[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stimulant-use-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stimulant-use-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,70,95,124,153,176,204,230,260],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100540975","phase-2-mirtazapine-for-the-treatment-of-methamphetamine-use-in-opioid-use-disorder-patients-receiving-medication-assisted-treatment-100540975",false,"NCT06323837","Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment","A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial (RCT) to Evaluate the Ability of Mirtazapine (MZP) to Increase Methamphetamine (MA) Abstinence Among Treatment-seeking Medication for Opioid Use Disorder (MOUD) Adults","MIRROM","Inclusion Criteria:\n\n* Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery \\& Treatment Center\u002Fclinics in Spokane, WA.\n* Verification of a DSM-5104 diagnosis of an methamphetamine (MA) use disorder (i.e. mild, moderate, or severe),\n* Aged 18+ years,\n* Ability to provide written informed consent,\n* Demonstration of 78% adherence rate during the induction period and\n* Provision of at least one MA positive urinalysis at baseline or during induction.\n* Baseline complete blood cell count (CBC), total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history.\n* No current acute illness requiring prolonged medical care.\n* No serious chronic illnesses that are likely to progress clinically during trial participation.\n* Vital signs are within the normal ranges (i.e., Blood pressure: 90\u002F60 mm Hg to 120\u002F80 mm Hg; breathing: 12-18 breaths per minute; pulse: 60-100 beats per minute; temperature: 97.8 - 99.1 degrees Fahrenheit.\n\nExclusion Criteria:\n\n* Inability to demonstrate competency to provide informed consent because of cognitive or psychiatric disorders or limited English proficiency,\n* Prior diagnosis of dementia,\n* Medically or psychiatrically unsafe to participate as determined by Dr. Layton (Medical Director),\n* Documented suicide attempt in the past 30 days and\u002For serious suicide intention or plan as assessed by the Structured Clinical Interview for DSM-5 (SCID-5; clinical trials version)105\n* Suicide attempt in the last 2 years\n* Moderate or severe liver disease (AST, ALT, and total bilirubin \\>= 5 times upper limit of normal),\n* Impaired renal function (estimated GFR \\\u003C40 ml\u002Fmin),\n* Current severe cocaine, amphetamine, or alcohol use disorder as defined by DSM-5 criteria which Drs Layton and McPherson deem their participation as unsafe.\n* History of bipolar disorder or psychotic disorder, as determined by Structured Clinical Interview for DSM Disorders (SCID,\n* Currently taking 1) any type of opioid use disorder medication other than methadone or buprenorphine\u002Fnaloxone, or 2) phenytoin, carbamazepine, or another inducer of hepatic metabolism (such as rifampicin) and CYP enzyme inhibitor cimetidine.\n* Taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamine oxidase inhibitor,\n* Prescribed MZP in the least year, or\n* History of violent criminal behavior or being on parole,.\n* Currently pregnant or intending to become pregnant,.\n* Final determination of eligibility will be made by Dr. Layton in consultation with the PI.",true,"ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).\n\nThe investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods.",[28],"Stimulant Use Disorder","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2024-06-17",{"date":37,"type":22},"2026-12-01",{"name":39,"class":40},"Washington State University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100512866","reset-for-the-treatment-of-stimulant-use-in-hiv-clinics-care-optimization-supporting-treatment-adherence-costa-100512866","NCT05958017","reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)","COSTA","Inclusion Criteria:\n\n1. Assigned male sex at birth and has not undergone any transgender hormonal treatment\n2. Reports having had sex with a male in the past 12 months\n3. Age 18 or older\n4. Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located\n5. Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI\n6. Reports that he is not currently in drug treatment\n7. Is living with HIV\n8. Reports having an active antiretroviral prescription\n9. Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet\n10. Able to understand English\n11. Consents to participation in the study\n12. Provides sufficient locator information\n13. Identifies as non-Hispanic White, non-Hispanic Black\u002FAfrican American or Latinx\u002FHispanic\n14. Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months\n\nExclusion Criteria:\n\n1. Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).\n2. Persons that meet criteria for prisoner status will be excluded at baseline.\n3. Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred to community-based programs that provide specialized treatment for this disorder.\n4. Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.","MALE","90 Years",{"count":52,"type":22},260,[54],"NA","The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.",[28,57],"People Living With HIV",[59,60],"Substance use","Adherence to Anti-Retroviral Therapy","2026-06-15",{"date":63,"type":33},"2026-06-17",{"date":65,"type":33},"2025-03-04",{"date":67,"type":22},"2028-01-31",{"name":69,"class":40},"University of Miami",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100603426","restore-study-r61-phase-recovery-and-engagement-for-stimulant-users-on-re-entry-100603426","NCT07136363","RESTORE Study R61 Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE Study R61 Pilot Phase: Recovery and Engagement for Stimulant Users on Re-entry","RESTORE","Inclusion Criteria:\n\n* Be 18 years of age or older\n* Have a DSM-5 diagnosis of stimulant use disorder (methamphetamine and\u002For cocaine)\n* Be at risk for or living with HIV\n* Be transitioning to the community from a closed justice setting, such as:\n\nJail Prison Justice-mandated residential substance use program\n\n* Be able to provide informed consent\n* Be willing and able to use a smartphone app (DynamiCare)\n\nExclusion Criteria:\n\n* Severe medical or psychiatric disability making participation unsafe\n* Unable to provide consent or engage with the intervention",{"count":79,"type":22},40,[54],"Justice-involved individuals face disproportionately high rates of stimulant use disorder and HIV, along with disrupted access to HIV treatment and prevention services like ART and PrEP. Contingency management (CM) is the most effective intervention for stimulant use, but its use in justice-involved populations has been limited by logistical and structural barriers. DynamiCare is an FDA-approved mobile app that delivers behavioral CM and has shown promise in reducing stimulant use, but its impact on HIV-related outcomes remains unknown. The RESTORE study (Recovery and Engagement for Stimulant Users on Re-entry) will evaluate whether combining DynamiCare with patient navigation (DynamiCare-plus) improves PrEP\u002FART initiation and reduces stimulant use among individuals recently released from justice settings. The R61 phase will assess feasibility, acceptability, and preliminary effectiveness among 40 participants. If milestones are met, the R33 phase will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost. This scalable, mobile approach has the potential to address a critical gap in care for a highly vulnerable population.",[83,28,84,85],"HIV","Justice Involved Populations","HIV Prevention","2026-06-12",{"date":61,"type":33},{"date":89,"type":33},"2026-06-01",{"date":91,"type":22},"2027-07-31",{"name":93,"class":40},"University of Texas Southwestern Medical Center",2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":111,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":41},"100593048","emotional-brain-training-for-addiction-medicine-treatment---a-pilot-study-100593048","NCT07001371","Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study","Inclusion Criteria:\n\n* Age 18 years old or older\n* Patient can speak and read English\n* Patient who receives regular MAT care at SAC Health\n* Patients who have regular and reliable cellular and\u002For reliable internet connection\n* Patients who are willing to spend average of 25 minutes per day and attend weekly group meetings\n* Patients willing to actively participate in group sessions\n* Opioid use disorder, at least in early remission\n* Alcohol use disorder, at least in early remission\n* Methamphetamine use disorder, at least in early remission\n* Cocaine use disorder, at least in early remission\n* Anxiolytic use disorder, at least in early remission\n* Cannabis use disorder\n* Tobacco use disorder\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* Patient does not speak or read English\n* Patients who do not seek regular MAT care at SAC Health\n* Patients with inconsistent or no access to cellular or internet connection\n* Any disorder that is uncontrolled\n* Any substance use disorder not in at least early remission\n* Any patient with complications related to use disorder\n* Patients enrolled in the Coachella Valley Rescue Mission patients a part of SAC Health\n* Anyone who, in the opinion of the investigators, would be unable to participate in an 8-week trial",{"count":102,"type":22},54,[54],"The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT).\n\nResearchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone.\n\nParticipants:\n\n* will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino\n* or receive both EBT and SOC at ARC\n* in the SOC group will continue monthly visits at ARC and weekly counseling\n* in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone\n* will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC",[106,28,107,108,109,110],"Cannabis Use Disorder","Opioid Use Disorder","Tobacco Use Disorder","Alcohol Use Disorder","Sedative, Hypnotic, or Anxiolytic Use Disorders",[112,113],"early remission","sustained remission","NOT_YET_RECRUITING","2026-04-21",{"date":117,"type":33},"2026-04-23",{"date":119,"type":22},"2026-08",{"date":121,"type":22},"2027-08",{"name":123,"class":40},"Loma Linda University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":41},"100601562","repetitive-transcranial-magnetic-stimulation-treatment-of-stimulant-use-disorder-100601562","NCT07112105","Repetitive Transcranial Magnetic Stimulation Treatment of Stimulant Use Disorder","VA-StARTS","Inclusion Criteria:\n\n* Structured Clinical Interview for DSM Disorders (SCID) confirmed diagnosis of SUD, severe\n* Last use of stimulants \\>2 and \\\u003C8 weeks\n* Stable medication regimen (no change in dose or agents between 2 weeks prior to the start of and throughout the treatment phase of the study)\n* Stable medical health\n\nExclusion Criteria:\n\n* Pregnant or lactating female\n* History of prior adverse reaction to TMS\n* On medications thought to significantly lower seizure threshold, e.g. clozapine, chlorpromazine, clomipramine, and bupropion \\> 400mg\u002Fday\n* Seizure disorder or conditions known to substantially increase risk for seizures\n* Implants or medical devices incompatible with TMS\n* Acute or unstable chronic medical illness that would affect participation or compliance in the study, e.g. unstable angina\n* Unstable psychiatric symptoms that precludes consistent participation in the study, e.g. active current suicidal intent or plan; severe psychosis\n* Other substance use disorder not in remission\n* Chronic or recurring Axis I psychotic disorders\n* For subjects participating in fMRI scans, presence of ferromagnetic material in their body or taking DAergic medications","65 Years",{"count":133,"type":22},106,[54],"The purpose of this study is to establish a new treatment (repetitive transcranial stimulation (rTMS)) for Veterans with stimulant use disorder (SUD). Despite the large public health burden imposed by SUD, there is currently no FDA-approved or widely recognized effective somatic treatment. This placebo controlled study will test the effectiveness of rTMS in the treatment of SUD, and explore biomarkers that may guide patient selection for rTMS treatment and predict treatment response.",[28],[138,139,140,141,142],"Magnetic resonance imaging","Transcranial magnetic stimulation","Intermittent theta burst stimulation","Dopamine","Reward processing","2026-03-27",{"date":145,"type":33},"2026-04-02",{"date":147,"type":22},"2026-05-01",{"date":149,"type":22},"2029-12-31",{"name":151,"class":152},"VA Office of Research and Development","FED",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":174,"locationsCount":41},"100576844","phase-1-optimizing-transcranial-magnetic-stimulation-for-stimulant-use-disorder-100576844","NCT06790576","Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder","Inclusion Criteria:\n\n* Age 18 or older\n* Ability to provide consent and comply with all study procedures.\n* Meets Diagnostic and Statistical Manual of Mental Disorders criteria for StUD (As assessed by MINI and self-report; Participants may have current comorbid drug use, but primary diagnosis must be StUD; does not apply to healthy control participants).\n* At least 2 weeks of abstinence from substance use (other than caffeine or nicotine).\n* Intention to remain in an addiction treatment program until intervention completion (does not apply to healthy control participants).