[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658093":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":47,"studyPopulation":33,"armGroups":48,"interventions":77,"overallOfficials":33,"centralContacts":83,"locations":89,"responsibleParty":103,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":33,"studyType":125,"phases":126,"briefSummary":129,"conditions":130,"keywords":33,"overallStatus":132,"whyStopped":33,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":33},[9,13,17,21,24,27,30],{"measure":10,"description":11,"timeFrame":12},"Peak change from baseline Drug Effect","Peak self-reported \"Drug Effect\" on a visual analogue scale (0-100) minus baseline ratings of self-reported \"Drug Effect\" on a visual anaogue scale (0-100)","8 hour study sessions",{"measure":14,"description":15,"timeFrame":16},"Peak change from baseline Good Effect","Peak self-reported \"Good Effect\" on a visual analogue scale (0-100) minus baseline ratings of self-reported \"Good Effect\" on a visual anaogue scale (0-100), where lower scores indicate no effect and greater scores indicate maximum effect.","Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration",{"measure":18,"description":19,"timeFrame":20},"Peak Cold Pressor Test Tolerance change from baseline score","Peak Cold Pressor Test Tolerance Score minus baseline Peak Cold Pressor Test Tolerance score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.","Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration",{"measure":22,"description":23,"timeFrame":20},"Peak Cold Pressor Test Threshold change from baseline score","Peak Cold Pressor Test Threshold Score minus baseline Peak Cold Pressor Test Threshold score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.",{"measure":25,"description":26,"timeFrame":20},"Peak Heat Pain with Capsaicin Threshold change from baseline score","Peak Heat Pain with Capsaicin Threshold score minus baseline Peak Heat Pain with Capsaicin Threshold score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.",{"measure":28,"description":29,"timeFrame":20},"Peak Heat Pain with Capsaicin Tolerance Change from Baseline Score","Peak Heat Pain with Capsaicin Tolerance score minus baseline Peak Heat Pain with Capsaicin Tolerance score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.",{"measure":31,"description":32,"timeFrame":16},"Peak change from baseline Bad Effect","Peak self-reported \"Bad Effect\" on a visual analogue scale (0-100) minus baseline ratings of self-reported \"Bad Effect\" on a visual anaogue scale (0-100) where lower scores indicate no effect and greater scores indicate maximum effect.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","CROSSOVER","Within-subject test of blinded study medications","TREATMENT",{"masking":40,"maskingDescription":41,"whoMasked":42},"QUADRUPLE","Drug class is blinded to participant.",[43,44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a human laboratory systematic examination of whether adding the FDA-approved gabapentin (Neurontin; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) will change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with chronic lower back pain and no history of substance use disorder. Study subjects and staff are blinded to the study drugs and the class of drugs under investigation and are informed that subjects may receive opioids, stimulants, gabapentinoids, cannabinoids, benzodiazepines, over the counter medications, and\u002For placebo. Sessions last up to 8-hours in an outpatient setting. Primary outcomes are collected from participants prior to dosing and at several hour periods post-dosing.",[49,55,60,64,69,73],{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo hydromorphone, Placebo gabapentin","PLACEBO_COMPARATOR","0mg oral hydromorphone, 0mg oral gabapentin",[54],"Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)",{"label":56,"type":57,"description":58,"interventionNames":59},"Active hydromorphone, Low dose gabapentin","EXPERIMENTAL","4mg oral hydromorphone, 300mg oral gabapentin",[54],{"label":61,"type":57,"description":62,"interventionNames":63},"Active hydromorphone, High dose gabapentin","4mg oral hydromorphone, 900mg oral gabapentin",[54],{"label":65,"type":66,"description":67,"interventionNames":68},"Placebo hydromorphone, Low dose gabapentin","ACTIVE_COMPARATOR","0mg oral hydromorphone, 300mg oral gabapentin",[54],{"label":70,"type":66,"description":71,"interventionNames":72},"Placebo hydromorphone, High dose gabapentin","0mg oral hydromorphone, 900mg oral gabapentin",[54],{"label":74,"type":66,"description":75,"interventionNames":76},"Active hydromorphone, placebo gabapentin","4mg oral hydromorphone, 0mg gabapentin",[54],[78],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":33},"DRUG","Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)","Within-subject double-blind, double-dummy, study design wherein all participants received all drug combinations (Placebo + Placebo, Hydromorphone + Placebo, Low Dose Gabapentin + Placebo, High Dose Gabapentin + Placebo, Low Dose Gabapentin + Hydromorphone, High Dose Gabapentin + Hydromorphone) in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.",[61,56,74,70,65,50],[84],{"name":85,"role":86,"phone":87,"phoneExt":33,"email":88},"Sarah Dowell","CONTACT","667-351-5088","sdowell@som.umaryland.edu",[90],{"facility":91,"status":33,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":33},"Kahlert Institute for Addiction Medicine","Baltimore","Maryland","21201","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-76.61219,39.29038,{"lat":101,"lon":100},{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Cecilia Bergeria","Associate Professor",[108],{"name":109,"class":110},"National Institute on Drug Abuse (NIDA)","NIH","100658093","phase-1-mechanistic-evaluation-of-polypharmacy-effects-for-pain-100658093",false,"NCT07846020","Mechanistic Evaluation of Polypharmacy Effects for Pain","Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy","PAT","Inclusion Criteria:\n\n* 18-65 years old\n* Lifetime history of opioid use\n* Medically cleared to take study medications\n* Chronic Lower Back Pain\n* Agree to use effective form of contraception throughout enrollment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Have evidence of physical dependence on or current use of any central nervous system depressants including but not limited to alcohol, benzodiazepines, opioids, gabapentinoids, or barbiturates\n* Past 30-day use of certain pain medications\n* Evidence of past 7-day nonmedical drug use\n* Known hypersensitvity, allergy to, or history of adverse reactions to study medications\n* Are currently taking a medication or have a condition that is contraindicated with either study medication\n* Have evidence of current or past significant medical\u002Fpsychiatric illness\n* Have a history of clinically significant cardiac arrhythmias or vasospastic disease\n* Have evidence of renal or hepatic impairment\n* Current suicidal ideation or behavior, or a history of a suicide attempt within the past 2 years\n* Have any condition that may increases the risk for respiratory depression","ALL","18 Years","65 Years",{"count":123,"type":124},110,"ESTIMATED","INTERVENTIONAL",[127,128],"PHASE1","PHASE2","This is a single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined.",[131],"Chronic Lower Back Pain (CLBP)","NOT_YET_RECRUITING","2026-09-22",{"date":135,"type":136},"2026-09-29","ACTUAL",{"date":138,"type":124},"2027-01-15",{"date":140,"type":124},"2032-04-01",{"name":5,"class":6},1]