[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592556":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":64,"centralContacts":68,"locations":77,"responsibleParty":97,"collaborators":99,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":49,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":49,"overallStatus":79,"whyStopped":49,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Northeastern University","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Moderate drinking technologies with \"lower tech\" facilitation","EXPERIMENTAL","Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with \"lower tech\" facilitation.",[13,14,15],"Device: Alcohol-related mobile health technologies","Behavioral: Motivational interview and psychoeducation on blood\u002Fbreath alcohol concentration","Behavioral: Lower tech facilitation",{"label":17,"type":10,"description":18,"interventionNames":19},"Moderate drinking technologies with \"higher tech\" facilitation","Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with \"higher tech\" facilitation",[13,14,20],"Behavioral: Higher tech facilitation",{"label":22,"type":23,"description":24,"interventionNames":25},"Alcohol Education Condition","ACTIVE_COMPARATOR","Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text",[26,27],"Behavioral: Alcohol Education","Device: Alcohol Education Technology",[29,38,45,50,56,60],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Alcohol-related mobile health technologies","Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.",[17,9],[35,36,37],"Smartphone Breathalyzer","BAC Estimator App","Self-Texting App",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BEHAVIORAL","Motivational interview and psychoeducation on blood\u002Fbreath alcohol concentration","Brief 25\u002F30-minute motivational interview and psychoeducation on blood\u002Fbreath alcohol concentration that includes both personalized and standardized information.",[17,9],[44],"M.I.",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Lower tech facilitation","Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.",[9],null,{"type":39,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Higher tech facilitation","Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.",[17],[55],"SmartSip",{"type":39,"name":57,"description":58,"armGroupLabels":59,"otherNames":49},"Alcohol Education","Brief 25\u002F30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources",[22],{"type":30,"name":61,"description":62,"armGroupLabels":63,"otherNames":49},"Alcohol Education Technology","Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session",[22],[65],{"name":66,"affiliation":5,"role":67},"Robert F Leeman, Ph.D.","PRINCIPAL_INVESTIGATOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":49,"email":73},"Jade Martinez, B.S.","CONTACT","(617) 373-5132","ja.martinez@northeastern.edu",{"name":75,"role":71,"phone":49,"phoneExt":49,"email":76},"Allie Farone, M.S.","a.farone@northeastern.edu",[78],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RECRUITING","Boston","Massachusetts","02115-5005","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-71.05977,42.35843,{"lat":89,"lon":88},[92,94,95],{"name":70,"role":71,"phone":93,"phoneExt":49,"email":73},"617-697-7169",{"name":75,"role":71,"phone":49,"phoneExt":49,"email":76},{"name":96,"role":67,"phone":49,"phoneExt":49,"email":49},"Robert F Leeman, PhD",{"type":98,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[100],{"name":101,"class":102},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100592556","multi-component-breath-alcohol-intervention-phase-3-100592556",false,"NCT06994962","Multi-Component Breath Alcohol Intervention Phase 3","Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3","BAMTECH","1. Be between the ages of 18-25\n2. Be able to read English and complete study evaluations\n3. Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days\n4. Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.\n5. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)\n6. Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.\n\nExclusion Criteria\n\nNo subject may:\n\n1. Have been in inpatient or intensive outpatient treatment within the past 12 months\n2. Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months\n3. Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.\n4. History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.\n5. Be psychotic or otherwise severely psychiatrically disabled\n6. Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders).",true,"ALL","18 Years","25 Years",{"count":116,"type":117},90,"ESTIMATED","INTERVENTIONAL",[120],"NA","This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood\u002Fbreath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling\u002Fpsychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.",[123,124,125],"Alcohol Use","Alcohol Drinking","Drinking Behavior","2026-05-18",{"date":128,"type":129},"2026-05-20","ACTUAL",{"date":131,"type":129},"2025-05-01",{"date":133,"type":117},"2027-01-31",{"name":5,"class":6},1]