[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645343":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":59,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":25,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Yale University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimodipine 1st \u002F Placebo 2nd","EXPERIMENTAL","Participants randomized to the Nimodipine 1st Arm will be administered Nimodipine prior to their 1st ADP session. Then after a washout period, participants will take a matching placebo prior to the 2nd lab session.",[13,14],"Drug: Nimodipine","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo 1st \u002F Nimodipine 2nd","Participants randomized to the Placebo1st Arm will be administered matching placebo prior to their 1st ADP session. Then after a washout period, participants will be administered Nimodipine prior to the 2nd lab session.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Nimodipine","Nimodipine 90mg\u002Fdose or matching placebo will be administered every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm). In total, participants will receive a total of 4 doses totaling to 360mg.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Matching placebo will be administered on the same schedule as Nimodipine, every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm).",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Suchitra Krishnan-Sarin","Yale University School of Medicine, Dept of Psychiatry","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Thomas Liss","CONTACT","2034447545","thomas.liss@yale.edu",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Nicholas Franco","2039745759","nicholas.franco@yale.edu",[46],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":25},"Yale University School of Medicine (Connecticut Mental Health Center)","New Haven","Connecticut","06519","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-72.92816,41.30815,{"lat":57,"lon":56},{"type":34,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},[61],{"name":62,"class":63},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100645343","phase-2-effects-of-nimodipine-on-alcohol-drinking-100645343",false,"NCT07681869","Effects of Nimodipine on Alcohol Drinking","A Randomized Controlled Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers","Inclusion Criteria:\n\n1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).\n2. Ability to read English at 6th grade level or higher.\n3. Meet DSM-V criteria for at least moderate AUD.\n4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the alcohol drinking paradigm (ADP).\n\nExclusion Criteria:\n\n1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.\n2. Meet current DSM-V criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.\n3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines, and barbiturates.\n4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation.\n5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.\n6. Medical conditions that would contraindicate the consumption of alcohol or use of nimodipine including untreated or not adequately controlled hypertension or hypotension. Blood pressure at or below 100\u002F65 will be exclusionary.\n7. Heart rate of less than 50 bpm.\n8. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \\> 3 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine \\>2.0 times ULN.\n9. Concurrent use of the following medications: CYP3A4 inhibitors and inducers, other calcium channel blockers, or other blood pressure lowering medications.\n10. Neurological trauma or disease, delirium, or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and PI, may put the patient at risk because of participation in the study.\n11. Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.\n12. Women who are pregnant or nursing.\n13. Participants who refuse to use a reliable method of birth control from the time of first medication administration to 7 days after. These include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring, surgical sterilization, or true abstinence.\n14. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n15. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n16. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.\n17. Subjects who have donated blood within the past 6 weeks.\n18. Heart rate of less than 50 bpm.\n19. Subjects with a history or presence of cirrhosis.\n20. MRI contraindications including incompatible implants, other metal in body (e.g. pacemakers, shrapnel, metal implants) or claustrophobia.","ALL","21 Years","50 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg\u002Fdose) or placebo every six hours during an 18-hour period prior to each ADP. MEG and\u002For EEG data will be collected before the first dose and after the third dose of nimodipine (NIM) or placebo (PLA). Adverse events will be closely monitored during this period. During the ADP participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as breath alcohol levels. Investigators anticipate having to recruit up to 40 participants to achieve 20 completers.",[82],"Alcohol Use Disorder","NOT_YET_RECRUITING","2026-06-25",{"date":86,"type":87},"2026-07-02","ACTUAL",{"date":89,"type":76},"2026-09-01",{"date":91,"type":76},"2032-06-30",{"name":5,"class":6},1]