Phase 1
N=22
Interactions Between Cannabinoids and Cytochrome P450-Metabolized Drugs
Drug-Interactions
Bottom Line
View on ClinicalTrials.gov: NCT04201197 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Losartan Area Under the Curve (AUC) in Plasma — 164; 185; 289 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Inje cocktail (Drug); THC Cannabis extract (Drug); THC/CBD Cannabis Extract (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Losartan Area Under the Curve (AUC) in Plasma |
164; 185; 289 | — |
| PRIMARY Peak Change From Baseline Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT) |
-1.1; -6.6; -22.7 | — |
| PRIMARY Peak Change From Baseline Cognitive Performance as Assessed by the Divided Attention Task |
-2.1; 15.9; 32.7 | — |
| PRIMARY Drug Effect Questionnaire (DEQ) - Peak Score for Feel Drug Effect |
9.4; 59.2; 72.8 | — |
| PRIMARY Number of Correct Trials on the Digit Symbol Substitution Task (DSST) |
2.5; -2.7; -9.9 | — |
| PRIMARY Peak Change From Baseline Beats Per Minute for Heart Rate (HR) |
-4.4; 10.1; 25.4 | — |
| SECONDARY Caffeine AUC in Plasma |
18948; 18554; 26264 | — |
| SECONDARY Omeprazole AUC in Plasma |
385; 379; 1183 | — |
| SECONDARY Dextromethorphan AUC in Plasma |
10.4; 13.2; 13.6 | — |
| SECONDARY Midazolam AUC in Plasma |
23; 24; 36 | — |
Summary
This study will evaluate drug-drug interactions between cannabis extracts containing Tetrahydrocannabinol (THC) and THC+ Cannabinoids (CBD) and probe drugs for select CYP450 pathways including: caffeine (CYP1A2), omeprazole (CYP2C19), losartan (CYP2C9), dextromethorphan (CYP2D6), and midazolam (CYP3A).
Eligibility Criteria
Inclusion Criteria
- Healthy adult between 18-50 years old
- BMI between 18 to 34 kg/m2
- Willing to use birth control
- Willing to abstain from all medications and citrus fruits for the duration of the study
Exclusion Criteria
- Medical or psychiatric illness 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.
- Use of medications which, in the opinion of the investigator or medical staff, will interfere with the study outcomes or the safety of the participant.
- Clinically significant impairment of kidney, liver, or thyroid function (serum creatinine >1.2 mg/ml (kidney), liver function tests >3x the upper limit of normal (alanine amino transferase >99 U/L; aspartate amino transferase > 99 U/L), and thyroid stimulating hormone > 4.2 uIU/ml), or evidence of current anemia based on blood chemistry testing.
- History of adverse events associated with the ingestion of cannabis or any medications in the Inje cocktail judged by the investigator to present an undue risk of harm to the participant.
Data sourced from ClinicalTrials.gov (NCT04201197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.