Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 1:58 AM
Study NCT ID:
NCT07434895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated CBD Administration and Cannabis Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline-Subject-Related Outcome-VAS Drug Liking', 'timeFrame': 'Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).', 'description': 'Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.'}, {'measure': 'Change from Baseline-Marijuana Purchase Task: Elasticity', 'timeFrame': 'Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.', 'description': 'Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline-Cold Pressor Test (CPT) Threshold', 'timeFrame': 'Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).', 'description': 'Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominanat hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency (in seconds) to first pain sensations (threshold) will be measured and recorded.'}, {'measure': 'Change from Baseline-Cold Pressor Test (CPT) Tolerance', 'timeFrame': 'Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).', 'description': 'Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency to withdrawal from the water (tolerance) will be measured and recorded.'}, {'measure': 'Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful', 'timeFrame': 'Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.', 'description': 'Participants first immerse a dominant hand in the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Participants will report how painful the pain was on a visual analog scale. Low scores mean little to no pain. Higher scores mean greater pain. Raw data transformed to peak scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['marijuana', 'cannabidiol (CBD)', 'marijuana users'], 'conditions': ['Cannabis', 'Abuse Liability', 'Experimental Pain in Healthy Human Participants']}, 'descriptionModule': {'briefSummary': 'This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking, literate adults,\n* Male or female,\n* Between the ages of 18-55,\n* Body Mass Index from 18.5-32.0 kg/m2,\n* Not currently seeking treatment for cannabis or drug use,\n* Able to provide written informed consent and perform all study procedures,\n* If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),\n* Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and\n* Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.\n\nExclusion Criteria:\n\n* Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,\n* Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \\[e.g., asthma, COPD\\]),\n* Current or past history of major psychiatric disorder that would limit ability to participate in the study,\n* Use of cannabis exclusively for medical reasons (no recreational use reported),\n* Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),\n* Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers,\n* Clinically significant abnormal ECG (as determined by study physician/cardiologist),\n* Clinically significant abnormal laboratory findings,\n* History of seizure disorder,\n* Clinically significant history of head injuries requiring medical management or long lasting sequalae, and\n* Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).'}, 'identificationModule': {'nctId': 'NCT07434895', 'briefTitle': 'Repeated CBD Administration and Cannabis Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study', 'orgStudyIdInfo': {'id': '107878'}, 'secondaryIdInfos': [{'id': 'K01DA056692', 'link': 'https://reporter.nih.gov/quickSearch/K01DA056692', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo CBD/Placebo Inhaled Cannabis', 'description': 'Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day.\n\nInactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally.\n\nInactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.', 'interventionNames': ['Drug: Placebo Cannabidiol', 'Drug: Placebo Inhaled Cannabis']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo CBD/Active Inhaled Cannabis', 'description': 'Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day.\n\nInactive/Placebo Cannabidiol: Active cannabidiol will be administered orally.\n\nActive Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.', 'interventionNames': ['Drug: Active Inhaled Cannabis', 'Drug: Placebo Cannabidiol']}, {'type': 'EXPERIMENTAL', 'label': 'CBD (Medium Dose)/Placebo Inhaled Cannabis', 'description': 'Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.\n\nActive Cannabidiol: Active cannabidiol will be administered orally.\n\nInactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.', 'interventionNames': ['Drug: Cannabidiol, Medium Dose', 'Drug: Placebo Inhaled Cannabis']}, {'type': 'EXPERIMENTAL', 'label': 'CBD (Medium Dose)/Active Inhaled Cannabis', 'description': 'Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.\n\nVaporized Marijuana: Active Marijuana administered through a vaporizer\n\nCannabidiol: Active cannabidiol will be administered orally', 'interventionNames': ['Drug: Cannabidiol, Medium Dose', 'Drug: Active Inhaled Cannabis']}, {'type': 'EXPERIMENTAL', 'label': 'CBD (Higher Dose)/Placebo Inhaled Cannabis', 'description': 'Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.\n\nActive Cannabidiol: Active cannabidiol will be administered orally.\n\nInactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.', 'interventionNames': ['Drug: Cannabidiol, Higher Dose', 'Drug: Placebo Inhaled Cannabis']}, {'type': 'EXPERIMENTAL', 'label': 'CBD (Higher Dose)/Active Inhaled Cannabis', 'description': 'Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.\n\nActive Cannabidiol: Active cannabidiol will be administered orally.\n\nActive Marijuana: Active Marijuana will be administered through a vaporizer.', 'interventionNames': ['Drug: Cannabidiol, Higher Dose', 'Drug: Active Inhaled Cannabis']}], 'interventions': [{'name': 'Cannabidiol, Medium Dose', 'type': 'DRUG', 'description': 'Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.', 'armGroupLabels': ['CBD (Medium Dose)/Active Inhaled Cannabis', 'CBD (Medium Dose)/Placebo Inhaled Cannabis']}, {'name': 'Cannabidiol, Higher Dose', 'type': 'DRUG', 'description': 'Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.', 'armGroupLabels': ['CBD (Higher Dose)/Active Inhaled Cannabis', 'CBD (Higher Dose)/Placebo Inhaled Cannabis']}, {'name': 'Active Inhaled Cannabis', 'type': 'DRUG', 'description': 'Active Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total).', 'armGroupLabels': ['CBD (Higher Dose)/Active Inhaled Cannabis', 'CBD (Medium Dose)/Active Inhaled Cannabis', 'Placebo CBD/Active Inhaled Cannabis']}, {'name': 'Placebo Cannabidiol', 'type': 'DRUG', 'description': 'Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.', 'armGroupLabels': ['Placebo CBD/Active Inhaled Cannabis', 'Placebo CBD/Placebo Inhaled Cannabis']}, {'name': 'Placebo Inhaled Cannabis', 'type': 'DRUG', 'description': 'Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total).', 'armGroupLabels': ['CBD (Higher Dose)/Placebo Inhaled Cannabis', 'CBD (Medium Dose)/Placebo Inhaled Cannabis', 'Placebo CBD/Placebo Inhaled Cannabis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'contacts': [{'name': 'Paul A Nuzzo, M.A.', 'role': 'CONTACT', 'email': 'pnuzz2@email.uky.edu', 'phone': '859-323-0002'}, {'name': 'Hannah M Harris, Ph.D.', 'role': 'CONTACT', 'email': 'hannah.harris@uky.edu'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Paul A Nuzzo, M.A.', 'role': 'CONTACT', 'email': 'pnuzz2@email.uky.edu', 'phone': '859-323-0002'}], 'overallOfficials': [{'name': 'Hannah M Harris, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannah Harris', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hannah Harris', 'investigatorAffiliation': 'University of Kentucky'}}}}