[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05778734":3,"trial-entities:NCT05778734":141,"trial-summary:NCT05778734":145},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":93,"minimum_age":94,"maximum_age":95,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":112,"locations":114,"central_contacts":127,"overall_officials":132,"references":135,"see_also_links":140},"NCT05778734","2022-1047","StuDy AimED at Increasing AlCohol AbsTinEnce","StuDy AimED at Increasing AlCohol AbsTinEnce (DEDICATE)","RECRUITING","2028-04-30","2026-05","2026-05-07","2023-07-30","University of Illinois at Chicago","OTHER",null,"The goal of this clinical trial is to test the feasibility \\& acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD).\n\nThe aims are as follows:\n\nK99 Aim: Test feasibility \\& acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews.\n\nR00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male\u002Ffemale young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months.\n\nR00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning \\& analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.","Study Design Formative (K99 Phase), we will test feasibility \\& acceptability of integrated CM-PST. To test CM-PST, we will recruit\u002Fenroll 20 participants in a single-arm pre\u002Fpost study. Participants who meet eligibility will be invited to our clinical lab at UIC for informed consent and baseline measures. Consenting participants will receive CM-PST intervention via videoconferences such as zoom, in 8 CM-PST individual sessions, every week for sessions 1-4 and every other week for sessions 5-8, over 12 weeks. Participants will complete the Client Satisfaction Scale survey after each session and 3 mo. post-intervention, to quantify their overall experiences with this new CM-PST.\n\nPreliminary efficacy trial (R00 Phase). This will be a 2-arm Randomized control trial in young adults aged 18-24 yr who meet AUD criteria. Prospective participants who respond to our advertisements will be screened by phone for eligibility and to determine their AUD diagnostic status and severity (mild, moderate, severe). Participants who meet eligibility will be invited to our UIC clinical lab for informed consent, baseline self-report measures, urine alcohol screening, and baseline fMRI, and then randomized to either CM-PST (42 participants) or CM-only (42 participants) control group. All participants will complete follow-up assessments at 3 \\& 6 months with blinded outcome assessors.",[19],"Alcohol Use Disorder",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},104,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","CM-PST","CM-PST is a tailored behavioral intervention that enables young adults with AUD to successfully manage and overcome everyday life challenges influencing their alcohol intake.",[34],"Treatment group",{"type":30,"name":36,"description":37,"armGroupLabels":38},"CM only","CM is a behavior therapy that rewards individuals for evidence of positive change (alcohol abstinence).",[39],"Control group",[41],{"measure":42,"description":43,"timeFrame":44},"Alcohol abstinence.","Participants will be monitored for 6 months to assess alcohol abstinence by blood alcohol content.","Up to 6months",[46,50,54,58,62,65,68,70,72,74,78,81,84,86,88,90],{"measure":47,"description":48,"timeFrame":49},"Change in AUD severity at 3 months.","Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 3 months.","Baseline, 3months.",{"measure":51,"description":52,"timeFrame":53},"Change in AUD severity at 6 months.","Measured by Alcohol Use Disorder and Associated Disabilities Interview Schedule-5. Change in AUD severity from baseline to 6 months.","Baseline, 6months.",{"measure":55,"description":56,"timeFrame":57},"Change in AUD screening status.","Measured by AUDIT. Participants will be monitored for up to 6 months. This is the number of participants who screen positive for AUD.","Up to 6months.",{"measure":59,"description":60,"timeFrame":61},"Change in Alcohol-related negative consequences at 3 months.","Measured by Rutgers Alcohol Problem Index (RAPI).","Baseline, 3 months.",{"measure":63,"description":60,"timeFrame":64},"Change in Alcohol-related negative consequences at 6 months.","Baseline, 6 months.",{"measure":66,"description":67,"timeFrame":61},"Change in Alcohol use at 3 months.","Measured by 90-day Timeline Followback (TLFB).",{"measure":69,"description":67,"timeFrame":64},"Change in Alcohol use at 6 months.",{"measure":71,"description":67,"timeFrame":61},"Change in Drug use at 3 months.",{"measure":73,"description":67,"timeFrame":64},"Change in Drug use at 6 months.",{"measure":75,"description":76,"timeFrame":77},"Change in Reasons for drinking at 3 months.","Measured by Drinking Motives Questionnaire