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68 Ketamine Trials Near You
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerKetamine for Bipolar Depression
Ohio City, Ohio
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine, with an interventional component of fMRI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Pregnancy, Substance Use, Others
Must Not Be Taking:Benzodiazepines, Others
20 Participants Needed
Ketamine for Acute Pain
Akron, Ohio
This will be an intent to treat prospective, double blind, double-dummy, randomized trial. Our primary objective is the reduction of side effects of sub dissociative dose ketamine given by slow intravenous (IV) infusion over 30 minutes vs. 15 minutes in the treatment of acute, severe pain in Emergency Department (ED) patients. The secondary objective will be to maintain adequate pain control (as defined by a Visual Analog Scale (VAS) score of ≤ 5cm) at 30 minutes for both groups.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnant, Unstable Heart Disease, Others
Must Not Be Taking:Opiates, Alcohol, Others
48 Participants Needed
Ketamine for Aortic Aneurysm Pain Management
Lexington, Kentucky
This trial is testing low doses of ketamine to see if it can reduce pain and the need for opioids in patients having a specific type of heart surgery. These patients usually need a lot of pain relief because they are also getting another treatment to prevent a serious complication. Ketamine works by blocking pain signals in the brain. Ketamine is an old anesthetic agent that has been explored for pain relief in various conditions, including cancer pain and acute pain episodes.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Hydrocephalus, Pregnancy, Others
Must Be Taking:Naloxone
20 Participants Needed
Morphine or Ketamine for Pain
Pittsburgh, Pennsylvania
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:6 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Schizophrenia, Pregnancy, Others
Must Be Taking:Morphine
1010 Participants Needed
Ketamine for Postoperative Pain
Pittsburgh, Pennsylvania
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Schizophrenia, Hypertension, Others
Must Not Be Taking:Lamotrigine, Alfentanil
765 Participants Needed
Ketamine for Postpartum Depression
Pittsburgh, Pennsylvania
The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics.
The peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Psychosis, Hypertension, Others
Must Not Be Taking:Psychedelics, Antipsychotics
50 Participants Needed
Magnesium and Ketamine for Post-Operative Pain After Hysteroscopy
Royal Oak, Michigan
Hysteroscopy (an exam to look inside the uterus) is one of the most frequently performed procedures for patients with cervical or uterine disorders. It is the gold standard for evaluating various intrauterine problems, pre-menopausal and post-menopausal abnormal uterine bleeding, as well as being a vital examination modality for infertility work-up. Although hysteroscopy is a minimally invasive procedure, it is still known to be a painful experience that requires effective analgesia (meaning pain reduction) to achieve maximum patient comfort and cooperation. Historically, opioids, particularly fentanyl, have held precedence as the primary agents for providing analgesia following surgery of this type. However, despite their efficacy, these agents come with notable drawbacks, including the potential for serious side effects such as respiratory depression, addiction, and postoperative nausea and vomiting.
Both magnesium and ketamine are routinely used to reduce pain following this procedure. Both drugs work on the N-methyl-D-aspartate (NMDA) receptor in the brain to reduce pain, and magnesium has an additional effect in that it can relax smooth muscles. Magnesium has been used successfully to reduce the pain associated with menstrual cramps, which is similar to the pain patients experience after hysteroscopy.
A recent study demonstrated the benefits of adding intravenous magnesium with routine anesthesia during hysteroscopy, revealing a significant decrease in postoperative pain and rescue analgesics. However, this study did not compare the effects of magnesium to ketamine, nor did they characterize the nature of the patients' pain. It is unclear if the pain reduction with magnesium comes from its effect on the NMDA receptor or from it's cramp-reduction effect. We seek to establish whether administering IV magnesium, compared to ketamine, can specifically mitigate uterine cramping pain and total opioid consumption in hopes of finding additional safe and effective pain modalities for patients.
