Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT05007561
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2021-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily feelings of social connection via ecological momentary assessment', 'timeFrame': 'post-treatment, change across 7 days', 'description': 'State feelings of social connection outside of the lab'}, {'measure': 'Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs', 'timeFrame': 'Day 7, approximately 60 mins after taking study drug', 'description': 'In the MRI scanner, participants read sentences written by people they know and people they do not know in a block design. In a second task they view images of people they know, those they do not know, and other emotional images. Brain activity will be measured as BOLD activity in response to stimuli from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity will be masked to activity in structural regions-of- interest (ROIs) of the ventral striatum (VS), middle-insula (MI), anterior cingulate cortex (ACC) and ventromedial prefrontal cortex (VMPFC).'}, {'measure': 'feelings in response to neuroimaging tasks', 'timeFrame': 'Day 7, approximately 150 minutes after taking study drug', 'description': 'Feelings of social connection and general positive affect in response to the neuroimaging tasks will be reported on a scale of 1 (not at all) to 7 (very)'}], 'secondaryOutcomes': [{'measure': 'physical symptoms via daily diary', 'timeFrame': 'end of day on days 1-7', 'description': 'Physical symptoms previously associated with naltrexone will be assessed as well as the subjective experience of the symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Naltrexone', 'Placebo']}, 'descriptionModule': {'briefSummary': 'The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good health\n* English fluency\n* willing to provide contact information for 4-6 close others\n* willing to provide digital photographs of 2 close others\n* own a smartphone\n\nExclusion Criteria:\n\n* presence of medical devices, implants, or other metal objects in or on the body that cannot be removed\n* tattooed eyeliner\n* a body habitus prohibiting MRI scanning\n* claustrophobia\n* self-reported chronic mental or physical illness\n* current and regular use of prescription medication\n* previous history of having difficulty taking pills\n* current use of opioid analgesics\n* depressive symptoms above a 9 on Patient Health Questionnaire\n* excessive alcohol use\n* positive urine drug test\n* body mass index (BMI) greater than 35\n* pregnancy or plans to become pregnant in next 6 months\n* positive urine pregnancy test'}, 'identificationModule': {'nctId': 'NCT05007561', 'briefTitle': 'Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences', 'orgStudyIdInfo': {'id': 'HS-2020-0188-SMT'}, 'secondaryIdInfos': [{'id': 'R01DA052883', 'link': 'https://reporter.nih.gov/quickSearch/R01DA052883', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naltrexone', 'description': '50mg naltrexone HCL once daily for seven days by mouth', 'interventionNames': ['Drug: Naltrexone Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'sugar pill once daily for seven days by mouth', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Naltrexone Hydrochloride', 'type': 'DRUG', 'otherNames': ['oral naltrexone', 'naltrexone pill', 'naltrexone', 'naltrexone oral tablet'], 'description': 'oral naltrexone', 'armGroupLabels': ['Naltrexone']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'oral sugar pill', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tristen Inagaki, PhD', 'role': 'CONTACT'}], 'facility': 'San Diego State University', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Tristen Inagaki, PhD', 'role': 'CONTACT', 'email': 'tinagaki@sdsu.edu', 'phone': '6195941058'}], 'overallOfficials': [{'name': 'Tristen Inagaki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'After publication of the primary findings.', 'ipdSharing': 'YES', 'description': "Data and resources from the current study will be deposited in the Open Science Framework (OSF) and OpenNEURO.org, in accordance with the NIH Data Sharing Policy. In addition, results will be posted on the ClinicalTrials.gov website within 1 year of the study's completion date.", 'accessCriteria': 'Researchers in both private and public sector'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tristen Inagaki', 'investigatorAffiliation': 'San Diego State University'}}}}