Cannabis IntoxicationPhase 1NCT07870187
Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)
A Phase 1 study testing 0mg THC + 0mg CBD Brownie, 10mg THC + 0mg CBD Brownie and 10mg THC + 10mg CBD Brownie in people with Cannabis Intoxication, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Intoxication
- What is being tested?
- 0mg THC + 0mg CBD Brownie, 10mg THC + 0mg CBD Brownie and 10mg THC + 10mg CBD Brownie
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Feb 2029
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 21 years old;
- be in good general health based on screening procedures (e.g., physical exam, EKG, blood testing, psychiatric evaluation);
- have vital signs in normal range;
- have not donated blood in past 30 days;
- not be pregnant (assessed via blood serum at screening and urinalysis before each study session) or breast feeding (women only);
- have a body mass index (BMI) in the range of 18 to 36 kg/m^2;
- report using cannabis in the last 3 years, but not in the past month;
- negative urine test for illicit drug use (including THC) and negative breath alcohol test (0% breath alcohol concentration) at screening and before study sessions.
Who cannot join
- psychoactive drug use (aside from nicotine, alcohol, or caffeine) in past month;
- current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety or pharmacokinetics (PK) of the study drugs;
- history of or current evidence of significant medical condition;
- evidence of current psychiatric condition (based on MINI);
- been in treatment previously for cannabis use disorder;
- liver function tests more than 2x normal range;
- enrollment in another clinical trial or receiving of any drug as part of research within past 30 days;
- epilepsy or a history of seizures
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
Johns Hopkins University
Baltimore, Maryland, 21224
Carlos A Zamarripa, PhD, 410-550-6969, czamarr2@jhmi.edu
About this study
This study will evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol
Read the detailed description
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, or 10mg THC; 0, 10, 50, 100, 300mg CBD). Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, simulated driving performance, and impact on blood pharmacokinetics.
- Conditions
- Cannabis Intoxication
- Being tested
- 0mg THC + 0mg CBD Brownie, 10mg THC + 0mg CBD Brownie, 10mg THC + 10mg CBD Brownie, 10mg THC + 50mg CBD Brownie, 10mg THC + 100mg CBD Brownie
- Keywords
- Cannabis, delta-9-tetrahydrocannabinol, cannabidiol
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0mg THC + 0mg CBD BrownieDrug
Brownie containing no THC and CBD will be self administered through oral ingestion.
10mg THC + 0mg CBD BrownieDrug
Brownie containing 10mg THC and no CBD will be self administered through oral ingestion.
10mg THC + 10mg CBD BrownieDrug
Brownie containing 10mg THC and 10mg CBD will be self administered through oral ingestion.
10mg THC + 50mg CBD BrownieDrug
Brownie containing 10mg THC and 50mg CBD will be self administered through oral ingestion.
10mg THC + 100mg CBD BrownieDrug
Brownie containing 10mg THC and 100mg CBD will be self administered through oral ingestion.
10mg THC + 300mg CBD BrownieDrug
Brownie containing 10mg THC and 300mg CBD will be self administered through oral ingestion.
0mg THC + 300mg CBD BrownieDrug
Brownie containing no THC and 300mg CBD will be self administered through oral ingestion.