\n* Confident level of English language proficiency.\n\nExclusion Criteria:\n\n* Any organic brain disorder (e.g. TBI, stroke).\n* Head injury resulting in skull fracture or loss of consciousness exceeding 30 minutes.\n* TMS contraindication (history of seizures, metallic cranial plates\u002Fscrews or implanted device).\n* MRI contraindications (unapproved metallic implants, pacemakers or any other implanted electrical device, shrapnel, metallic braces, non-removable body piercings, pregnancy, breathing or movement disorder, claustrophobia).\n* Any psychotic disorder (Participants with other treated and stable psychiatric disorders will be included).\n* Presence of a condition that would render study measures impossible to administer or interpret.\n* Primary current substance use disorder diagnosis on a substance other than stimulants or cocaine, except for caffeine or nicotine.\n* Greater than 9 months abstinence from substance use (does not apply to healthy control participants).\n* Pregnancy or breastfeeding.",{"count":160,"type":22},50,[162],"PHASE1","The study will recruit 50 adults with stimulant use disorder currently in treatment and abstinent for at least 2 weeks. The study will also recruit up to 10 healthy controls (adults without StUD) for initial study configuration. The study will consist of five steps that are expected to be completed over two lab visits.\n\nStep 1: The 3T MRI scan will provide accurate prefrontal cortex anatomy for using neuronavigation for TMS. In addition, the study will use an analysis of resting fMRI connectivity to determine the location in the left DLPFC that has the maximum connectivity with the incentive-salience network.\n\nStep 2: The study will use the data collected at the MRI to select the individual TMS location. EEG will be used to collect TEPs in response to single pulse TMS at the left DLPFC. Participants will then be randomized to one of three conditions: A) TMS unsynchronized with EEG, B) TMS synchronized with EEG theta frequency trough, and C) TMS synchronized with EEG theta frequency peak. The stimulation will be applied with an intensity of up to 120% of the resting motor threshold (which is a safe and common practice; Rossi et al., 2021). The intensity can be decreased for individual participants.\n\nStep 3: Following randomization, the study will administer a pre-iTBS assessment.\n\nStep 4: The study will compare brain and behavioral responses before and after the iTBS session with TMS and EEG synchronization as assigned by their randomized group.\n\nStep 5: The study will administer a post-iTBS assessment.",[28],[166,167],"TMS","MRI","2026-02-05",{"date":170,"type":33},"2026-02-09",{"date":172,"type":33},"2024-12-01",{"date":37,"type":22},{"name":175,"class":40},"University of Minnesota",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100555520","continuum-of-care-in-hospitalized-patients-with-opioidstimulant-use-disorder-and-infectious-complications-from-drug-use-100555520","NCT06513156","Continuum of Care in Hospitalized Patients With Opioid\u002FStimulant Use Disorder and Infectious Complications From Drug Use","Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use\u002FID Integrated Clinic vs. TAU to Prevent Infection Related Readmission","CHOICE-STAR","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)\n3. Injection opioid or stimulant use in past 90 days - per patient self-report\n4. Active suspected or confirmed qualifying infection (see list) at time of admission.\n\nQualifying infections:\n\n* Non-vertebral osteomyelitis\n* Vertebral osteomyelitis or discitis\n* Epidural, subdural, or extradural abscess\n* Intracranial or intraspinal abscess\n* Native joint septic arthritis\n* Prosthetic joint septic arthritis\n* Blood stream infection (bacterial or fungal)\n* Native valve Endocarditis\n* Prosthetic valve endocarditis\n* Cardiac Implantable electronic device infection\n* Infectious pseudoaneurysm and aneurysm\n* Infected vascular graft\n* Septic venous thrombosis\n* Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)\n* Infected skin ulcer\n* Orthopedic hardware infection\n* Muscle abscess\u002Fmyositis\n* Central nervous system infection (bacterial or fungal)\n* Bacterial or fungal ophthalmologic infection\n* Other abscess\n* Pulmonary septic emboli\n* Other acute bacterial or fungal infection deemed appropriate by site study team\n\nExclusion Criteria:\n\n* 1\\. Infection due to a cause other than injection drug use, per determination of a site PI.