This is a prospective, randomized trial enrolling participants undergoing an elective hysteroscopy or Dilation and Curettage (D\&C) at Corewell Health William Beaumont University Hospital in Royal Oak. Participants will be randomized to 1 of 3 treatments: Intravenous (IV) Magnesium, IV Push Ketamine, or Placebo. Opioid consumption is recorded via the electronic medical record (EMR), while overall pain and cramping pain will be captured post-procedure in the hospital and 24 hours later via a phone call.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Chronic Pain, Psychiatric Disorders, Allergies, Others
Must Not Be Taking:Magnesium, Analgesics, Antidepressants, Opioids
150 Participants Needed
This trial tests a new way to help children with broken bones feel less pain during treatment. Instead of using a painful method, doctors will give a mix of two medications through the nose. This method aims to make the experience less distressing and more comfortable for children.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:2 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Psychosis, Hypertension, Others
400 Participants Needed
Ketamine vs Lidocaine for Rib Fractures
Grand Rapids, Michigan
Rib fractures continue to be a common occurrence in trauma patients of all ages. Traumatic rib fractures can cause severe pain in patients and lead to shallow breathing and further complications such as the need for mechanical ventilation, hospital or ventilator associated pneumonia, atelectasis, and acute respiratory distress syndrome. Effective multimodal pain management is needed to optimize a patient's respiratory status and can also play a role in early mobility, less pulmonary complications, shorter ICU and hospital length of stay, and decreased mortality. Current multimodal pain management options include opioids, muscle relaxants, gabapentin, acetaminophen, nonsteroidal anti-inflammatory drugs, and various regional/neuraxial anesthesia techniques. Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of opioids. However, there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures. Therefore, the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Psychosis, Glaucoma, Others
Must Not Be Taking:Antiarrhythmics
74 Participants Needed
Hydroxynorketamine for Neuropathic Pain
Chicago, Illinois
The goal of this randomized double blind three way (1:1:1) cross over clinical trial is to evaluate the effectiveness and duration of analgesia of a single infusion of (2R,6R)-HNK 0.5mg/kg compared with ketamine 0.5mg/kg and saline with a 5-week interval between treatments on pain, pain qualities, physical function, pain interference, sleep disturbance and quality of life in subjects with neuropathic pain of the extremities.
The questions that this study will address are:
1. What is the analgesic efficacy of (2R,6R)-HNK on pain intensity and pain qualities in patients with chronic (\>3 month) neuropathic pain (NP).
2. What will be the effective duration of a single infusion of (2R,6R)-HNK in patients with NP.
3. Will (2R,6R)-HNK reduce pain related effects including interference in daily activities of life, sleep disturbances and change the qualities of pain reported by patients.
Participants will receive each of the three study drugs in a random order at 5-week intervals over a 15 week period. The drug will be administered as a 45-minute infusion.
Participants will complete quantitative sensory and pain evaluations and complete patient reported pain outcomes prior to receiving the first study drug and at 7, 14 and 21 and 35 days following study drug administration.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Illness, Fibromyalgia, Mental Illness, Others
25 Participants Needed
Ketamine and SGB for Traumatic Brain Injury
Chicago, Illinois
Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios.
Primary Objectives:
1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache;
2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD;
3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD;
4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance;
5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
Secondary Objectives:
1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site).
2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Dementia, Parkinson's, Bipolar, Others
175 Participants Needed
Ketamine for Intensive Care Unit Patients
Hamilton, Ontario
Sedation is given to intensive care unit (ICU) patients to treat discomfort, anxiety, agitation, and to help facilitate care, particularly when they require a breathing tube. Sedation is very commonly used in the ICU with North American data showing almost 40% of ICU patients get sedation to help when they are requiring a breathing machine. Various medications can be given intravenously to provide sedation in the ICU but there are side-effects associated with each such as decreasing a patient's own drive to breathe, and delirium or acute confusion, both of which are associated with worse outcomes. Also, most drugs used for sedation don't treat pain. As a result, many ICU patients are also given narcotics for pain control which can result in tolerance, dependence, and withdrawal. Ketamine is a sedating medication that also treats pain and is often used in the Emergency Department and in the Operating Room but for whatever reason is not commonly used in the ICU.
The investigators are proposing a study to examine the usefulness and safety of adding an intravenous infusion of ketamine to usual care in adult patients that are on a breathing machine in the ICU.
Study Methods The KANINE study is being done at hospitals across Ontario, Canada. It is a randomized controlled trial which means patients will be randomized (akin to a coin flip) to receive ketamine or usual care without ketamine. The study will be blinded which means that neither patients or the doctors will know if the patient is getting ketamine or not, those that get randomized to usual care without ketamine will get an intravenous solution that looks the same as the ketamine infusion. This is important to make sure the results aren't biased in any way. The investigators will include adult ICU patients on a breathing machine who are early in their ICU admission. As most patients will be unconscious, the investigators will ask substitute decision makers (families or caregivers) of patients for informed consent prior to the study commencing. Regardless of whether patients get randomized to ketamine or not, the investigators will make sure that all patients will be adequately sedated and have their pain managed as per usual care.
