Back to resultsThe Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Primary Purpose
Cannabis Use
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria Have provided written informed consent. Be between the ages of 21 and 55. Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests). Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions. 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 admission for each session. Have prior experience using THC-dominant cannabis. Have a body mass index (BMI) in the range of 16 to 38 kg/m2. Have not donated blood in the past 30 days. Exclusion Criteria Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days. History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products. Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B. History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes. Evidence of current psychiatric condition (based on MINI for DSM-5). Been in treatment previously for cannabis use disorder. Receiving of any drug as part of a research study within the past 30 days. History of epilepsy or other serious medical condition.
Sites / Locations
- Johns Hopkins Behavioral Pharmacology Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo Gummy
Low Dose Gummy
High Dose Gummy
Placebo Chocolate
Low Dose Chocolate
High Dose Chocolate
Placebo Beverage
Low Dose Beverage
High Dose Beverage
Arm Description
Participants will self-administer a gummy containing 0mg THC
Participants will self-administer a gummy containing 10mg THC
Participants will self-administer a gummy containing 25mg THC
Participants will self-administer chocolate containing 0mg THC
Participants will self-administer chocolate containing 10mg THC
Participants will self-administer chocolate containing 25mg THC
Participants will self-administer a beverage containing 0mg THC
Participants will self-administer a beverage containing 10mg THC
Participants will self-administer a beverage containing 25mg THC
Outcomes
Primary Outcome Measures
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (lower scores indicate worse performance).
Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90 seconds is primary outcome (lower scores indicate worse performance).
Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Computerized version of the Divided Attention Task will be administered to assess attention. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Computerized version of the Divided Attention Task will be administered to assess executive functioning. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment
Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
DRUID application global impairment score - Acute behavioral impairment
Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
"Want to take again" as assessed by the Drug Effect Questionnaire
The DEQ will be used to obtain subjective ratings of "want to take drug again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
CMax for THC
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
AUC for THC
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Secondary Outcome Measures
CMax for THC metabolite - 11-OH-THC
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
CMax for THC metabolite- THCCOOH
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
AUC for THC metabolite - 11-OH-THC
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
AUC for THC metabolite - THCCOOH
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Tmax for THC
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Tmax for THC metabolite - 11-OH-THC
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Tmax for THC metabolite - THCCOOH
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Cmax for CBD
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Cmax for CBN
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Cmax for CBG
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
AUC for CBD
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
AUC for CBN
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
AUC for CBG
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Tmax for CBD
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Tmax for CBN
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Tmax for CBG
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Number of attempted trials is a secondary outcome.
Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The secondary outcome is the mean reaction time (in milliseconds) to select correct responses.
Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Computerized version of the Divided Attention Task will be administered to assess attention. The secondary outcome is the number of peripheral stimuli correctly identified.
Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Computerized version of the Divided Attention Task will be administered to assess executive functioning. The secondary outcome is the number of peripheral stimuli correctly identified.
"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire
The DEQ will be used to obtain subjective ratings of "unpleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
"Feel Drug Effect" as assessed by the Drug Effect Questionnaire-
The DEQ will be used to obtain subjective ratings of "feel drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Full Information
NCT ID
NCT05602649
First Posted
October 27, 2022
Last Updated
July 6, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05602649
Brief Title
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Official Title
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.
Detailed Description
The purpose of this study is to examine the pharmacokinetics (PK) and pharmacodynamics (PD) of 3 popular types of cannabis edibles: THC-infused chocolates, gummies, and drinks. This study will utilize a rigorous double-blind, placebo-controlled, within-subjects design. Healthy adults (N=40; 20 males, 20 females) will complete 9 outpatient drug administration sessions in a randomized order. After 8 hours of monitored fasting, participants will consume 1 of 3 types of edibles (chocolates, gummies, or drinks) that are representative of current retail cannabis products. Products will contain 0 (placebo), 10, or 25mg THC. PD assessments include a battery of cognitive/psychomotor performance tasks shown to be sensitive to oral cannabis at these doses and subjective drug effects. Blood samples will be drawn to measure THC and its primary metabolites. Vital signs will be recorded. These procedures will be completed during each of the 9 study sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
All participants will complete all dose conditions in a randomized order.
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind, placebo controlled
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Gummy
Arm Type
Placebo Comparator
Arm Description
Participants will self-administer a gummy containing 0mg THC
Arm Title
Low Dose Gummy
Arm Type
Experimental
Arm Description
Participants will self-administer a gummy containing 10mg THC
Arm Title
High Dose Gummy
Arm Type
Experimental
Arm Description
Participants will self-administer a gummy containing 25mg THC
Arm Title
Placebo Chocolate
Arm Type
Placebo Comparator
Arm Description
Participants will self-administer chocolate containing 0mg THC
Arm Title
Low Dose Chocolate
Arm Type
Experimental
Arm Description
Participants will self-administer chocolate containing 10mg THC
Arm Title
High Dose Chocolate
Arm Type
Experimental
Arm Description
Participants will self-administer chocolate containing 25mg THC
Arm Title
Placebo Beverage
Arm Type
Placebo Comparator
Arm Description
Participants will self-administer a beverage containing 0mg THC
Arm Title
Low Dose Beverage
Arm Type
Experimental
Arm Description
Participants will self-administer a beverage containing 10mg THC
Arm Title
High Dose Beverage
Arm Type
Experimental
Arm Description
Participants will self-administer a beverage containing 25mg THC
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
marijuana
Intervention Description
Cannabis will be orally ingested
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be orally ingested
Primary Outcome Measure Information:
Title
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Description
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (lower scores indicate worse performance).