| Study group | Role | What they receive |
|---|---|---|
| 0mg THC + 0mg CBD | Placebo comparator | Participants ingest a brownie containing 0mg THC and 0mg CBD. Receives: Drug: 0mg THC + 0mg CBD Brownie |
| 10mg THC + 0mg CBD | Experimental | Participants ingest a brownie containing 10mg THC and 0mg CBD. Receives: Drug: 10mg THC + 0mg CBD Brownie |
| 10mg THC + 10mg CBD | Experimental | Participants ingest a brownie containing 10mg THC and 10mg CBD. Receives: Drug: 10mg THC + 10mg CBD Brownie |
| 10mg THC + 50mg CBD | Experimental | Participants ingest a brownie containing 10mg THC and 50mg CBD. Receives: Drug: 10mg THC + 50mg CBD Brownie |
| 10mg THC + 100mg CBD | Experimental | Participants ingest a brownie containing 10mg THC and 100mg CBD. Receives: Drug: 10mg THC + 100mg CBD Brownie |
| 10mg THC + 300mg CBD | Experimental | Participants ingest a brownie containing 10mg THC and 300mg CBD. Receives: Drug: 10mg THC + 300mg CBD Brownie |
| 0mg THC + 300mg CBD | Experimental | Participants ingest a brownie containing 0mg THC and 300mg CBD. Receives: Drug: 0mg THC + 300mg CBD Brownie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving performance as assessed by standard deviation of lateral position (SDLP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Measured: Baseline, , 2-, 4-, 6-, 8-hours post dosing.
Number of 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. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Driving Under the Influence of Drugs (DRUID) application global impairment score
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Driving performance as assessed by global drive score during the simulated driving task
Driving impairment will be assessed using a composite driving score, with higher scores indicating greater impairment. The composite score is calculated by converting individual driving outcomes (see primary and secondary driving outcomes) into standardized z-scores and averaging these values to generate an overall composite score. Individual z-scores have a mean of 0 and a standard deviation (SD) of 1 in the reference sample used for standardization. The composite score has an expected mean of 0 in the reference sample, while its SD depends on the correlations among the individual driving outcomes and is not necessarily 1.
Measured: Baseline, 2, 4, 6, and 8 hours post-dosing.
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Drug Effect Questionnaire (DEQ) - Drug Liking
The DEQ will be used to obtain subjective ratings of "drug liking". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Drug Effect Questionnaire - Confidence to Drive
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Heart Rate - Beats per Minute
Beats per minute will be used to assess affects on heart rate.
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Whole Blood Concentrations - THC Concentrations
Blood THC concentrations will be measured to assess changing in blood concentrations following drug administration.
Measured: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis IntoxicationStudies 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 (study arms) in a randomized order
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 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
- Carlos A Zamarripa, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870187
- Sponsor's protocol ID
- IRB00574630
- Other IDs
- R01DA064583
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)
- ClinicalTrials.gov ID
- NCT07870187
- Acronym / sponsor ID
- IRB00574630
- Conditions
- Cannabis Intoxication
- Keywords
- Cannabis, delta-9-tetrahydrocannabinol, cannabidiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 13 Oct 2026 (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 evaluate the subjective and behavioral effects of cannabis products containing delta-9-tetrahydrocannabinol and cannabidiol
Detailed description
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, or 10mg THC; 0, 10, 50, 100, 300mg CBD). Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, simulated driving performance, and impact on blood pharmacokinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
| Arm | Type | Receives |
|---|---|---|
| 0mg THC + 0mg CBD | Placebo comparator | Drug: 0mg THC + 0mg CBD BrownieParticipants ingest a brownie containing 0mg THC and 0mg CBD. |
| 10mg THC + 0mg CBD | Experimental | Drug: 10mg THC + 0mg CBD BrownieParticipants ingest a brownie containing 10mg THC and 0mg CBD. |
| 10mg THC + 10mg CBD | Experimental | Drug: 10mg THC + 10mg CBD BrownieParticipants ingest a brownie containing 10mg THC and 10mg CBD. |
| 10mg THC + 50mg CBD | Experimental | Drug: 10mg THC + 50mg CBD BrownieParticipants ingest a brownie containing 10mg THC and 50mg CBD. |
| 10mg THC + 100mg CBD | Experimental | Drug: 10mg THC + 100mg CBD BrownieParticipants ingest a brownie containing 10mg THC and 100mg CBD. |
