[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"naltrexone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:naltrexone":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100439843","early-phase-1-understanding-how-opioids-affect-the-experiential-and-neural-signatures-of-social-experiences-100439843",false,"NCT05007561","Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences","Inclusion Criteria:\n\n* good health\n* English fluency\n* willing to provide contact information for 4-6 close others\n* willing to provide digital photographs of 2 close others\n* own a smartphone\n\nExclusion Criteria:\n\n* presence of medical devices, implants, or other metal objects in or on the body that cannot be removed\n* tattooed eyeliner\n* a body habitus prohibiting MRI scanning\n* claustrophobia\n* self-reported chronic mental or physical illness\n* current and regular use of prescription medication\n* previous history of having difficulty taking pills\n* current use of opioid analgesics\n* depressive symptoms above a 9 on Patient Health Questionnaire\n* excessive alcohol use\n* positive urine drug test\n* body mass index (BMI) greater than 35\n* pregnancy or plans to become pregnant in next 6 months\n* positive urine pregnancy test",true,"ALL","18 Years","25 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.",[27,28],"Naltrexone","Placebo","RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2021-11-16",{"date":37,"type":21},"2027-07",{"name":39,"class":40},"San Diego State University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100512658","phase-2-effectiveness-of-low-dose-naltrexone-in-patients-with-different-types-of-vulvodynia-100512658","NCT05955313","Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia","Effectiveness of Low-doses of Naltrexone (LDN) on Pain Perception and Quality of Life in Women With Vulvodynia","Inclusion Criteria:\n\n1. Women from the age of 18 to the menopause or to the age of 50 (on the day of inclusion for testing).\n2. Patients who are not pregnant and do not plan to become pregnant in the next 9 months from the inclusion in the study\n3. Signing the patient's informed and voluntary consent to participate in the study.\n4. General health of the patient (WHO = 0-2).\n5. Diagnosis of vulvodynia.\n6. Negative drug test found at the visit randomization.\n7. Documented correct cytology result from 3 years ago (before the visit screening).\n8. Stable dose of drugs acting on the central nervous system used min. 1 month before the screening visit and during the entire patient's participation in the study.\n9. Acceptance or readiness to use a highly effective method of contraception from the screening visit throughout the study. Sexual abstinence is not accepted.\n10. The ability to understand the principles of testing and operating electronic devices.\n\nExclusion Criteria:\n\n1. Severe, hepatic and renal dysfunction defined as:\n\n   i. An ASPT or ALT result 5 times the upper limit; ii. The level of bilirubin 3 times above the upper limit of normal - excluding patients with Gilbert's syndrome; iii. EGFR result below 30 ml \u002F min \u002F m2, on the basis of historical studies not older than 3 years before the screening visit or from the tests performed during the screening visit according with point 12 of the Protocol, version 1.0 of March 28, 2022.\n2. Abuse of alcohol (more than 14 units per week) and other stimulants. 3. Taking psychoactive substances, including drugs, except for SSRI, SNRI, SARI (Trazodone), and anticonvulsants (Gabapentin, Pregabalin, Lamotrigine) in fixed doses from the screening visit.\n\n4\\. Taking opioid drugs in the last 2 months before the screening visit (also in OTC preparations, eg Loperamide).\n\n5\\. Taking naltrexone hydrochloride and Mysimba for weight loss at any time in your life.\n\n6\\. BTA injection in the vulva in the last 4 months before the screening visit. 7. Endovascular procedures in the area of the small pelvis in the last 6 months before the screening visit.\n\n8\\. Previous surgical procedures requiring general anesthesia (with general anesthesia) in the last 2 months before the screening visit.\n\n9\\. Completed multidisciplinary therapeutic program in the treatment of vulvodynia in the last 4 months before the screening visit.\n\n10\\. Diseases of the vulva: lichen, current contact vulvovaginitis, bacterial and \u002F or yeast infections, other dermatological diseases, recurrent genital herpes (HSV; min 4 times \u002F year).\n\n11\\. Diagnosis of current or past serious mental disorders according to the criteria of ICD-10 and DSM-5, including psychotic and organic disorders (except depression and anxiety disorders).\n\n12\\. Gynecological abnormalities requiring medical treatment: current HSIL, CIN II \u002F III, pelvic inflammation, mixed or solid ovarian tumors, simple ovarian cysts greater than 5 cm, abnormal vaginal inter-cycle bleeding.\n\n13\\. Pelvic venous diseases (PeVD), 4 criteria met on USG. 14. Pregnancy and lactation. 15. Spastic diseases: multiple sclerosis (MS), connective tissue diseases (Marfan syndrome and marfan-like syndromes), reactive arthritis (RA). 16. Vaginismus, Lamont scale 3-5 (gynecological examination impossible due to anxiety).\n\n17\\. Significant and \u002F or uncorrected disability in the field of sight or hearing, making it difficult to perform psychological tests.","FEMALE","50 Years",{"count":52,"type":21},300,[54],"PHASE2","Vulvodynia (Vd) is chronic functional vulvar pain, with prevalence of 3-16% and unclear etiopathology. Although Vd significantly deteriorates quality of life, the problem is marginalized, no pharmacologic treatment standards exist. Naltrexone hydrochloride is a specific opioid antagonist with slight agonist activity. There is growing body of evidence supporting the effectiveness of low-dose naltrexone (LDN) in different types of chronic pain. The main goal of this trial is to test the effect of LDN on pain perception and quality of life in women with different types of Vd. Half of the study population receives LDN and the remaining patients take placebo, according to randomization list. This RTC is quadruplet blinded.",[57,27,58],"Vulvodynia","Quality of Life",[60,61,62],"vulvodynia","low dose naltrexone","quality of life","2023-07-12",{"date":65,"type":33},"2023-07-21",{"date":67,"type":33},"2023-05-31",{"date":69,"type":21},"2026-12-31",{"name":71,"class":40},"Medical University of Lublin"]