169 Clinical Trials for Various Conditions
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
The social cognitive deficits associated with autism spectrum disorder (ASD) are related to an imbalance in excitatory and inhibitory neurotransmission, specifically a deficit in the inhibitory neurotransmitter GABA. The investigators have used magnetic resonance spectroscopy (MRS) techniques to measure GABA in specific brain regions and have demonstrated that a single dose of gabapentin increases GABA in brain regions associated with social cognition. This study will use a biomarker-driven approach to investigate gabapentin to correct the underlying imbalance of neurotransmitters and improve the core social cognitive deficits in ASD. By using a brain-based biomarker (GABA) that is quantifiable and measurable, the investigators can target this biomarker directly and measure the impact of the treatment. This will help with the future development of targeted therapies for ASD and provide an early marker of response to aid in the selection of individuals more likely to respond to various treatments. The specific aims of this study are to: 1) determine if treatment with gabapentin sustainably increases GABA in the right anterior insula (RAI; an area of the brain involved in social cognition), 2) determine if response of RAI GABA levels to a single dose challenge of gabapentin predicts a sustained response after treatment, and 3) determine if the increase in GABA levels with gabapentin treatment translates into clinically measurable improvement in social cognition. The investigators will conduct an 8-week open-label clinical trial of gabapentin in 40 adolescents (age 13-17 years) with ASD, using MRS before and after treatment to measure GABA in the RAI (the primary outcome for the study). Before the trial, a single dose challenge of gabapentin will be used to evaluate the immediate response of GABA levels in the RAI, to determine if this predicts later response. A secondary outcome will be the clinical effects of gabapentin on social cognition. This study can demonstrate for the first time that neuroimaging biomarkers can be used to guide treatment of social cognition deficits seen in ASD and that the excitatory-inhibitory imbalance in neurotransmitters in ASD can be pharmacologically targeted. This can provide a rational basis for pharmacological treatment of the core social deficits of ASD, providing direct benefit to participants in the study as well as indirect benefit to countless patients in the future.
This study aims to determine if administration of gabapentin preoperatively followed by a standing postoperative course is effective in reducing and possibly eliminating the use of opioid analgesics following this procedure. As a secondary outcome, it will evaluate the possible improvement in post tonsillectomy pain control with the use of a standing dose of gabapentin.
This study is a double-blind, randomized, prospective, placebo-controlled single-center clinical research study in which 600 mg of gabapentin or placebo will be administered 2 hours preoperatively to 49 patients each undergoing wisdom teeth extraction. We will measure intraoperative opioid use, severity of pain, the number of analgesics taken, and side effect profiles (e.g. nausea/vomiting, dizziness) at the following intervals, 4 hour, 8 hour, 12 hour, 24, and 72 hour post-procedure.
This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.
Sleep disruption in the intensive care unit (ICU) is a common comorbidity associated with patient morbidity and distress. There are no recommended pharmacologic interventions for sleep promotion, and many pharmacologic solutions may actually increase the risk of adverse outcomes rather than impart benefits. Gabapentin, an anticonvulsant with applications in neuropathic pain, has been investigated for sleep promotion in various populations of outpatients. Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. Outcomes measured will be sleep quality as measured by RCSQ (Richards-Campbell Sleep Questionnaire), wrist actigraphy, EEG, and BIS monitoring. The goal is to enroll 80 critically ill patients, 40 intubated and 40 non-intubated patients. The study will take place over 2 nights, with baseline sleep measurements occurring on the first night and gabapentin administration with repeat sleep measurements on the second night.
This is a double-blind, placebo-controlled, randomized, crossover trial aimed at assessing the effect of gabapentin and tizanidine, two pain medications, on insomnia in chronic pain patients.
The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.
Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.
Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E. To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.