| 10mg THC + 300mg CBD | Experimental | Drug: 10mg THC + 300mg CBD BrownieParticipants ingest a brownie containing 10mg THC and 300mg CBD. |
| 0mg THC + 300mg CBD | Experimental | Drug: 0mg THC + 300mg CBD BrownieParticipants ingest a brownie containing 0mg THC and 300mg CBD. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- at least 21 years old;
- be in good general health based on screening procedures (e.g., physical exam, EKG, blood testing, psychiatric evaluation);
- have vital signs in normal range;
- have not donated blood in past 30 days;
- not be pregnant (assessed via blood serum at screening and urinalysis before each study session) or breast feeding (women only);
Key exclusion criteria (8 listed)
- psychoactive drug use (aside from nicotine, alcohol, or caffeine) in past month;
- current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety or pharmacokinetics (PK) of the study drugs;
- history of or current evidence of significant medical condition;
- evidence of current psychiatric condition (based on MINI);
- been in treatment previously for cannabis use disorder;
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 |
|---|---|---|
| 0mg THC + 0mg CBD BrownieBrownie containing no THC and CBD will be self administered through oral ingestion. | Drug | 0mg THC + 0mg CBD |
| 10mg THC + 0mg CBD BrownieBrownie containing 10mg THC and no CBD will be self administered through oral ingestion. | Drug | 10mg THC + 0mg CBD |
| 10mg THC + 10mg CBD BrownieBrownie containing 10mg THC and 10mg CBD will be self administered through oral ingestion. | Drug | 10mg THC + 10mg CBD |
| 10mg THC + 50mg CBD BrownieBrownie containing 10mg THC and 50mg CBD will be self administered through oral ingestion. | Drug | 10mg THC + 50mg CBD |
| 10mg THC + 100mg CBD BrownieBrownie containing 10mg THC and 100mg CBD will be self administered through oral ingestion. | Drug | 10mg THC + 100mg CBD |
| 10mg THC + 300mg CBD BrownieBrownie containing 10mg THC and 300mg CBD will be self administered through oral ingestion. | Drug | 10mg THC + 300mg CBD |
| 0mg THC + 300mg CBD BrownieBrownie containing no THC and 300mg CBD will be self administered through oral ingestion. | Drug | 0mg THC + 300mg CBD |
Primary outcome
Driving performance as assessed by standard deviation of lateral position (SDLP)
Time frame: Baseline, , 2-, 4-, 6-, 8-hours post dosing.
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Driving Under the Influence of Drugs (DRUID) application global impairment score
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Driving performance as assessed by global drive score during the simulated driving task
Time frame: Baseline, 2, 4, 6, and 8 hours post-dosing.
Driving impairment will be assessed using a composite driving score, with higher scores indicating greater impairment. The composite score is calculated by converting individual driving outcomes (see primary and secondary driving outcomes) into standardized z-scores and averaging these values to generate an overall composite score. Individual z-scores have a mean of 0 and a standard deviation (SD) of 1 in the reference sample used for standardization. The composite score has an expected mean of 0 in the reference sample, while its SD depends on the correlations among the individual driving outcomes and is not necessarily 1.
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire (DEQ) - Drug Liking
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
The DEQ will be used to obtain subjective ratings of "drug liking". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire - Confidence to Drive
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Heart Rate - Beats per Minute
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Beats per minute will be used to assess affects on heart rate.
Whole Blood Concentrations - THC Concentrations
Time frame: Baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Blood THC concentrations will be measured to assess changing in blood concentrations following drug administration.
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 15 Oct 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.
Carlos A Zamarripa, 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 0mg THC + 0mg CBD Brownie, 10mg THC + 0mg CBD Brownie and 10mg THC + 10mg CBD Brownie in people with Cannabis Intoxication, 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: opening soon, as of the sponsor's last update on 15 Oct 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 Carlos A Zamarripa, PhD (410-550-6969, czamarr2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving performance as assessed by standard deviation of lateral position (SDLP) (time frame: Baseline, , 2-, 4-, 6-, 8-hours post dosing.). 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 15 Oct 2026.