[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-use-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-use-disorders":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,75,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100603023","can-selfcompassion-training-reduce-alcohol-consumption-in-patients-with-alcohol-use-disosrder--100603023",false,"NCT07131124","Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ?","Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? Randomized Controlled Trial","COMPAL","Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Subjects meeting DSM-5 criteria for Alcohol Use Disorder (AUD).\n* Subjects receiving outpatient care in addiction services, CSAPA, CMP, day hospitals, mental health care institutions, community mental health centers.\n* Subjects affiliated with the social security system.\n* Subjects who have a good understanding of French languague, allowing them to provide informed consent, respond to self-questionnaires, and participate in the MSC program.\n\nExclusion Criteria:\n\n* Subjects unable to understand the questionnaires.\n* Subjects presenting moderate or severe suicidal ideation (assessed by the Suicide item of the MINI scale).\n* Subjects with a score \\\u003C10 on the MoCA version 7.1 test.\n* Subjects admitted to inpatient units (since hospitalization alters alcohol consumption).\n* Subjects unable to provide informed or voluntary consent to participate in the study.\n* Subjects under guardianship or curatorship.","ALL","18 Years","75 Years",{"count":21,"type":22},152,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this interventional study is to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population of individuals with Alcohol Use Disorder (AUD), six months after the intervention. The MSC program was designed to enhance self-compassion skills. It has demonstrated a mediating effect on symptoms of stress, depression, and anxiety, which are known to contribute to the maintenance of AUD.\n\nOutpatients with AUD will be included after providing informed consent and will be randomized into two groups (MSC+TAU vs TAU). The follow-up includes 13 visits over a 9-month period, with group sessions according to allocation. Three follow-up visits are scheduled up to six months after the end of the sessions. Participants will complete several scales and surveys (AUDIT, TLFB, SCS, HAD, SSS-S, TOSCA-3, AQoLS, MAAS, Fagerström, CUDIT-R, EVA craving).",[28,29,30,31],"Addiction","Addiction Disorders","Alcohol Use Disorders","Alcohol Dependence",[33,30],"Self-compassion","NOT_YET_RECRUITING","2025-08-12",{"date":37,"type":38},"2025-08-20","ACTUAL",{"date":40,"type":22},"2025-10",{"date":42,"type":22},"2027-10",{"name":44,"class":45},"Etablissement Public de Santé Barthélemy Durand","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100596367","development-of-a-novel-peer-recovery-supporter-training-platform-100596367","NCT07044531","DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM","DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE","Inclusion Criteria: Eligible participants will be prospective PRSS providers residing in the U.S., ages 18 and over, with at least one year of continuous sobriety.\n\n\\-\n\nExclusion Criteria: We will exclude individuals with eligibility questionnaire responses indicating: (a) an inability to read or speak English; (b) active suicidal ideation (PHQ-9, Item 9); (c) severe anxiety (GAD-7 \\>15); (d) significant medical illnesses, and; (e) unable to complete the baseline assessment or unavailable for computer and telephone follow-ups over the approximately ten month study period.\n\n\\-",{"count":55,"type":22},120,[25],"The focus of this study is to assess the effect on Peer Recovery Support Service providers of the fully asynchronous training platform (TDPP) and the TDPP with live zoom sessions on skill and adherence compared with training-as-usual.",[59,30,60,61],"Substance Use Disorders","Recovery Support Services","Peer Recovery Coaching",[63,61,30,59],"Peer Recovery Support Services","RECRUITING","2025-07-21",{"date":67,"type":38},"2025-07-22",{"date":69,"type":38},"2025-05-07",{"date":71,"type":22},"2026-07",{"name":73,"class":74},"Thrive Digital Health, LLC","INDUSTRY",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":95,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100576742","co-occurence-of-mental-illness-and-problematic-alcohol-use-an-internet-based-cognitive-behavior-therapy-intervention-100576742","NCT06789250","Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention","CoMiT","Inclusion Criteria:\n\n* Age ≥18 years\n* AUDIT ≥ 6 points for women and ≥ 8 points for men\n* Symptoms of depression, anxiety disorder and\u002For stress-related illness\n* Adequate ability to speak, read and write Swedish\n* Having access to the internet and a smartphone, computer or other device.\n\nExclusion Criteria:\n\n* Ongoing psychological treatment.