[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05929677":3,"trial-entities:NCT05929677":128,"trial-summary:NCT05929677":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":47,"secondary_outcomes":66,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":90,"locations":92,"central_contacts":121,"overall_officials":123,"references":126,"see_also_links":127},"NCT05929677","71127","Impulsivity Domains and Subjective Response","Linking Impulsivity Domains and Subjective Response to Alcohol in Young Adults Using Lab and Daily Assessment Methods","RECRUITING","2027-09-01","2026-05","2026-05-22","2024-04-01","Jessica Weafer","OTHER",false,"Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults.","Young adult alcohol misuse is an urgent, growing public health crisis, as young adults have the highest alcohol use disorder rates of any age group with rates increasing in young women. Interventions for this population are hampered by small effects, few options and lack of tailoring to salient risk factors. A recent review in Addiction argued that research informing interventions fails to account for the complexity of relationships among factors contributing to young adult alcohol misuse. These needs will be addressed by examining relationships between two cardinal etiologic risk factors: impulsivity and subjective response to alcohol (SR). Despite theoretical and biological links between them, little is known about relations between the two risk factors, or how associations between them may promote young adult alcohol misuse longitudinally and on a momentary or daily basis. Prior theory and evidence linking impulsivity and positive, rewarding alcohol effects have been primarily learning and expectancy based. Here, based on exciting preliminary results, the researchers posit an inherent, biological link between impulsivity and high-risk SR (elevated stimulation and dampened sedation). This research is nascent with multiple gaps in knowledge. These gaps will be addressed by examining impulsivity pre-drinking, SR and alcohol use in a lab setting and via seven 10-day daily assessment periods over 2 years using ecological momentary assessment (EMA) (N=250, 50% female). Using self-report and both lab and mobile tasks, the investigators will characterize 3 unique, established impulsivity domains: poor inhibitory control, delay discounting and negative urgency. SR will be assessed at successive breath alcohol levels using precision intravenous (IV) methods in the lab, followed by opportunity to self-administer more IV alcohol. SR will also be measured at roughly comparable, estimated blood alcohol levels via daily EMA methods. This design enables testing of SR early in a drinking event as a predictor of in-lab and daily alcohol use, along with alcohol use and consequences over time, plus SR's potential role as a mediator of impulsivity\u002Falcohol relations. Recent findings indicate daily changes in impulsivity predict subsequent drinking and consequences. These types of changes are challenging to capture with lab methods only. Daily measures also enable modeling of both person-level individual differences and daily, within-subject effects. However, there are no published studies relating daily impulsivity and SR measures. In this study, investigators will: 1) determine relations between lab-based impulsivity and SR; 2) determine relations between daily impulsivity and SR; and 3) relate impulsivity and SR to alcohol misuse longitudinally.\n\nResearchers hypothesize impulsivity will relate to heightened stimulation and less sedation following alcohol and that SR will partially mediate relations between impulsivity and alcohol misuse. Evidence of links between specific impulsivity domains and SR longitudinally and on a momentary\u002Fdaily basis will point to specific intervention targets to ameliorate two critical vulnerability factors for young adult alcohol misuse. Thus, investigators will: 1) identify mechanisms of alcohol action and 2) facilitate prevention and treatment research: two NIAAA priority areas.\n\nFindings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults. As such, the project is directly relevant to NIAAA's mission to identify mechanisms of alcohol action and facilitate prevention and treatment research.",[19],"Alcohol Use Disorder",[21,22,23,24,25,26],"Addiction","Alcohol","Young adult","Impulsivity","Prevention","Subjective response","INTERVENTIONAL","BASIC_SCIENCE",[30],"EARLY_PHASE1",{"count":32,"type":33},250,"ESTIMATED",[35,44],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"DRUG","Placebo","Participants receive placebo (saline) intravenously. They will also have the opportunity to self-administer saline during the 60-minute free-access IV self-administration period in session 3.",[40,41],"Alcohol, Then Placebo, then Free-access session","Placebo, Then Alcohol, then Free-access session",[43],"Saline",{"type":36,"name":22,"description":45,"armGroupLabels":46},"Participants receive alcohol intravenously, clamped at BrACs of 20mg%, 40mg%, and 60mg%. They will also have the opportunity to self-administer alcohol (up to 120mg% BrAC) during the 60-minute free-access IV self-administration period in session 3.",[40,41],[48,52,56,60,63],{"measure":49,"description":50,"timeFrame":51},"Lab Subjective