The purpose of this study is to determine the best strategy of administering gabapentin in connection with our current approach to perioperative pain management. We aim to evaluate two different adjunct gabapentin regimens given in the perioperative period, and to identify which manages patient pain more effectively and safely. In this evaluation, we will identify the quantity of patients' opioid consumption, the quality of their pain management, and the frequency and severity of any side effects they might experience. Patients who are undergoing total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group using computer-generated randomization. Patients in group 1 (the control group) will receive the standard of care as pertains to gabapentin. This consists of a single 600 mg dose of gabapentin administered to the patient approximately one to two hours before surgery, then a dose of 600 mg each morning during postoperative admission. Patients in Group 2 will receive 600 mg preoperatively, plus an additional postoperative gabapentin regimen: they will take 300 mg of gabapentin every 8 hours for 1 week, then a single nightly dose of 300 mg for another month.
Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them. The investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures. The main goals of our study are to learn about: 1. Women's pain experience with dilators in their cervix overnight before the abortion procedure 2. How well gabapentin works to decrease women's pain while they have the dilators in their cervix Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care. The investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking. The investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it). The investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.
The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be completed.
The purpose of this study is to assess the effectiveness of pre-operative administration of gabapentin 900 mg in management of acute post-operative pain in patients undergoing oral and maxillofacial surgical procedures.
There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.
The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial. After completion of the 1-week double-blind phase, subjects will be offered open-label gabapentin with rescue metoclopramide until their symptoms no longer require treatment. Enrollment will occur at the University's at Buffalo, of Rochester and of Wisconsin.
The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.
Although some studies show improvement of pain and associated effects of pain with off-label use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published evidence so far. We propose to complete a year-long prospective, observational study as a pilot to recruit 400 patients within the year and follow their pain level, function, and QOL measures for 16 weeks to determine whether it is feasible to continue studying this group in the future. We expect that pain, function, and quality of life will be improved in the group of patients who are given neuropathic agents as an adjunct to other conservative treatments compared to the expected 65% of patients with similar symptoms who are treated conservatively without neuropathic agents. We do not expect a statistically significant difference between the two neuropathic agents. Since these drugs are currently used off-label, there is limited empirical evidence regarding which agent is more efficacious compared to the other, and since their use in treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or the other of these agents has been based on likely compliance (medication needed twice a day, three times a day) or whether or not the patients' insurance will pay for one or the other. This study will be a first step to better assist practitioners in counselling their patients on use of these medications in radiculopathy, examining rates of discontinuation due to side effects and what effects these medications have on perceived pain, function and quality of life.
The purpose of this study is to evaluate the patient experience when using gabapentin with other pain control medications after posterior spinal fusion surgery for scoliosis in adolescents. These results will be compared to patients who underwent the same procedure during the study period and received the same standardized pain control regimen excluding gabapentin. Effects on pain level, opioid use, and satisfaction will be measured. Opioid side effects including nausea, sedation and urinary retention (inability to empty one's bladder) will also be recorded.The null hypotheses are as follows: 1. There is no significant difference in pain control when adding gabapentin to a multimodal pain management protocol in pediatric post-operative posterior spinal fusion patients. 2. There is no significant difference in the amount of opioid medication required for pain control in pediatric post-operative posterior spinal fusion patients.
This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.
The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in patients' use of hydrocodone-acetaminophen.
In this open-label, pilot study the investigators will be assessing gabapentin's effects on insomnia and other concussion-related symptoms in patients with a recent concussion experiencing insomnia.
This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.
The standard approach to sedation in endoscopic retrograde cholangiopancreatography (ERCP) involves the use of benzodiazepines and opiates to achieve a moderate depth of sedation. There is data to suggest supplementing this regimen with gabapentin may lead to reduced pain, higher patient satisfaction and lower opiate requirements. The investigators are conducting a clinical trial to study this hypothesis.
Primary Hypotheses: 1. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method. Secondary Hypotheses: 1. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.
The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving medications clonidine and gabapentin to see if they decrease the amount of opioid pain medications needed after surgery, thereby reducing opioid-related side effects, and time required to return to normal activities of daily living after surgery.
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.
The purpose of this research study is to evaluate the drug gabapentin (Neurontin®) for its ability to reduce postoperative pain, the need for morphine-like pain medication, and the severity and frequency of postoperative nausea and vomiting in laparoscopic gastric bypass surgery patients.