Cannabis UsePhase 1NCT05602649
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
A Phase 1 study testing Cannabis in people with Cannabis Use, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Tory Spindle, PhD, 410-550-0529, tspindle@jhmi.edu
About this study
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.
Read the 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.
- Conditions
- Cannabis Use
- Being tested
- Cannabis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called marijuana
Cannabis will be orally ingested
PlaceboDrug
Placebo will be orally ingested
| Study group | Role | What they receive |
|---|---|---|
| Placebo Gummy | Placebo comparator | Participants will self-administer a gummy containing 0mg THC Receives: Drug: Placebo |
| Low Dose Gummy | Experimental | Participants will self-administer a gummy containing 10mg THC Receives: Drug: Cannabis |
| High Dose Gummy | Experimental | Participants will self-administer a gummy containing 25mg THC Receives: Drug: Cannabis |
| Placebo Chocolate | Placebo comparator | Participants will self-administer chocolate containing 0mg THC Receives: Drug: Placebo |
| Low Dose Chocolate | Experimental | Participants will self-administer chocolate containing 10mg THC Receives: Drug: Cannabis |
| High Dose Chocolate | Experimental | Participants will self-administer chocolate containing 25mg THC Receives: Drug: Cannabis |
| Placebo Beverage | Placebo comparator | Participants will self-administer a beverage containing 0mg THC Receives: Drug: Placebo |
| Low Dose Beverage | Experimental | Participants will self-administer a beverage containing 10mg THC Receives: Drug: Cannabis |
| High Dose Beverage | Experimental | Participants will self-administer a beverage containing 25mg THC Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 hours
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).
Measured: 8 hours
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).
Measured: 8 hours
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).
Measured: 8 hours
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).
Measured: 8 hours
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).
Measured: 8 hours
"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.
Measured: 8 hours
"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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
Secondary outcomes (22)
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 8 hours
"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.
Measured: 8 hours
"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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start10 Jul 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all dose conditions in a randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602649
- Sponsor's protocol ID
- IRB00354926
- Other IDs
- 1R01DA057201-01
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
- ClinicalTrials.gov ID
- NCT05602649
- Acronym / sponsor ID
- IRB00354926
- Conditions
- Cannabis Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- All participants will complete all dose conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Placebo Gummy | Placebo comparator | Drug: PlaceboParticipants will self-administer a gummy containing 0mg THC |
| Low Dose Gummy | Experimental | Drug: CannabisParticipants will self-administer a gummy containing 10mg THC |
| High Dose Gummy | Experimental | Drug: CannabisParticipants will self-administer a gummy containing 25mg THC |
| Placebo Chocolate | Placebo comparator | Drug: PlaceboParticipants will self-administer chocolate containing 0mg THC |
| Low Dose Chocolate | Experimental | Drug: CannabisParticipants will self-administer chocolate containing 10mg THC |
| High Dose Chocolate | Experimental | Drug: CannabisParticipants will self-administer chocolate containing 25mg THC |
| Placebo Beverage | Placebo comparator | Drug: PlaceboParticipants will self-administer a beverage containing 0mg THC |
| Low Dose Beverage | Experimental | Drug: CannabisParticipants will self-administer a beverage containing 10mg THC |
| High Dose Beverage | Experimental | Drug: CannabisParticipants will self-administer a beverage containing 25mg THC |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisAlso: marijuanaCannabis will be orally ingested | Drug | High Dose Beverage, High Dose Chocolate, High Dose Gummy, Low Dose Beverage, Low Dose Chocolate, Low Dose Gummy |
| PlaceboPlacebo will be orally ingested | Drug | Placebo Beverage, Placebo Chocolate, Placebo Gummy |
Primary outcome
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Time frame: 8 hours
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)
Time frame: 8 hours
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)
Time frame: 8 hours
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)
Time frame: 8 hours
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
Time frame: 8 hours
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
Time frame: 8 hours
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)
Time frame: 8 hours
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
Time frame: 8 hours
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
Time frame: 8 hours
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
Time frame: 8 hours
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.
22 secondary outcomes
CMax for THC metabolite - 11-OH-THC
Time frame: 8 hours
CMax for THC metabolite- THCCOOH
Time frame: 8 hours
AUC for THC metabolite - 11-OH-THC
Time frame: 8 hours
AUC for THC metabolite - THCCOOH
Time frame: 8 hours
Tmax for THC
Time frame: 8 hours
Tmax for THC metabolite - 11-OH-THC
Time frame: 8 hours
Tmax for THC metabolite - THCCOOH
Time frame: 8 hours
Cmax for CBD
Time frame: 8 hours
Cmax for CBN
Time frame: 8 hours
Cmax for CBG
Time frame: 8 hours
AUC for CBD
Time frame: 8 hours
AUC for CBN
Time frame: 8 hours
AUC for CBG
Time frame: 8 hours
Tmax for CBD
Time frame: 8 hours
Tmax for CBN
Time frame: 8 hours
Tmax for CBG
Time frame: 8 hours
Psychomotor performance as assessed by attempted Trials on the Digit Symbol Substitution Task(DSST)
Time frame: 8 hours
Working memory performance as assessed by Reaction Time on Paced Auditory Serial Addition Task (PASAT)
Time frame: 8 hours
Attention as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Time frame: 8 hours
Executive functioning as assessed by the Number of peripheral integers correct on Divided Attention Task (DAT)
Time frame: 8 hours
"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire
Time frame: 8 hours
"Feel Drug Effect" as assessed by the Drug Effect Questionnaire-
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tory Spindle, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis in people with Cannabis Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tory Spindle, PhD (410-550-0529, tspindle@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory performance as assessed by the Correct Trials on Paced Auditory Serial Addition Task (PASAT) (time frame: 8 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.