Setting This study will be performed in adult ICUs across Canada.
Population The investigators will include adults admitted to the ICU on a breathing machine for at least 24 hours (and fewer than 3 days). The investigators will exclude patients if: (i) they were admitted with a brain bleed, traumatic brain injury, or stroke; (ii) Admitted with uncontrolled high blood pressure; (iii) if they have a history of schizophrenia; (iv) if they have very bad liver failure; (v) if they are palliative or only for comfort care; (vi) if they are receiving a medication that causes paralysis, sometimes used in patients with very bad lung disease; (vii) if they have a tracheostomy which means a whole in their neck that they breathe through; (viii) if they are allergic to ketamine; (ix) if they've had a liver transplant in the last month; (x) if they are pregnant or breast-feeding.
Outcomes The investigators will follow all the study patients to see if their outcomes are different depending on whether they get randomized to ketamine or not. The investigators will capture how much time they are on the breathing machine, whether they survive or die, how long they stay in the ICU and whether they require a tracheostomy which is a procedure often done on patients who require the breathing machine over a prolonged period of time.
The investigators will also capture how often they get delirious and for those that get delirious how long it lasts for. The investigators will capture how much of other sedating medications study patients use such as antipsychotics and benzodiazepines. The investigators will capture outcomes such as how often study patients get post-traumatic stress disorder after leaving the ICU and how well their pain relief is addressed during their ICU stay. Finally, the investigators will capture side effects related to ketamine or other sedating drug use.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Brain Injury, Hypertension, Schizophrenia, Liver Failure, Others
Must Be Taking:Non-ketamine Sedatives
54 Participants Needed
Ketamine for Procedural Pain
Maywood, Illinois
This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).
Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:7 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Altered Mental Status, Pregnancy, Seizures, Others
108 Participants Needed
Opioid-Free Pain Management for Prostate Cancer Surgery
Winston-Salem, North Carolina
The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:40 - 75
Sex:Male
Key Eligibility Criteria
Disqualifiers:Metastatic Disease, Brain Metastases, Others
Must Not Be Taking:Narcotics
100 Participants Needed
Sedatives for Emergency Intubation
Winston-Salem, North Carolina
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Under 18, Pregnant, Prisoner, Trauma, Others
2364 Participants Needed
Ketamine vs Midazolam for Tobacco Use Disorder
Winston-Salem, North Carolina
This trial tests how different drugs affect smoking habits and cravings in people who are not trying to quit. Participants receive an injection of either ketamine, midazolam, dexmedetomidine, or a saltwater solution. The study aims to see if these drugs can help reduce cravings and withdrawal symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:21 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Pulmonary Disease, Coronary Artery Disease, Hypertension, Others
Must Not Be Taking:Psychoactive Drugs
52 Participants Needed
Ketamine for Chronic Daily Headache
Toronto, Ontario
Chronic daily headaches (CDH) poses a significant burden on patients, healthcare systems and the society. Intravenous (IV) ketamine infusion, an intervention that is widely available and scalable, can treat CDH by reversing receptor-mediated sensitization. This study is a multicenter, placebo-controlled, parallel group randomized trial with blinding of participants and observers with the goal of comprehensively assessing the effect of high-dose IV ketamine infusion (1 mg.kg-1.h-1 for six hours) on the frequency and intensity of headaches, mood, activity, sleep, quality of life and safety of ketamine for three months after the interventions. Use of validated questionnaires, wearable technology, a research team that includes investigators with expertise in studying ketamine and in evaluating treatments for CDH and pain syndromes are some of the unique features of this project.
Our study aims to prospectively assess the efficacy and safety of high-dose intravenous ketamine infusions compared to saline infusions in participants with CDH syndrome.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Renal Impairment, Hypertension, Others
Must Not Be Taking:Benzodiazepines, Antipsychotics, Opioids, Others
56 Participants Needed
Ketamine + Virtual Reality for Depression
Toronto, Ontario
Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people. There is therefore a need for new treatments which work quickly and effectively.
