Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-29 @ 1:22 PM
Study NCT ID:
NCT06312657
Status:
TERMINATED
Last Update Posted:
2025-12-05
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-18', 'size': 135855, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-30T19:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Funding ended', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Task choices', 'timeFrame': 'Tasks will take approximately 45-60 minutes to complete. Participants will complete 5 sessions in which a choice task will be administered.', 'description': 'Number of choices of each option selected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.\n* History of intravenous opioid use.\n* Baseline O2 saturation of 95% or greater.\n* Between the ages of 18-50 years.\n* Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.\n* Able to speak and read English.\n* Otherwise healthy.\n\nExclusion Criteria:\n\n* History of, or current, clinically significant physical disease (e.g., respiratory disease \\[asthma, COPD, sleep apnea\\], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.\n* Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.\n* Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).\n* Vision or hearing problems that would preclude completion of experimental tasks.\n* Poor venous access.\n* Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions.\n* At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.\n* Seeking treatment for SUD or currently taking buprenorphine or methadone as the primary opioid of use.'}, 'identificationModule': {'nctId': 'NCT06312657', 'acronym': 'BED(In)(44)', 'briefTitle': 'Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice', 'orgStudyIdInfo': {'id': '81971'}, 'secondaryIdInfos': [{'id': 'R01DA047368', 'link': 'https://reporter.nih.gov/quickSearch/R01DA047368', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Money-vs-money task', 'interventionNames': ['Behavioral: Drug Cue']}, {'type': 'EXPERIMENTAL', 'label': 'Drug-vs-money task', 'interventionNames': ['Behavioral: Money', 'Drug: Withdrawal']}], 'interventions': [{'name': 'Drug Cue', 'type': 'BEHAVIORAL', 'description': 'Individualized drug cues paired with choice options reinforced by $0.25', 'armGroupLabels': ['Money-vs-money task']}, {'name': 'Money', 'type': 'BEHAVIORAL', 'description': 'Two money values will be tested ($0.25 and $4.00)', 'armGroupLabels': ['Drug-vs-money task']}, {'name': 'Withdrawal', 'type': 'DRUG', 'description': 'Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.', 'armGroupLabels': ['Drug-vs-money task']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joshua A. Lile, Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joshua A. Lile, Ph.D.', 'investigatorAffiliation': 'University of Kentucky'}}}}