Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 5:35 AM
Study NCT ID:
NCT06218550
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}, {'id': 'C035731', 'term': 'delta-8-tetrahydrocannabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo controlled, double blind drug administration'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A within-subjects design. At the time of study randomization, participants will be assigned to complete Sub-Study 1 followed by Sub-Study 2, or vice versa, using a counter-balanced randomization sequence. The order in which dose conditions are administered within each sub-study will be randomized across participants because there are too many drug conditions to fully counterbalance dosing within sub-studies at the proposed sample size.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Deviation of Lateral Position (SDLP) in cm', 'timeFrame': '0-8 hours', 'description': 'A measure of lane weaving during simulated driving performance, the standard deviation of lateral position is a standard metric of impairment in driving performance. A score of 0 (perfect score, no deviation) is the minimum score possible and there is no upper threshold score. Higher scores equate to worse performance (more lane weaving).'}], 'secondaryOutcomes': [{'measure': 'Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)', 'timeFrame': '0-8 hours', 'description': 'Peak rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No drug effect and 100 being maximum drug effect'}, {'measure': 'Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App', 'timeFrame': '0-8 hours', 'description': 'Peak Global Impairment score (0-75) recorded as a result of performance on the DRUID App, a brief cognitive task battery completed on a mobile device (e.g., iPad). Larger scores indicate worse performance on the task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis']}, 'descriptionModule': {'briefSummary': 'Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.', 'detailedDescription': 'The present study will characterize the acute effects of oral and inhaled ∆8-THC, compared with a positive control dose of ∆9-THC and placebo, on subjective drug effects, cardiovascular effects, cognitive performance, simulated driving performance, field sobriety tests, and drug testing outcomes in oral fluid, blood, hair, and urine. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The result will be a comparative pharmacology and toxicology dataset for ∆8-THC and ∆9-THC via both oral ingestion and inhalation, two routes of administration that are predominant in retail products currently being sold across the U.S. This study will provide urgently needed data on the behavioral pharmacology and toxicology of ∆8-THC, a novel cannabinoid that is now widely available, but for which there is little public knowledge or public health messaging. This data will directly inform the impact of ∆8-THC use on drug testing programs, and the comparative effects of ∆8-THC to ∆9-THC can be used to inform regulatory decisions related to public safety and the sale of these products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be between the ages of 18 and 55\n2. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n3. Test negative for recent cannabis use prior to each experimental test session\n4. Test negative for drugs of abuse and alcohol prior to each experimental test session\n5. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission\n6. Have a body mass index (BMI) in the range of 19 to 36 kg/m2\n7. Report use of cannabis in the past 3 years (both sub-studies) and prior experience inhaling cannabis (either via smoking or vaporization) for vaporization sub-study participation\n8. Have not donated blood in the prior 30 days.\n9. Have a current government-issued driver's license\n\nExclusion Criteria:\n\n1. Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.\n2. History of or current evidence of health issues judged by the investigator to put the participant at greater risk of experiencing an adverse event due to drug exposure or completion of other study procedures.\n3. Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).\n4. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.\n5. Participation in other research projects that could impact the present study"}, 'identificationModule': {'nctId': 'NCT06218550', 'briefTitle': 'Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment', 'orgStudyIdInfo': {'id': 'IRB00394164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo', 'description': 'A brownie containing no experimental drugs will be eaten by study participants', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Oral administration of 30mg ∆8-THC', 'description': 'A brownie infused with 30mg ∆8-THC will be eaten by study participants', 'interventionNames': ['Drug: Delta-8-THC']}, {'type': 'EXPERIMENTAL', 'label': 'Oral administration of 60mg ∆8-THC', 'description': 'A brownie infused with 60mg ∆8-THC will be eaten by study participants', 'interventionNames': ['Drug: Delta-8-THC']}, {'type': 'EXPERIMENTAL', 'label': 'Oral administration of 30mg ∆9-THC', 'description': 'A brownie infused with 30mg ∆9-THC will be eaten by study participants', 'interventionNames': ['Drug: Delta-9-THC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Administration of vaporized Placebo', 'description': 'Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Administration of vaporized 30mg ∆8-THC', 'description': 'Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")', 'interventionNames': ['Drug: Delta-8-THC']}, {'type': 'EXPERIMENTAL', 'label': 'Administration of vaporized 60mg ∆8-THC', 'description': 'Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")', 'interventionNames': ['Drug: Delta-8-THC']}, {'type': 'EXPERIMENTAL', 'label': 'Administration of vaporized 30mg ∆9-THC', 'description': 'Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")', 'interventionNames': ['Drug: Delta-9-THC']}], 'interventions': [{'name': 'Delta-9-THC', 'type': 'DRUG', 'description': 'Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers', 'armGroupLabels': ['Administration of vaporized 30mg ∆9-THC', 'Oral administration of 30mg ∆9-THC']}, {'name': 'Delta-8-THC', 'type': 'DRUG', 'description': 'Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers', 'armGroupLabels': ['Administration of vaporized 30mg ∆8-THC', 'Administration of vaporized 60mg ∆8-THC', 'Oral administration of 30mg ∆8-THC', 'Oral administration of 60mg ∆8-THC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers', 'armGroupLabels': ['Administration of vaporized Placebo', 'Oral Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Behavioral Pharmacology Research Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ryan Vandrey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Substance Abuse and Mental Health Services Administration (SAMHSA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}