[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-related-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-related-disorders":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,81,110,137,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100342953","outcome-inference-in-the-sensory-preconditioning-task-in-opioid-use-disorder-100342953",false,"NCT03745339","Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder","Outcome Inference in the Sensory Preconditioning Task in Opioid-use Disorder","* INCLUSION CRITERIA:\n\nThe enrollment target for the protocol is 120 (40 healthy controls, 40 patients on agonist maintenance, and 40 participants who have met DSM 5 criteria for OUD, but are now abstinent (for at least 3 weeks) and not on agonist maintenance.\n\nAll Participants\n\n* Age between 21 and 65 years inclusive. Rationale: objective olfactory impairment grows more prevalent with age; after age 53, the prevalence is 24.5%, increasing to 62.5 % in people aged 80-97 years.\n* Willing to fast for at least 6 hours prior to the study session and be exposed to food odors. These will be assessed with the \"019 Additional History Form\" questionnaire.\n\nAdditional Criteria for Abstinent OUD group\n\n* History of opioid-use disorder (DSM-5), to be assessed via the Mini International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM-5 (SCID). History of SUDs can include substances in addition to opioids (e.g., cocaine).\n* Abstinent \\> 3 weeks from all illicit substances (tobacco smoking and nondependent drinking permissible), to be assessed via 30-day timeline follow-back calendar. (Current abstinence will be confirmed via urine screen: see exclusion criteria.) Rationale: Although heterogeneity will be considerable, what all enrollees will have in common is having become abstinent from opioids long enough to be past withdrawal symptoms. Their heterogeneity in duration of abstinence and other drug-history measures will enable us to examine relationships between those things and inferencing performance.\n\nAdditional Criteria for In-treatment OUD group\n\n-Current enrollment in treatment for OUD with buprenorphine or methadone (\\>3 weeks on stable dose). Current use of illicit substances during treatment is permissible but not required. Rationale: Again, heterogeneity will be considerable, but what all enrollees will have in common is having sought treatment for their OUD and being currently maintained on an agonist that permits adaptive everyday functioning. Their heterogeneity in ongoing use of illicit substances will enable us to examine relationships between inferencing performance and treatment response.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via Sniffin Sticks threshold test \\\u003C4 or via Sniffin Sticks odor identification test \\\u003C10.\n* History of any neurological condition resulting in inability to perform study task. Examples include but not limited to degenerative processes of the CNS (Parkinson disease, Alzheimer disease); other neurologic diseases (Huntington disease, multiple sclerosis, other motor-neuron diseases); inflammatory conditions (sarcoidosis, Wegener granulomatosis); or significant cerebrovascular disease including (but not limited to) epilepsy, stroke, or meningitis; traumatic brain injury (TBI) or major head trauma with sustained loss of consciousness (\\>30 min). To be assessed by history and physical and evaluation to sign screening consent. Eligibility will be determined based on MAI review of participants ability to perform study task. MAI will consider but is not limited to H and P results for mental status exam, language exam, and attention span exam. Rationale: any of these could impair task performance.\n* History of current (past 12 months) uncontrolled DSM-5 major psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, and PTSD. (Candidates will not be excluded for a history of major psychiatric disorder that is now being successfully treated.) To be assessed by MINI or SCID interview. Rationale: could impair task performance.\n* History of anaphylaxis due to, e.g., significant asthma, food or non-food allergy, or intolerance to odors (including latex, detergents, soaps, etc.). To be assessed by history and physical. Rationale: could make odorant exposure risky.\n* Current use of medications or substances that affect alertness and that cannot be withheld on the morning of the study visit (e.g., barbiturates, benzodiazepines, cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.). To be assessed by history and physical. Whether candidate will be requested to withhold any medication will be determined based on MAI judgment. Additionally, if participant has a BrAC \\>0.08, MAI will use clinical judgement to determine if participant should be rescheduled. Rationale: could impair task performance.\n* For women: pregnancy. To be assessed by history and physical and by urine testing. Rationale: Could affect task performance-physiological and hormonal changes during pregnancy influence rhinological function.\n* Any other medical illness or condition that in the judgment of the investigators is incompatible with study participation.\n\nAdditional criteria for Control Group\n\n* History of a substance-use disorder (except nicotine, for matching purposes), or current use of any drug for nonmedical purposes. Controls, who cannot have a history of OUD, will be assessed by their medical history and physical examination for the presence of any signs or symptoms consistent with opioid withdrawal. Any Control with any sign or symptom consistent with opioid withdrawal will be evaluated by the MAI to rule out opioid withdrawal if possible.