\n* Ongoing medication for AUD\n* Recent changes (within the past three months) in psychiatric medication or planned changes during the treatment period. New medication prescribed during the study shall be reported but will not lead to exclusion\n* Severe psychiatric disorders based on a Mini-International Neuropsychiatric Interview (MINI) interview and reported medical history\n* Severe medical conditions that may impede participation in the study\n* Severe cognitive impairment\n* Current suicidality\n* Severe alcohol addiction where specialized treatment is more appropriate\n* Risk for severe alcohol withdrawal symptoms with a need for medical treatment. Participation is possible after completing alcohol withdrawal treatment within the ordinary health-care system, accessible to the Swedish population.\n* Substance use disorder, other than alcohol or nicotine, within the past six months.",{"count":83,"type":22},240,[25],"The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep.\n\nThe main questions the study aims to answer are:\n\n* Does the ICBT program lower the self-rated suffering from mental illness?\n* Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days.\n\nParticipants are adults living in Sweden. They will:\n\n* Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants.\n* Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment.\n\nPrimary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.",[87,30,88,89,90,91,92,93,94],"Alcohol Drinking Related Problems","Depressive Disorders","Mental Illness","Mental Stress","Mental and Behavioral Disorders","Sleep Problems","Stress Disorders","Anxiety Disorder\u002FAnxiety State",[96,97,98,99,100,101,102,103,104,105,106],"Internet intervention","Depression","Anxiety","Individually tailored","Transdiagnostic","Internet-based cognitive behavioral therapy (ICBT)","Stress","Sleeping disorders","Mental illness","Harmful alcohol use","Alcohol addiction","2025-02-21",{"date":109,"type":38},"2025-02-24",{"date":111,"type":38},"2025-01-05",{"date":113,"type":22},"2026-05",{"name":115,"class":116},"Linkoeping University","OTHER_GOV",2,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":17,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100571411","phase-1-a-phase-i-study-of-the-interaction-of-alcohol-with-oral-afa-281-in-healthy-volunteers-100571411","NCT06719908","A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers","A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers","Inclusion Criteria:\n\n* Adults between 21 and 55 years of age, inclusive.\n* Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.\n* Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.\n* Body mass index (BMI) within the range of 18.5 to 30.0 kg\u002Fm2, inclusive.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit\n* Adequate venous access\n* Must be surgically sterile (vasectomy, tubal ligation or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm, for 90 days after study drug administration.\n* Agree to abstain from strenuous exercise during the inpatient stay of the study.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug.\n* Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 430 msec.\n* Has an estimated creatinine clearance (CrCl) outside of normal range.\n* History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.\n* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n* Requirement for any over-the-counter and\u002For prescription medication, vitamins and\u002For herbal supplements on a regular basis.\n* Use of any medications, vitamins and\u002For herbal supplements within the 2-week period prior to study drug administration.\n* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.\n* Display any latent signs of alcohol withdrawal per the Clinical Institute Withdrawal of Alcohol Assessment-Revised (CIWA-AR).\n* History or current diagnosis of a substance use disorder.\n* Positive urine drug screen for drugs of abuse at Screening or Day -1.\n* Consumption of alcohol within the 1-day period prior to study drug administration.\n* Receipt of any drug by injection within 30 days prior to study drug administration.\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.\n* History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.\n* Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.\n* Pregnant or nursing women\n* Receipt of any investigational product within 6 weeks prior to study drug administration.\n* Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration.\n* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.\n* Current enrollment in another clinical study.\n* Previous enrollment in this study.\n* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive AFA-281.",true,"21 Years","55 Years",{"count":129,"type":22},20,[131],"PHASE1","The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.\n\nParticipants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.",[134,30],"Alcohol",[136,134,137,138],"AFA-281","Ethanol","Healthy Volunteer","2024-12-02",{"date":141,"type":38},"2024-12-06",{"date":143,"type":22},"2025-07-01",{"date":145,"type":22},"2029-09-01",{"name":147,"class":74},"Afasci Inc"]