2.5 hours, while the subject lies still on the scanner bed. * Blood and urine tests are done the day of and the day following each PET scan. * Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of the PET scan. This procedure uses a magnetic field and radio waves to produce images of the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The test takes about 1 hour....
Inflammation in the vascular wall is important in atherosclerosis and the blockage of the artery. The peripheral benzodiazepine receptor is involved in inflammation and in this protocol we will attempt to take pictures, using PET camera, of inflammation in patients with atherosclerosis and compare those of healthy people.
The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain using positron emission tomography (PET) and compare the imaging results between patients and healthy people.
The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain using positron emission tomography (PET) and compare the imaging results between patients and healthy people.