\n* Urine positive for any illicit drug. Rationale: Controls should have no drug use. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.\n\nAdditional criteria for Abstinent Group\n\n* Urine positive for any illicit drug. Rationale: Abstinent OUD group should have no drug use in the last 3 weeks which would include the several-day time frame to which urine screens are sensitive. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.\n* Current signs or symptoms of opioid withdrawal. These will be assessed in the Abstinent group via the Clinical Opioid Withdrawal Scale (COWS) and the Subjective Opioid Withdrawal Scale (SOWS).\n\nAdditional criteria for In-treatment OUD group\n\n-Urine negative for opioid agonist that the participant is taking as part of their OUD treatment. Rationale: In-treatment OUD group should be in treatment. A negative test suggests the participant is not adhering to their treatment plan. In-treatment OUD participants may test positive for other substances as well as their opioid agonist because they may have ongoing illicit drug use.",true,"ALL","21 Years","60 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","Background:\n\nPeople with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors.\n\nObjective:\n\nTo see if performance in a learning task differs between people who have opioid-use disorder and people who don t.\n\nEligibility:\n\nAdults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment.\n\nDesign:\n\nParticipants will have 1 visit that will take up to 5 hours.\n\nBefore the visit, participants will be asked to not eat or drink anything except water for at least 6 hours.\n\nAt the visit, participants will be checked for signs of intoxication.\n\nParticipants will give urine and breath samples.\n\nParticipants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors.\n\nThe odors will come from a sterile tube placed under the nose.\n\nParticipants will have their breathing monitored with a belt around the upper abdomen.\n\nAbout 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days.",[26,27],"Opioid-Related Disorders","Drug Addiction",[29,30,31,32,33],"Addiction","Orbitofrontal Cortex","Associative Learning","Implicit Learning","Natural History","RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2019-06-07",{"date":42,"type":22},"2026-10-01",{"name":44,"class":45},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100644226","pre-pilot-wings-mhealth-to-improve-moud-uptake-in-women-experiencing-intimate-partner-violence-and-ptsd-100644226","NCT07665502","Pre-Pilot WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD","Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD","Inclusion Criteria:\n\n* Identify as a woman (cis-gender or transgender)\n* Aged 18 or older\n* Report use of non-prescribed opioids in the past 30 days\n* Score positive for risk of opioid use disorder or other substance use disorder on the Drug Abuse Screening Test (DAST) with a cut-off score of 6 or higher\n* Report experiencing any severe psychological abuse or any physical or sexual abuse by a female or male intimate partner in the past year\n\nExclusion Criteria:\n\n* Evidence of significant psychiatric or cognitive impairment that would limit effective participation, as confirmed during informed consent\n* Inability to speak and understand English sufficiently to participate in assessments or intervention sessions","FEMALE","18 Years",{"count":57,"type":22},7,"INTERVENTIONAL",[60],"NA","The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women. .\n\nThe main questions it aims to answer are:\n\n1. Does WINGS+++ lower non-prescription opioid and other drug use in women?\n2. Does WINGS+++ help connect women to treatment for substance use, intimate partner violence, and post-traumatic stress disorder (PTSD)?\n\nResearchers will compare WINGS+++ to standard care to see if WINGS+++ works better to lower drug use and link women to helpful services.\n\nWINGS+++ is a 3-session program on a mobile device that:\n\n* Screens for intimate partner violence, PTSD, and substance use\n* Offers brief support and referrals based on each woman's needs and preferences\n* Connects women to a peer navigator who helps link them to services\n\nParticipants will:\n\n* Take part in only the WINGS+++ program for the pre-pilot\n* Answer survey questions about drug use, intimate partner violence, and PTSD symptoms\n* Provide biological samples (such as urine or hair) to check for drug use\n* Share information about the services they have used",[26,63,64,65,66,67,68],"Substance-Related Disorders","Intimate Partner Violence (IPV)","Stress Disorders, Post-Traumatic","Domestic Violence","Medication for Opioid Use Disorder (MOUD)","Post Traumatic Stress Disorder PTSD","NOT_YET_RECRUITING","2026-06-18",{"date":72,"type":38},"2026-06-24",{"date":74,"type":22},"2026-06-15",{"date":76,"type":22},"2027-08-31",{"name":78,"class":79},"Dawn A. Goddard-Eckrich","OTHER",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100545851","phase-3-optimizing-chronic-pain-care-with-mindfulness-and-chronic-pain-management-visits-100545851","NCT06387290","Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits","Inclusion Criteria:\n\n* Age 18 +\n* Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment\n* Prescribed long-term opioid therapy (≥3 months)\n* Score \\>=3 on the Pain Enjoyment General Activity scale\n* Score \\>=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR patient or physician determination that risks of opioid use may outweigh the benefits of opioid use\n\nExclusion Criteria:\n\n* Chronic pain due to a cancer diagnosis\n* Active suicidal intent, schizophrenia, psychotic disorder\n* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement",{"count":88,"type":22},300,[90],"PHASE3","The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.",[93,94,63,95,96,97,98,26,99],"Chronic Pain","Prescription Opioid Misuse","Pain","Narcotic-Related Disorders","Chemically-Induced Disorders","Mental Disorders","Neurologic Manifestations","2026-01-30",{"date":102,"type":38},"2026-02-03",{"date":104,"type":38},"2025-02-25",{"date":106,"type":22},"2028-05-01",{"name":108,"class":79},"University of Utah",3,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":58,"phases":119,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":46},"100516225","phase-2-psilocybin-in-cancer-pain-study-100516225","NCT06001749","Psilocybin in Cancer Pain Study","Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Participants must be 18 year old or older;\n* Participants must have advanced cancer, defined as a cancer that is unlikely to be cured or controlled with treatment;\n* Participants must have progressed on or be intolerant to approved therapies with a known clinical benefit (unless it is documented that they have refused such treatments);\n* Participants must evaluate their average pain on BPI Severity Scale ≥ 4\u002F10 over the past week;\n* Participants must receive chronic opioid pharmacotherapy for pain with an Oral Morphine Equivalent (OME) ≥ 200mg\u002Fday;\n* Participants must have been seen by a palliative care clinician either at DFCI, MGH or associated satellites in the last three months;\n* Participants must have an ECOG Performance Status ≤ 2\n* Participants must meet the following organ and marrow function on their last available bloodwork as defined below:\n\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* Participants must be able to understand and willing to sign a written informed consent document\n* Participants must be able to swallow pills.\n* Participants must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n* Participants must agree to inform the investigators within 48 hours of any new medical conditions and procedures.\n* Participants must agree to the following lifestyle modifications (described in more detail in Section 3.4 Lifestyle Modifications):\n\n  * Comply with requirements for diet,\n  * Refrain from certain medications prior to Experimental Sessions,\n  * Be driven home after each Experimental Session,\n  * Commit to medication dosing, therapy, and study procedures.\n\nExclusion Criteria:\n\n* Participants who receive concurrent (less than four weeks or planned within 6 weeks) cytotoxic chemotherapy or radiation therapy that may impair general level of physical functioning or affect study outcomes;\n* Participants with a condition impairing oral intake or digestive absorption;\n* Participants who are not able to give adequate informed consent;\n* Participants who have a significant suicide risk as defined by suicidal ideation with intent and with or without a plan as endorsed on items 4 and\u002For 5 on the C-SSRS within the past 6 months or at V0\n* Participants who have a history of, or a current diagnostic of primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder; and participants who have an ongoing substance use disorder (defined as active in the past year). Participants with first-degree relatives with schizophrenia or bipolar disorder may be eligible depending on their age and personal and family psychiatric history. The decision will be made by the principal investigator and study psychiatrist based on risk assessment.\n* Participants for whom there is a potential for adverse drug-drug interactions. Concomitant medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. These include the following:\n\n  * Serotoninergic antidepressants\n  * Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)\n  * Tricyclic Antidepressants (TCAs)\n  * Efavirenz\n  * serotonin-acting dietary supplements (i.e. 5-hydroxy-tryptophan or St. John's wort)\n  * Centrally-acting serotonergic agents (e.g. MAO inhibitors)\n  * Antipsychotics (e.g. first and second generation)\n  * Mood stabilizers (e.g. lithium, valproic acid)\n  * Aldehyde dehydrogenase inhibitors (e.g. disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10 Any psychiatric medication will be tapered if possible in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the psilocybin Session to avoid the possibility of any drug-drug interaction (the interval will be at least five times the particular drug and active metabolites' half-life + one week for stabilization). See section 5.3 of the protocol for concomitant medications and tapering instructions.\n* Participants who have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).\n* Participants with brain tumors or brain metastases that haven't been successfully treated\n* Participants with lab abnormalities that may contribute to somnolence, confusion or delayed metabolism of psilocybin and\u002For with severe lab abnormalities (grade 3 or more per CTCAE scale).\n* Participants with a diagnosis of cirrhosis or liver failure\n* Participants who have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher assessed on three separate occasions)\n* Participants who have a heart rate \\> 100 bpm on three separate occasions\n* Participants who have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n* Participants who have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n* Participants who have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled if they have been successfully treated.