Clinical TrialID 8190
PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
NCT05906511
Pain, Tolerance|Oral vs Vaporized THC|Abuse Liability
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8190
- Evidence Id
- 8190
- Core Evidence Id
- 8190
- Source Clinical Trial Id
- 8188
- Herb2 Clinical Trial Id
- HBCT008188
- Nct Id
- NCT05906511
- Title
- PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
- Status
- Recruiting
- Phase
- Early_Phase 1
- Study Result
- No
- Study Condition
- Pain, Tolerance|Oral vs Vaporized THC|Abuse Liability
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
- Intervention
- DRUG: Dronabinol 5 MG|DRUG: Dronabinol 10 MG|DRUG: 2mg Purified THC in an ethanolic solution|DRUG: 4mg Purified THC in an ethanolic solution|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Double
- Intervention Purpose
- Other
- Gender
- All
- Age
- Older_Adult
- Enrollment
- 30
- Outcome Measure
- Peak concentration (Cmax), Serial blood samples will be collected for plasma levels of THC; its phase I metabolite 11-hydroxy-THC (OH-THC); phase II metabolite 11-nor-9-carboxy-THC (THC-COOH); and THC-COOH glucuronide. For THC and all other analytes, the peak concentration (Cmax) will be derived using a linear noncompartmental analysis., Up to 8 hours|Time to attain Cmax concentration (Tmax), Serial blood samples will be collected for plasma levels of THC; its phase I metabolite 11-hydroxy-THC (OH-THC); phase II metabolite 11-nor-9-carboxy-THC (THC-COOH); and THC-COOH glucuronide. For THC and all other analytes, the time to attain Cmax concentration (Tmax) will be derived using a linear noncompartmental analysis., Up to 8 hours|Area under the plasma concentration-time curve (AUC0-8h), Serial blood samples will be collected for plasma levels of THC; its phase I metabolite 11-hydroxy-THC (OH-THC); phase II metabolite 11-nor-9-carboxy-THC (THC-COOH); and THC-COOH glucuronide. For THC and all other analytes, the area under the plasma concentration-time curve (AUC0-8h) will be derived using a linear noncompartmental analysis., Up to 8 hours|Nociception, Multimodal quantitative sensory testing (QST) will be used ensure that various types of afferent fibers are engaged, so that the analgesic efficacy of THC can be comprehensively investigated. A composite pain sensitivity measure as a Z-score (ranging from -1 to +1) will be derived from the QST battery, with greater scores indicating a higher sensitivity to pain., Up to 8 hours|Abuse Liability, A modified Multiple-Choice Procedure (MPC) will be used to measure abuse liability. The MCP was developed and validated by Roland Griffiths to efficiently assess drug reinforcement - including cannabinoid-induced reinforcement. In each of the 6 experimental sessions, participants will choose between forfeiting or receiving escalating sums of money, on a scale of values between -$20.00 and $20.00; or re-receiving the study medication assigned for that day. The primary outcome will be the crossover point, the value at which the participant chooses money rather than the study medication, which will be determined for each session., Up to 8 hours
- Sponsor Collaborator
- Yale University|VA Connecticut Healthcare System|National Institute on Drug Abuse (NIDA)
- Funded By
- OTHER
- Location
- VA Connecticut Healthcare System, West Haven, Connecticut, 06516, United States
- Other Id
- 2000035354|1R21DA057240-01
- Start Date
- 2023-10-17
- Primary Completion Date
- 2025-04-30
- Completion Date
- 2025-04-30
- First Posted
- 2023-06-18
- Results First Posted
- Last Update Posted
- 2024-01-23
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05906511
- Title Cn
- Title En
- PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults
- Bilingual Status
- semi_complete