Response to Alcohol (SR)","Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation\u002Fsedation).","70 minutes",{"measure":53,"description":54,"timeFrame":55},"Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)","Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation\u002Fsedation) using the EMA app.","10 days",{"measure":57,"description":58,"timeFrame":59},"Change in Breath Alcohol Concentration (BrAC)","Highest BrAC in mg% taken by breathalyzer during the free-access period","60 minutes",{"measure":61,"description":62,"timeFrame":59},"Number of alcohol drink units self administered","participants can self-administer alcohol infusions by pushing 1 of 2 buttons to receive an alcohol or water \"drink\" unit. Each alcohol \"drink\" targets a 7.5mg% increase in BrAC over 2.5 min. The water \"drink\" is an equal volume of saline.",{"measure":64,"description":65,"timeFrame":55},"Number of drinks per day","Participants will report the number of drinks they consume each day via EMA app added to their phone.",[],"ALL","21 Years","25 Years",true,{"inclusion":72,"exclusion":77,"raw_text":89},[73,74,75,76],"21-25 years old","Report drinking to an estimated BAC \\> .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB)","Report drinking at least twice weekly in the past 30 days based on responses on the TLFB","Fluency in English",[78,79,80,81,82,83,84,85,86,87,88],"Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)","Body weight \\\u003C 110 or \\> 210 pounds","Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder","Current alcohol withdrawal or history of medically-assisted detoxification","Two positive breath alcohol concentration (BrAC) readings (i.e., \\> 0.00%) at an in-person screening appointment or experimental session","Positive urine screen for illegal drugs other than cannabis","Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors","Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days","Psychosis or other psychiatric disability","Pregnancy, nursing or lack of reliable birth control use for women","Report smoking \\> 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)","Inclusion Criteria:\n\n* 21-25 years old\n* Report drinking to an estimated BAC \\> .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB)\n* Report drinking at least twice weekly in the past 30 days based on responses on the TLFB\n* Fluency in English\n\nExclusion Criteria:\n\n* Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)\n* Body weight \\\u003C 110 or \\> 210 pounds\n* Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder\n* Current alcohol withdrawal or history of medically-assisted detoxification\n* Two positive breath alcohol concentration (BrAC) readings (i.e., \\> 0.00%) at an in-person screening appointment or experimental session\n* Positive urine screen for illegal drugs other than cannabis\n* Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors\n* Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days\n* Psychosis or other psychiatric disability\n* Pregnancy, nursing or lack of reliable birth control use for women\n* Report smoking \\> 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)",[91],"ADULT",[93,108],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":105},"Northeastern University","Boston","Massachusetts","02115","United States",[100],{"name":101,"role":102,"phone":103,"email":104},"Robert Leeman","CONTACT","617-373-6501","r.leeman@northeastern.edu",{"lat":106,"lon":107},42.35843,-71.05977,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":98,"contacts":113,"geoPoint":118},"Ohio State University","Columbus","Ohio","43221",[114],{"name":115,"role":102,"phone":116,"email":117},"Jessica Weafer, PhD","614-257-2075","jessica.weafer@osumc.edu",{"lat":119,"lon":120},39.96118,-82.99879,[122],{"name":115,"role":102,"phone":116,"email":117},[124],{"name":115,"affiliation":109,"role":125},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[130],"Alcohol use disorder",[],{"nct_id":4,"found":70,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This interventional study plans to enroll 250 participants. It involves receiving either a placebo or alcohol intravenously.","completed","Understanding Alcohol Use Disorder in Young Adults","This study is looking at how impulsivity and your body's response to alcohol are connected in young adults, which could help create better ways to prevent and treat Alcohol Use Disorder (AUD). You might receive either a placebo (saline) or alcohol intravenously (through a vein) during the study. Researchers will measure your subjective response (how you feel) to alcohol and your breath alcohol concentration (BrAC). To join, you need to be 21-25 years old, drink alcohol at least twice a week, and have had a blood alcohol level over 0.08% at least once in the past month. The study aims to understand these connections to find new targets for treatment. The current recruitment status is unclear.","Your subjective response to alcohol will be measured at 70 minutes and again after 10 days. Your breath alcohol concentration will be measured for 60 minutes.",116,"You would receive either saline or alcohol intravenously. In one session, you would also have the chance to self-administer saline or alcohol for 60 minutes.","Not stated in the trial record.",[37,22],"v2"]