Time Frame
8 hours
Title
Psychomotor performance as assessed by the Correct Trials on the Digit Symbol Substitution Task(DSST)
Description
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90 seconds is primary outcome (lower scores indicate worse performance).
Time Frame
8 hours
Title
Attention as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Description
Computerized version of the Divided Attention Task will be administered to assess attention. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
Time Frame
8 hours
Title
Executive functioning as assessed by the Mean Distance from the Center Target Stimulus on the Divided Attention Task (DAT)
Description
Computerized version of the Divided Attention Task will be administered to assess executive functioning. Mean distance (in computer pixels) of the mouse cursor from the center target stimulus is primary outcome (lower scores indicate worse performance).
Time Frame
8 hours
Title
DRiving Under the Influence of Drugs (DRUID) application global impairment score - Acute cognitive impairment
Description
Acute cognitive impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Time Frame
8 hours
Title
DRUID application global impairment score - Acute behavioral impairment
Description
Acute behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Time Frame
8 hours
Title
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
Description
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
8 hours
Title
"Want to take again" as assessed by the Drug Effect Questionnaire
Description
The DEQ will be used to obtain subjective ratings of "want to take drug again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
8 hours
Title
CMax for THC
Description
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
AUC for THC
Description
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
CMax for THC metabolite - 11-OH-THC
Description
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
CMax for THC metabolite- THCCOOH
Description
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
AUC for THC metabolite - 11-OH-THC
Description
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Title
AUC for THC metabolite - THCCOOH
Description
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Title
Tmax for THC
Description
Blood concentrations of THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Tmax for THC metabolite - 11-OH-THC
Description
Blood concentrations of 11-OH-THC will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Tmax for THC metabolite - THCCOOH
Description
Blood concentrations of THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Cmax for CBD
Description
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
Cmax for CBN
Description
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
Cmax for CBG
Description
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentrations (Cmax) is determined as the highest concentration reached for each individual.
Time Frame
8 hours
Title
AUC for CBD
Description
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Title
AUC for CBN
Description
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Title
AUC for CBG
Description
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Time Frame
8 hours
Title
Tmax for CBD
Description
Blood concentrations of CBD will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Tmax for CBN
Description
Blood concentrations of CBN will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Tmax for CBG
Description
Blood concentrations of CBG will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. Time to max concentration (Tmax) will be calculated for each cannabinoid.
Time Frame
8 hours
Title
Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)
Description
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Number of attempted trials is a secondary outcome.
Time Frame
8 hours
Title
Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)
Description
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The secondary outcome is the mean reaction time (in milliseconds) to select correct responses.
Time Frame
8 hours
Title
Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Description
Computerized version of the Divided Attention Task will be administered to assess attention. The secondary outcome is the number of peripheral stimuli correctly identified.
Time Frame
8 hours
Title
Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Description
Computerized version of the Divided Attention Task will be administered to assess executive functioning. The secondary outcome is the number of peripheral stimuli correctly identified.
Time Frame
8 hours
Title
"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire
Description
The DEQ will be used to obtain subjective ratings of "unpleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
8 hours
Title
"Feel Drug Effect" as assessed by the Drug Effect Questionnaire-
Description
The DEQ will be used to obtain subjective ratings of "feel drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Have provided written informed consent.
Be between the ages of 21 and 55.
Be in good general health based on screening procedures (e.g., physical exam, medical history interview, vital signs, routine blood tests).
Test negative for illicit drugs (including cannabis) and test negative for alcohol (0% BAC) at screening and before any study sessions.
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 admission for each session.
Have prior experience using THC-dominant cannabis.
Have a body mass index (BMI) in the range of 16 to 38 kg/m2.
Have not donated blood in the past 30 days.
Exclusion Criteria
Self-reported use of illicit drugs (e.g., amphetamine, cannabis, cocaine, methamphetamine, MDMA, LSD, ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days.
History of significant allergic reaction or significant hypersensitivity to cannabis or to any of the other ingredients in the study products.
Current concomitant medication use that may interact with the study drug including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B.
History of or current evidence of a significant medical condition that, in the opinion of the investigator or medical staff, will impact the participant's safety or interfere with study outcomes.
Evidence of current psychiatric condition (based on MINI for DSM-5).
Been in treatment previously for cannabis use disorder.
Receiving of any drug as part of a research study within the past 30 days.
History of epilepsy or other serious medical condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tory Spindle, PhD
Phone
410-550-0529
Email
tspindle@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Howard
Phone
410-550-0009
Email
lhowar29@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tory Spindle, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
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