One such medication is called ketamine. Studies have shown that ketamine can treat symptoms of depression quickly. This quick action sets ketamine apart from many antidepressants that take weeks to show noticeable effects. One way that it may do this is by creating a transient sense or feeling of being separated from reality, such as seeing or hearing things that are not really there. Another way to create these same feelings is with virtual reality (VR), where a person can feel as though they are entering a 3-dimensional virtual computer-generated world by wearing a special headset or goggles with a computer inside.
In this study, all participants will receive standard ketamine treatments for depression. Half of the participants will also use a VR headset while receiving the ketamine treatments to see if ketamine and VR acting together provide a better treatment for symptoms of depression than ketamine alone.
This is a small pilot trial. The main purpose of this trial is to learn if it is possible to run a larger clinical trial comparing "ketamine and VR" with "ketamine alone", for adults with treatment-resistant depression. The researchers will study this by seeing how many participants take part in the study within 1-2 years, and how many complete the study treatments and tests. The researchers will also compare the two study groups to see if "ketamine and VR" provide a better treatment for symptoms of depression than "ketamine alone".
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychosis, Substance Misuse, Pregnancy, Others
Must Be Taking:IV Ketamine
31 Participants Needed
Psilocybin for Demoralization
Rockville, Maryland
This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Uncontrolled Hypertension, Pregnancy, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Dopamine Agonists, Others
100 Participants Needed
Ketamine for Depression
Bethesda, Maryland
Background:
Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.
Objective:
To see if the antidepressant response of ketamine is linked to AMPA receptors.
Eligibility:
Adults ages 18-70 with major depression disorder without psychotic features
Design:
Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam.
Participants will stay at the NIH Clinical Center for 5 weeks.
Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests:
* Blood draws
* Psychological tests
* MRI: Participants will lie in a machine that takes pictures of their brain.
* MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity.
* Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep.
* Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity.
For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Abuse, Serious Illnesses, Others
Must Not Be Taking:Opioids, MAOIs, Fluoxetine, Aripiprazole
70 Participants Needed
Ketamine for Major Depressive Disorder
Bethesda, Maryland
Background:
Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.
Objective:
Main Study: To study the effects of ketamine in treating depression.
Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry.
To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.
Eligibility:
Main Study: People ages 18-65 with major depressive disorder and healthy volunteers
Ketamine Metabolites Substudy: Healthy volunteers ages 18-65
Design:
Main Study:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.
Phase I (2-7 weeks):
* Gradually stop current medications
* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.
* Mood and thinking tests
* Blood and urine tests
* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.
* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.
* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.
Phase I tests are repeated in Phases II and III and in the final visit.
Phase II (4-5 weeks):
* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.
Phase III (optional):
* 8 infusions of ketamine over 4 weeks
Phase IV (optional):
* Symptoms monitoring for 4 weeks
* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.
Ketamine Metabolites Substudy:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 days.
Study Procedures:
Mood and thinking tests
Blood and urine tests
1 infusion of ketamine
Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Substance Abuse, Others
Must Not Be Taking:Reversible MAOIs, Opioids
150 Participants Needed
Negative Emotions Impact on Decision-Making
Bethesda, Maryland
Background:
Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.
Objective:
To learn how negative emotions affect the brain and decision-making behavior.
Eligibility:
Healthy people aged 18 to 55 years.
Design:
Participants will have 3 clinic visits in 3 weeks.
Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.
For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor:
Some participants will watch a video.
Some will have to do arithmetic problems.
Some will have heat applied to an arm or leg.
Some will experience cold by immersing their hand in ice water.
For a snack craving test, some will be tempted by food after a 4-hour fast.
During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.
After the stressors, participants will do tasks on a computer. They will need to make choices.
Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.
...
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Unstable Medical, Psychiatric, Substance-related, Pregnancy, Others
Must Not Be Taking:Psychoactive, Corticosteroids, Pain, Antidepressants
900 Participants Needed
Gabapentin + Ketamine for Head and Neck Cancer Pain Management
Nashville, Tennessee
This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:21+
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Schizophrenia, Others
Must Not Be Taking:Gabapentin, Ketamine
64 Participants Needed
Ketamine for Opioid Use Disorder
Baltimore, Maryland
The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are:
* Does ketamine reduce craving for opioids in patients with opioid use disorder?
* Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality?
* Do patients who take ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo?
Researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects of ketamine) to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder.
