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16 Belsomra 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 PowerSuvorexant for Alcoholism
Lexington, Kentucky
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:21 - 55
Key Eligibility Criteria
Disqualifiers:Severe SUD, Psychiatric Diagnoses, Others
Must Not Be Taking:Chronic Condition Medications
30 Participants Needed
Suvorexant for PTSD-Related Sleep Disturbances
Salisbury, North Carolina
Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Severe Sleep Apnea, Others
Must Be Taking:SSRIs, SNRIs
144 Participants Needed
Suvorexant for Postoperative Delirium
Durham, North Carolina
This research study will evaluate the effectiveness of postoperative administration of a drug called suvorexant, to improve postoperative sleep and decrease the severity of delirium (serious confusion) in adults 65 years and older undergoing non-cardiac surgery.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:65+
Key Eligibility Criteria
Disqualifiers:Obesity, Psychotic Disorders, Liver Failure, Others
Must Not Be Taking:CYP3A Inhibitors, CYP3A Inducers, Sedating Sleep Aids
130 Participants Needed
Suvorexant for Insomnia
Charleston, South Carolina
Investigators propose a double-blind, placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Breast cancer survivors have an increased risk of insomnia for which Suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes. Breast cancer survivors with sleep disturbance based on an Insomnia Severity Index Score (ISI) \>15 will be randomized to either Suvorexant or placebo, with both arms receiving education on sleep hygiene.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Depression, Anxiety, Sleep Apnea, Others
Must Be Taking:Estrogen Modulators, Aromatase Inhibitors
44 Participants Needed
Suvorexant for Alzheimer's Disease
St. Louis, Missouri
The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:65+
Key Eligibility Criteria
Disqualifiers:Stroke, Chronic Kidney Disease, HIV/AIDS, Others
Must Not Be Taking:Sedatives, Suvorexant Interactors
200 Participants Needed
Suvorexant for Alcoholism
Bethesda, Maryland
Background:
Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.
Objective:
To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.
Eligibility:
People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.
Design:
Participants with AUD will stay in the clinic for at least 3 to 4 weeks for alcohol detoxification. They will receive normal treatment for AUD.
Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.
Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.
Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.
Imaging scans and other tests will be repeated at the end of the study.
Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.
...
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Severe Mental Illness, Severe Depression, Severe Hepatic Impairment, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Opioids, Others
150 Participants Needed
Sleep Medications for Healthy Volunteers
Silver Spring, Maryland
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Age:18 - 39
Key Eligibility Criteria
Disqualifiers:Sleep Disorders, Neurologic Disorders, Cardiovascular Disease, Psychiatric Disorder, Others
Must Not Be Taking:Sleep Aids, Benzodiazepines, Amphetamines, Others
90 Participants Needed
Suvorexant for Opioid Use Disorder
Baltimore, Maryland
This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Alcohol Use Disorder, Others
Must Be Taking:Buprenorphine/naloxone
120 Participants Needed
Suvorexant for Opioid Use Disorder
Baltimore, Maryland
This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:21 - 65
Key Eligibility Criteria
Disqualifiers:Serious Mental Illness, Stimulant Use, Pregnancy, Others
Must Be Taking:Methadone, Buprenorphine, XR-NTX
200 Participants Needed
Suvorexant for Opioid Use Disorder
Baltimore, Maryland
This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnant, Breastfeeding, Seeking Opioid Treatment, Others
75 Participants Needed
Belsomra + Methylphenidate for Smoking Cessation
Baltimore, Maryland
Study Description:
Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals.
Objectives:
The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm.
Endpoints:
In nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward/cognition as well as impacts the pharmacological influence of methylphenidate on those same measures.
Study Population:\<TAB\>
Nicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers/vapers.
Control arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers/vapers
This study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD.
Description of Study Intervention:
Nicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days.
Control arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)
Study Duration:
5 years
Participant Duration:
1-2 months
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Neurological Disorders, Obesity, Others
Must Not Be Taking:CNS Depressants, CYP3A Inhibitors
140 Participants Needed
Suvorexant for Sleep Disorders in ICU Patients
Bronx, New York
Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients ≥ 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:60+
Key Eligibility Criteria
Disqualifiers:Renal Failure, Liver Failure, Others
Must Not Be Taking:Benzodiazepines, Antidepressants
120 Participants Needed
Suvorexant for Insomnia
Houston, Texas
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:21 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Schizophrenia, Bipolar, Others
Must Not Be Taking:CYP3A Modulators
76 Participants Needed
Suvorexant for Stimulant Use Disorder
Houston, Texas
The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Opioid Use Disorder, Severe Diseases, Others
Must Not Be Taking:MAO Inhibitors, Anticonvulsants
20 Participants Needed
Suvorexant for Cannabis Use Disorder
Boston, Massachusetts
The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. Researchers think that suvorexant may reduce activity in certain parts of the brain associated with cannabis use. Researchers are studying if this medication does affect brain activity in these areas.
For this study, participants will be asked to complete four study visits over approximately 14 days. Each study visit will include interviews, questionnaires, and collection of biological samples for laboratory testing. All participants will be asked to take suvorexant, an FDA approved medication for treatment of insomnia, for 14 days. They will complete two one-hour functional Magnetic Resonance Imaging (fMRI) scans: one before starting the study medication and one after 14 days of taking the study medication. MRI is used in typical medical settings and is considered to be safe. Participants will also be asked to complete a short daily survey for approximately 14 days.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Unstable Illness, Neurological Disorders, Obesity, Others
Must Be Taking:Suvorexant
10 Participants Needed
Suvorexant for Sleep Issues in Children with Autism
Stanford, California
This trial is testing suvorexant, a sleep aid, in children and adolescents with Autism Spectrum Disorder who have sleep problems. Suvorexant helps people fall asleep and stay asleep by blocking wakefulness signals in the brain.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:13 - 17
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Seizure Disorder, Severe Hepatic Insufficiency, Others
Must Not Be Taking:Beta-blockers, Benzodiazepines, Antiepileptics, Others
26 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
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 Suvorexant for Cannabis Use Disorder, Suvorexant for Insomnia and Suvorexant for Alcoholism to the Power online platform.Popular Searches
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