\n\n  2\\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.\n\n  3\\. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator",{"count":185,"type":22},304,[54],"This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases\u002FSubstance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.",[107,189,28],"Injection Related Infections",[191,192,193,28],"Delivery of Health Care, Integrated","Opioid use disorder","Serious Injection Related Infections","2025-10-29",{"date":196,"type":33},"2025-10-31",{"date":198,"type":33},"2024-10-01",{"date":200,"type":22},"2027-07-30",{"name":202,"class":40},"Elana Rosenthal",4,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":131,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":41},"100550221","phase-2-orexin-receptor-antagonism-and-sleep-in-stimulant-use-disorder-100550221","NCT06444256","Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder","Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study","Inclusion Criteria:\n\n* Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)\n* Be fluent in English and able to understand the consent form\n\nExclusion Criteria:\n\n* Have an opioid use disorder of any severity\n* Have a greater than moderate substance use disorder on any other substance\n* Undergoing medication-assisted treatment for withdrawal of any substance\n* Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)\n* Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)\n* Are pregnant or breast feeding\n* BMI \\> 30 (women only)\n* Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe\n* Have history of seizure disorder\n* Have a head injury with loss of consciousness in the last 5 years",{"count":212,"type":22},20,[25],"The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.",[28],[217,218,219,220],"Psychostimulants","substance use","methamphetamine","cocaine","2025-09-03",{"date":223,"type":33},"2025-09-05",{"date":225,"type":33},"2024-07-25",{"date":227,"type":22},"2027-01-30",{"name":229,"class":40},"The University of Texas Health Science Center, Houston",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":41},"100600020","smartphone-services-for-stimulant-use-disorder-100600020","NCT07092059","Smartphone Services for Stimulant Use Disorder","Decentralized Clinical Trial of Contingency Management Digital Therapeutic to Treat Stimulant Use Disorder","Inclusion Criteria:\n\n* Adults who are at least 18 years old, speak\u002Fread English, have a smartphone, and who meet criteria for Stimulant Use Disorder, active or early remission. If being discharged to outpatient or intensive outpatient care, the patient is eligible.\n\nExclusion Criteria:\n\n* Unwilling to authorize communication with any treatment provider(s), requiring acute detoxification from alcohol or opioids or residential or hospital treatment, or other obstacle to longitudinal participation in the study.\n* Currently pregnant",{"count":238,"type":22},270,[54],"This study is testing two approaches to treating Stimulant Use Disorder, or problems with cocaine, crack, methamphetamine, etc. Stimulant Use Disorder is a national epidemic in the U.S. but there is no FDA-approved medication to treat it. There is a behavioral approach that has been found to be the most effective treatment for Stimulant Use Disorder, but this study is testing whether this can be delivered by a smartphone service, remotely, such as at home.",[28],[243,244,245,220,246,219,247,248,249,250],"cocaine addiction","crack addiction","methamphetamine addiction","crack","stimulants","drug problem","drug addiction","drug abuse","2025-07-25",{"date":253,"type":33},"2025-07-29",{"date":255,"type":33},"2025-06-24",{"date":121,"type":22},{"name":258,"class":259},"DynamiCare Health","INDUSTRY",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":18,"minAge":268,"maxAge":131,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100567270","phase-2-pex010-assisted-therapy-for-stimulant-use-disorder-a-safety-feasibility-and-efficacy-study-100567270","NCT06666010","PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study","A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study","PATSUD","Inclusion Criteria:\n\n* Are between 19 and 65 years old.\n* Have signed the informed consent form for the study\n* Have moderate to severe amphetamine stimulant use disorder (ASUD) as determined by the Mini-International Neuropsychiatric Interview (MINI 7.0.1), and clinical review by the study physician. The focus will be on illicit methamphetamine use.