Participants will:
* Be given ketamine or a placebo 4 times over a period of 2 weeks
* Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Hypertension, Severe Mental Illness, Others
Must Be Taking:Methadone
50 Participants Needed
Ketamine for Multiple Sclerosis Fatigue
Baltimore, Maryland
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Depression, Untreated Sleep Apnea, Coronary Artery Disease, Others
Must Be Taking:Fatigue Medications
110 Participants Needed
Psychoactive Substances for Hallucinations
Baltimore, Maryland
The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:25 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiovascular Conditions, Epilepsy, Others
Must Not Be Taking:MAO Inhibitors, Serotonin Agents
50 Participants Needed
Ketamine-assisted Psychotherapy for PTSD
Madison, Wisconsin
The objectives of this study are to investigate the feasibility, tolerability, and preliminary efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three to six hours of integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:15 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychotic Disorder, Bipolar, Autism, Others
Must Not Be Taking:Benzodiazepines, Opiates, Lamotrigine
5 Participants Needed
Ketamine for Stroke
Wynnewood, Pennsylvania
This trial is testing if giving ketamine can help protect the brains of stroke patients by calming overactive nerve cells.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Psychiatric Illness, Hypertension, Others
120 Participants Needed
Ketamine for Treatment-Resistant Depression
Iowa City, Iowa
A single subanesthetic dose infusion of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has rapid and robust antidepressant effects in patients with treatment-refractory major depressive disorder (TRD). A family history of an alcohol use disorder (Family History Positive, FHP) is one of the strongest identified predictors of an improved antidepressant response to ketamine. Like ketamine, alcohol is a functional NMDA receptor antagonist. FHP is associated with differential response to ketamine, e.g. blunted psychotomimetic side effects. One of the primary mechanistic hypotheses for ketamine's antidepressant action is the acute intrasynaptic release of glutamate from major output neurons, e.g. cortical pyramidal cells. Preliminary clinical studies have demonstrated this acute glutamate "surge" in response to subanesthetic dose ketamine. Based on these findings, the investigators hypothesize that ketamine's enhanced antidepressant efficacy in FHP TRD subjects is, at least in part, attributable to increased glutamate release relative to TRD subjects without a family history of alcohol use disorder (Family History Negative, FHN). To test this hypothesis, the investigators have designed a now two-site, open-label study of 18-55-year-old medically and neurologically healthy, currently moderately-to-severely depressed TRD patients. In total, the investigators plan to recruit 25 FHP and 25 FHN TRD subjects. All subjects must not have a current substance use disorder (except nicotine or caffeine). The experimental portion consists of two phases. The preliminary first phase is a medication taper (if needed) and psychotropic medication-free period. The experimental second phase comprises one subanesthetic dose (0.5mg/kg x 40 minute) ketamine infusion. The ketamine infusion will occur during 7T-magnetic resonance imaging (MRI), both resting-state functional MRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) to detect glutamate in the ventromedial prefrontal cortex/ventral anterior cingulate cortex (vmPFC/vACC). The primary outcome measure is group mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from pre-ketamine infusion (baseline) to one-week post-infusion, where the investigators observed ketamine's greatest antidepressant effect in FHP TRD. Additional outcome measures are vmPFC/vACC glutamate change in response to ketamine based on family history status. In summary, this study will provide key mechanistic information on ketamine's improved antidepressant efficacy in a biologically-enriched subgroup. This will contribute to the systematic development of more efficacious, personalized treatments for major depression in an effort to reduce its enormous public health burden.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Use, Pregnancy, Others
Must Not Be Taking:SSRIs, SNRIs, Benzodiazepines, Antipsychotics
60 Participants Needed
Ketamine-Assisted Psychotherapy for Depression
New York, New York
This trial compares two treatments for adults with severe depression. One treatment uses ketamine combined with therapy, and the other uses only ketamine. Ketamine helps improve mood by changing brain chemistry, and therapy might make these improvements last longer. Ketamine, originally a dissociative anesthetic, has been increasingly used for treatment-resistant depression due to its rapid antidepressant effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Schizophrenia, Bipolar, Others
Must Be Taking:Antidepressants
70 Participants Needed
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Frequently Asked Questions
How much do clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.How do clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length is 12 months.How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.Do I need to be insured to participate in a medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.What are the newest clinical trials ?
Most recently, we added Morphine or Ketamine for Pain, Ketamine for Opioid Use Disorder and Ketamine and SGB for Traumatic Brain Injury to the Power online platform.Popular Searches
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