[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617949":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":105,"collaborators":30,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":30,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":30,"enrollmentInfo":115,"targetDuration":30,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":30,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Apremilast 60 mg\u002Fday","ACTIVE_COMPARATOR","Apremilast, 30mg per capsule, administered twice daily (AM\u002FPM), Placebo, administered once daily (AM)",[13],"Drug: Apremilast",{"label":15,"type":10,"description":16,"interventionNames":17},"Oral Apremilast 90 mg\u002Fday","Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM)",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Oral Matched Placebo","PLACEBO_COMPARATOR","Placebo, capsule, 2 capsules (AM) and 1 capsule (PM)",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Placebo","Matched Placebo Capsule",[19],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Apremilast","30 mg capsule",[9,15],[36],"Otezla",[38],{"name":39,"affiliation":5,"role":40},"Daniel Falk, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":30,"email":46},"Megan Ryan, MBA","CONTACT","3014434225","mryan1@nih.gov",[48,69,85],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of California","RECRUITING","Los Angeles","California","90095","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-118.24368,34.05223,{"lat":60,"lon":59},[63,67],{"name":64,"role":44,"phone":65,"phoneExt":30,"email":66},"Jessica Jenkins, MS","310-206-6756","jenkinsj@ucla.edu",{"name":68,"role":40,"phone":30,"phoneExt":30,"email":30},"Lara Ray, PhD",{"facility":70,"status":50,"city":71,"state":72,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University of Colorado","Aurora","Colorado","80045",{"type":57,"coordinates":75},[76,77],-104.83192,39.72943,{"lat":77,"lon":76},[80,83],{"name":81,"role":44,"phone":30,"phoneExt":30,"email":82},"Kristen Raymond","kristen.raymond@cuanschutz.edu",{"name":84,"role":40,"phone":30,"phoneExt":30,"email":30},"Joseph Schacht, PhD",{"facility":86,"status":50,"city":87,"state":88,"zip":89,"country":54,"countryCode":55,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Virginia","Charlottesville","Virginia","22911",{"type":57,"coordinates":91},[92,93],-78.47668,38.02931,{"lat":93,"lon":92},[96,100,103],{"name":97,"role":44,"phone":98,"phoneExt":30,"email":99},"Eva Jenkins-Mendoza, BS","434-243-0562","emj9c@hscmail.mcc.virginia.edu",{"name":101,"role":44,"phone":102,"phoneExt":30,"email":30},"Tracie Kostelac","434.243.0563",{"name":104,"role":40,"phone":30,"phoneExt":30,"email":30},"Nassima Ait-Daoud Tiouririne, MD",{"type":106,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100617949","phase-2-human-laboratory-study-of-apremilast-for-alcohol-use-disorder-100617949",false,"NCT07325266","Human Laboratory Study of Apremilast for Alcohol Use Disorder","Inclusion Criteria (not exhaustive list):\n\n1. Be at least 21 years of age.\n2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).\n3. Have a BAC by breathalyzer equal to 0.000 when s\u002Fhe signed the informed consent document (either just prior to or immediately after signing consent).\n4. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.\n5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.\n6. Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:\n\n   * oral contraceptives,\n   * contraceptive sponge,\n   * patch,\n   * double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal),\n   * intrauterine contraceptive system,\n   * etonogestrel implant,\n   * medroxyprogesterone acetate contraceptive injection,\n   * complete abstinence from sexual intercourse, and\u002For\n   * hormonal vaginal contraceptive ring.\n7. Be willing to adhere to the investigational product dosing schedule.\n8. Complete all assessments required at screening and baseline.\n9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s\u002Fhe will lose his\u002Fher housing by Study Week 6.\n10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6.\n11. Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.\n12. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment.\n13. Be someone who in the opinion of the investigator would be expected to complete the study protocol.\n14. Agree to the schedule of visits, verbally acknowledge that s\u002Fhe will be able to attend each scheduled visit, participate in phone visits and that s\u002Fhe does not have any already scheduled events or a job that may substantially interfere with study participation.\n15. If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:\n\n    * SSRIs\n    * Dual uptake inhibitors\n    * SNRIs\n    * Tricyclic antidepressants\n    * MAOIs\n    * Bupropion\n16. Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.\n17. Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.\n\nExclusion Criteria:\n\nContact study site for exclusion criteria","ALL","21 Years",{"count":116,"type":117},100,"ESTIMATED","INTERVENTIONAL",[120],"PHASE2","Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.\n\nSecondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.",[123,124],"Alcohol Use Disorder","Alcohol Misuse","2026-04-30",{"date":127,"type":128},"2026-05-01","ACTUAL",{"date":130,"type":128},"2026-04-03",{"date":132,"type":117},"2027-07-31",{"name":5,"class":6},3]