\n* Participants who have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Participants who have a history of myocardial infarction, coronary artery disease or heart failure\n* Participants who have a marked Baseline prolongation of QT\u002FQTc interval. For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected on the triplicate ECGs performed at screening, using Fridericia's formula \\[QTcF\\] \\> 450 milliseconds \\[ms\\] in males and \\> 460 ms in females.\n* For transgender or non binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.\n* Women who are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control. Acceptable methods of contraception are the following: intrauterine device, injected\u002F implanted\u002F intravaginal\u002F transdermal hormonal method, oral hormones plus a barrier contraception, abstinence, vasectomized sole partner, or double barrier contraception.\n* Participants who have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).",{"count":118,"type":22},15,[120],"PHASE2","The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.\n\nThe name of the study intervention used in this research study is:\n\nPsilocybin (a tryptamine derivative)",[26,123,124,125,126],"Pain Management","Pain Management and Care","Advanced Cancer","Advanced Cancers",[26,123,124,125,126],"2025-12-15",{"date":130,"type":38},"2025-12-16",{"date":132,"type":38},"2024-09-23",{"date":134,"type":22},"2026-12-31",{"name":136,"class":79},"Yvan Beaussant, MD, MSci",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":46},"100566142","fmri-and-opioid-abstinence-100566142","NCT06651333","fMRI and Opioid Abstinence","Functional Connectivity Mechanisms of Opioid Abstinence","Inclusion Criteria:\n\n* recent initiation of methadone or buprenorphine at a clinic or program within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest);\n* eligibility for MRI scanning;\n* ability to commit to study visits.\n\nExclusion Criteria:\n\n* current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;\n* current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;\n* severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore \\\u003C30 (i.e., severe impairment)\n* past or present history of intellectual disability, developmental disorder, or neurological disease;\n* head trauma with loss of consciousness \\>30 min;\n* organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.","50 Years",{"count":146,"type":22},240,"This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.",[149,150,26,151,152],"Drug Use Disorder","Opioid Dependence","Opioid Use","Opioid Abuse",[154],"Relapse","2025-10-16",{"date":157,"type":38},"2025-10-20",{"date":159,"type":38},"2024-12-12",{"date":161,"type":22},"2029-11",{"name":163,"class":79},"Yale University",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":58,"phases":173,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":46},"100551039","developing-a-smartphone-application-to-support-veteran-opioid-use-disorder-treatment-100551039","NCT06454903","Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment","Developing a Smartphone Application to Support the Functional Needs of Veterans in Medication Treatment for Opioid Use Disorder","Inclusion Criteria:\n\nFor the Phase 3, Stage 1b RCT we will be recruiting Veterans enrolled within the VA CT Healthcare System with:\n\n* Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes\n* Active Medication treatment for OUD prescription for buprenorphine or methadone (in any formulation)\n* A working smartphone with wireless capabilities (to allow for download of ACT to RECOVER) or is willing to use a study-provided smartphone\n* Competency to provide written informed consent\n* 18 years of age or older\n\nExclusion Criteria:\n\nParticipants may not:\n\n* Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit\n* Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)\n* Be expressing current, active suicidal\u002Fhomicidal ideation (i.e., current intent to harm themselves or someone else)\n* Have any cognitive\u002Fmedical impairment precluding study participation or use of smartphones\u002Fsmartphone applications.",{"count":172,"type":22},75,[60],"Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD.\n\nAcceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care.\n\nFortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in \"real-world\" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD.\n\nThe proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called \"ACT to RECOVER\" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery).\n\nThe study will occur in 3 phases:\n\nPhase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10).\n\nPhase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability.\n\nPhase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20).\n\n* (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures.\n* (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.",[26,176,177],"Psychosocial Functioning","Quality of Life",[26,176,177,179,180,181,182],"Mobile Applications","Smartphone Apps","Acceptance and Commitment Therapy","User-Centered Design","2025-08-26",{"date":185,"type":38},"2025-08-27",{"date":187,"type":38},"2025-04-02",{"date":189,"type":22},"2029-09-30",{"name":191,"class":192},"VA Office of Research and Development","FED"]