Revised (DMQ-R).","Baseline, 3 months",{"measure":79,"description":76,"timeFrame":80},"Change in Reasons for drinking at 6 months.","Baseline, 6 months",{"measure":82,"description":83,"timeFrame":77},"Change in negative affect at 3 months.","Measured by Positive and Negative Affect Schedule (PANAS).",{"measure":85,"description":83,"timeFrame":80},"Change in negative affect at 6 months.",{"measure":87,"description":83,"timeFrame":77},"Change in positive affect at 3 months.",{"measure":89,"description":83,"timeFrame":80},"Change in positive affect at 6 months.",{"measure":91,"description":92,"timeFrame":61},"Change in Neural target engagement of positive affect. affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex).","Measured by Functional magnetic resonance imaging (fMRI).","ALL","18 Years","24 Years",true,{"inclusion":98,"exclusion":104,"raw_text":111},[99,100,101,102,103],"Male and female young adults aged 18-24 yr","English-speaking","Current alcohol use greater or equal to 1 day\u002Fweek via phone screening, and meet criteria for (past year) mild, moderate or severe AUD on the AUDIT and AUDADIS surveys.","Completion of written informed consent","Baseline screening study visit.",[105,106,107,108,109,110],"Participation in past 6 mo. in AUD or substance use treatment","Current use of medications used to treat AUD (e.g., naltrexone)","Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder.","Current use of psychoactive drugs, determined by positive drug toxicology screen","Conditions (e.g., tic disorder) that would interfere with psychophysiological indices of reward functioning","Pregnancy or intention to become pregnant","Inclusion Criteria:\n\n* Male and female young adults aged 18-24 yr\n* English-speaking\n* Current alcohol use greater or equal to 1 day\u002Fweek via phone screening, and meet criteria for (past year) mild, moderate or severe AUD on the AUDIT and AUDADIS surveys.\n* Completion of written informed consent\n* Baseline screening study visit.\n\nExclusion Criteria:\n\n* Participation in past 6 mo. in AUD or substance use treatment\n* Current use of medications used to treat AUD (e.g., naltrexone)\n* Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder.\n* Current use of psychoactive drugs, determined by positive drug toxicology screen\n* Conditions (e.g., tic disorder) that would interfere with psychophysiological indices of reward functioning\n* Pregnancy or intention to become pregnant\n* Additional exclusion criteria pertaining to fMRI scan in R00 phase only: a) bodily ferrous metals (e.g., aneurysm clips, shrapnel\u002Fretained particles) or b) claustrophobia, inability to tolerate small enclosed spaces.",[113],"ADULT",[115],{"facility":13,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":124},"Chicago","Illinois","60608","United States",[121],{"name":122,"role":123},"Hagar Hallihan","CONTACT",{"lat":125,"lon":126},41.85003,-87.65005,[128],{"name":129,"role":123,"phone":130,"email":131},"Hagar Hallihan, PhD","312-413-5361","hhalli2@uic.edu",[133],{"name":122,"affiliation":13,"role":134},"PRINCIPAL_INVESTIGATOR",[136],{"pmid":137,"type":138,"citation":139},"40829841","DERIVED","Hallihan H, Lee S, Rospenda KM, Wu Y, Adomah R, Knepper A, Ma J. Feasibility and acceptability of contingency management and problem-solving therapy intervention for enhancing alcohol abstinence: a single-arm, mixed methods pilot clinical trial. BMJ Open. 2025 Aug 19;15(8):e098691. doi: 10.1136\u002Fbmjopen-2024-098691.",[],{"nct_id":4,"conditions":142,"biomarkers":144},[143],"Alcohol use disorder",[],{"nct_id":4,"found":96,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This study has two parts: a formative part with 20 participants in a single-arm study, and a preliminary efficacy part with 84 participants in a randomized control trial.","completed","Study Aimed at Increasing Alcohol Abstinence","This study is testing two behavioral therapies for young adults (ages 18-24) with Alcohol Use Disorder (AUD). One therapy is called CM-PST, which helps young adults manage daily challenges that affect their drinking. The other is CM only, which rewards individuals for not drinking alcohol. The study wants to see if CM-PST is practical and acceptable, and if it works better than CM alone to help people stop drinking. Success will be measured by how well participants achieve alcohol abstinence for up to six months. The study is currently unclear about its recruitment status.","Participants will have follow-up assessments at 3 and 6 months after the intervention.",94,"Participants will have 8 individual sessions over 12 weeks, either weekly or every other week, via video conference. They will also complete satisfaction surveys and follow-up assessments.","Not stated in the trial record.",[31,36],"v2"]