\n* Are treatment-seeking but not currently receiving other treatments for SUD.\n* Have stable housing.\n* Have a local support person (close friend or family member) that is available to accompany them home from the study drug session.\n* Are of non-childbearing potential and\u002For using adequate contraception methods as defined by Health Canada.\n* Non-childbearing potential is defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgical sterilization\n* Have a negative pregnancy test at screening and prior to the study drug session. Must agree to use adequate contraception through 10 days after the study drug session. Adequate contraception methods include intrauterine devices, oral hormones plus barrier contraception, abstinence, injectable or implanted hormonal methods, or vasectomized\u002Fnon-sperm carrying sole partner. Barrier methods alone are not considered effective methods of contraception.\n* Be willing to refrain from caffeine for ≥12 hours, cannabis and stimulants for ≥24 hours, and all other drugs for ≥5 days prior to PEX010 administration such that there are no clinical signs of intoxication or withdrawal.\n* Able and willing to follow study procedure.\n* Able to understand and communicate in English.\n* Complete the Columbia Suicide Severity Rating Scale (CSSRS)\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are within normal limits.\n\nExclusion Criteria:\n\n* Are experiencing or at risk for significant withdrawal.\n* Have any medical condition that would be contraindicated, including previously diagnosed conditions:\n* seizure disorder or history of seizures;\n* a history of significantly impaired hepatic function;\n* a history of unstable or uncontrolled cardiovascular disease (coronary artery disease, heart failure, clinically significant ECG abnormality);\n* uncontrolled hypertension, resting blood pressure \\> 140\u002F90 mmHg; baseline prolongation of QTc interval: \\>450 ms in both males and females;\n* a history of major central nervous system disease (history of cerebrovascular accident, masses, aneurysm);\n* a history of uncontrolled obstructive airway disease or significant respiratory compromise;\n* a history of uncontrolled thyroid disease;\n* a history of uncontrolled insulin dependent diabetes that may preclude safe participation in the study;\n* a history of narrow-angle glaucoma;\n* gastrointestinal conditions which may affect psilocybin absorption (i.e. stenosing peptic ulcer, pyloroduodenal obstruction);\n* a history of active obstructive urological conditions (i.e. symptomatic prostatic hypertrophy, bladder-neck obstruction) that may preclude safe participation in the study.\n* Have a personality disorder deemed to be high risk (antisocial, borderline, narcissistic) assessed via the SCID-5-PD.\n* Have a personal history or family history of either mania\u002Fhypomania or psychosis, including substance-induced psychosis.\n* Have any history of Hallucinogen Perception Disorder\n* Have a history of suicide attempt within the last 6 years or a suicidal ideation in the last year.\n* Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics)\n* Are pregnant, breastfeeding, or not using adequate contraceptives if of childbearing potential.\n* Any other finding(s) based on the screening process that the investigator determines makes the candidate unsuitable for the study\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are not within normal limits\n* Have baseline heart rate outside of normal limits (e.g., \\>100 beats per minute).\n* Subjects currently on medications with serotonergic activity, or taking inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.","19 Years",{"count":270,"type":22},86,[25],"The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are:\n\nDoes PEX010 reduce stimulant use?\n\nWhat medical problems do participants experience when taking PEX010?\n\nResearchers will compare an active PEX010 dose containing 25 mg psilocybin to an active placebo arm, to see if PEX010 works to reduce stimulant use.\n\nParticipants will:\n\nTake PEX010 or the active placebo once during the study, engage in cognitive behavioural therapy, and visit the clinic twice weekly for study intervention and follow-up assessments.",[28],"2024-10-29",{"date":276,"type":33},"2024-10-30",{"date":278,"type":22},"2025-01",{"date":280,"type":22},"2028-07",{"name":282,"class":259},"Filament Health Corp."]