[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Parnassia Addiction Research Centre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100479972","phase-2-efficacy-and-safety-of-sustained-release-dexamphetamine-in-patients-with-moderate-to-severe-cocaine-use-disorder-100479972",false,"NCT05529927","Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder","Efficacy and Safety of 24 Weeks Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder With Comorbid Opioid Use Disorder - A Multicenter Randomized, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n* male and female patients between 18 years and over;\n* actively participating in opioid agonist treatment with oral methadone;\n* with moderate or severe cocaine use disorder according to DSM-5;\n* with regular use of cocaine in the previous month (i.e., ≥8 days\u002Fmonth);\n* with snorting, inhaling or injecting cocaine use as primary route of administration;\n* express the intention to reduce or stop their cocaine use;\n* be able and willing to attend the treatment center for 2 days per week;\n* be able and willing to co-operate with the required study assessments and study procedures; and\n* have provided written informed consent.\n\nExclusion Criteria:\n\n* severe medical (e.g., severe renal or hepatic insufficiency\u002Ffailure) or severe psychiatric problems (e.g. previous or acute severe psychotic episode, acute suicidality, current bipolar disorder);\n* cardiovascular problems: clinically relevant ECG abnormalities suggestive of channelopathy or structural or ischemic heart disease, or a prolonged QTc interval (≥500 msec); moderate to severe hypertension (i.e., SBP\\>140; DBP\\>90); HR\\>100, known coronary artery disease (i.e., angina pectoris, acute myocardiac infarction), known cardiomyopathy, CVA;\n* glaucoma;\n* Gilles-de-la-Tourette syndrome;\n* pheochromocytoma;\n* hyperthyroid status;\n* pregnancy or continued lactation;\n* use of monoamine oxidase inhibitor(s) (MAOI): currently or in the past 14 days;\n* treatment with other prescription psychostimulants that might potentially be effective for stimulant use disorder (i.e., (immediate release) dexamphetamine, lisdexamphetamine, methylphenidate, or modafinil);\n* anticipated need for inpatient treatment (clinical judgement);\n* (expected) inability to complete the 30 weeks study (e.g., planned holidays, expected incarceration or hospitalization);\n* insufficient command of the Dutch language; and\n* current participation in another addiction treatment study.","ALL","18 Years",{"count":19,"type":20},204,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","In The Netherlands, each year, about 15 thousand people come into treatment because of problems with cocaine use. There is no approved medication for treatment of cocaine addiction and the psychosocial treatment patients receive is not successful for everyone; many return to treatment several times. There is evidence that agonist (\"replacement\") medications are effective in treating addiction: methadone for heroin addiction; nicotine replacement for smokers. Dexamphetamine is a stimulant medication registered for treatment of ADHD. It may also be effective as agonist treatment for people with cocaine addiction.\n\nIt will be investigated whether sustained-release dexamphetamine in people with cocaine addiction, participating in routine methadone maintenance treatment for their comorbid opioid use disorder, (1) reduces cocaine use and (2) improves their health and quality of life.",[26],"Cocaine Use Disorder",[28,29,30,31,32,33,34,35],"cocaine use disorder","sustained-release dexamphetamine","agonist pharmacotherapy","opioid use disorder","methadone maintenance treatment","randomized controlled trial (RCT)","placebo-controlled","double-blind","RECRUITING","2026-05-26",{"date":39,"type":40},"2026-05-29","ACTUAL",{"date":42,"type":40},"2026-04-22",{"date":44,"type":20},"2029-10",{"name":46,"class":47},"Parnassia Addiction Research Centre","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100503511","rewards-for-cannabis-abstinence-study-100503511","NCT05836207","Rewards for Cannabis Abstinence-study","The Cost-effectiveness of Contingency Management Compared to Standard Cognitive Behavioral Treatment for Treating Cannabis Use Disorder in Youth: A Randomized Controlled Trial","RECAB","Inclusion Criteria:\n\n* Youths (16-22 years) seeking treatment for a primary CUD\n* Regular cannabis use (≥14 days) in past 4 weeks\n* Intention to cease cannabis use during intervention\n* Able and willing to attend the treatment center and submit urine samples under supervision twice-weekly\n* Informed consent.\n\nExclusion Criteria:\n\n* Health contra-indications (e.g., acute psychosis\u002Fsuicidality)\n* Insufficient Dutch language.","16 Years","22 Years",{"count":60,"type":20},154,[62],"NA","The goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (CM) compared with Cognitive Behavioural Therapy (CBT) for the treatment of cannabis use disorder (CUD) in youth (16-22 years).\n\nThe main questions it aims to answer are:\n\n* What is the efficacy of 12 weeks outpatient CM versus CBT in youths with a CUD, in terms of cannabis abstinence during the intervention period?\n* What is the long-term efficacy of CM versus CBT at 6- and 12-months follow-up (FU)?\n* What is the cost-effectiveness of CM versus CBT at 12-months FU from a societal perspective?\n\nStudy hypotheses are:\n\n1\\. CM will result in more cannabis-abstinent days than CBT during the intervention; 2. CM is more effective and cost-effective than CBT at 12 months follow-up.\n\nEligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient CM or CBT. Assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. Primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. Key secondary endpoint: Treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline.\n\nThe primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates.\n\nCost-effectiveness and cost-utility analysis (CEA; CUA) will be performed from a societal perspective. CEA: Treatment response is the central clinical endpoint for calculations of incremental costs per responder. CUA: Incremental costs per QALY (based on EuroQoL).",[65],"Cannabis Use Disorder",[67,68,69,70,71,72,33],"contingency management","cognitive behavioural therapy","CM","CBT","cost-effectiveness","youth","2025-07-29",{"date":75,"type":40},"2025-07-31",{"date":77,"type":40},"2023-11-21",{"date":79,"type":20},"2027-09",{"name":46,"class":47},5,""]