CannabisPhase 1NCT06218550
Delta-8-THC vs. Delta-9-THC on Simulated Driving Performance
A Phase 1 study testing Delta-9-THC and Delta-8-THC in people with Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Delta-9-THC and Delta-8-THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 8 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Test negative for recent cannabis use prior to each experimental test session
- Test negative for drugs of abuse and alcohol prior to each experimental test session
- 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 clinic admission
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Show all 9Show fewer
- Report use of cannabis in the past 3 years (both sub-studies) and prior experience inhaling cannabis (either via smoking or vaporization) for vaporization sub-study participation
- Have not donated blood in the prior 30 days.
- Have a current government-issued driver's license
Who cannot join
- Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
- History of or current evidence of health issues 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.
- Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
- History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
- Participation in other research projects that could impact the present study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
Official title: The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment
Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.
Read the detailed description
The present study will characterize the acute effects of oral and inhaled ∆8-THC, compared with a positive control dose of ∆9-THC and placebo, on subjective drug effects, cardiovascular effects, cognitive performance, simulated driving performance, field sobriety tests, and drug testing outcomes in oral fluid, blood, hair, and urine. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The result will be a comparative pharmacology and toxicology dataset for ∆8-THC and ∆9-THC via both oral ingestion and inhalation, two routes of administration that are predominant in retail products currently being sold across the U.S. This study will provide urgently needed data on the behavioral pharmacology and toxicology of ∆8-THC, a novel cannabinoid that is now widely available, but for which there is little public knowledge or public health messaging. This data will directly inform the impact of ∆8-THC use on drug testing programs, and the comparative effects of ∆8-THC to ∆9-THC can be used to inform regulatory decisions related to public safety and the sale of these products.
- Conditions
- Cannabis
- Being tested
- Delta-9-THC, Delta-8-THC, Placebo
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta-9-THCDrug
Acute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers
Delta-8-THCDrug
Acute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers
PlaceboDrug
Consumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo | Placebo comparator | A brownie containing no experimental drugs will be eaten by study participants Receives: Drug: Placebo |
| Oral administration of 30mg ∆8-THC | Experimental | A brownie infused with 30mg ∆8-THC will be eaten by study participants Receives: Drug: Delta-8-THC |
| Oral administration of 60mg ∆8-THC | Experimental | A brownie infused with 60mg ∆8-THC will be eaten by study participants Receives: Drug: Delta-8-THC |
| Oral administration of 30mg ∆9-THC | Experimental | A brownie infused with 30mg ∆9-THC will be eaten by study participants Receives: Drug: Delta-9-THC |
| Administration of vaporized Placebo | Placebo comparator | Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs") Receives: Drug: Placebo |
| Administration of vaporized 30mg ∆8-THC | Experimental | Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") Receives: Drug: Delta-8-THC |
| Administration of vaporized 60mg ∆8-THC | Experimental | Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") Receives: Drug: Delta-8-THC |
| Administration of vaporized 30mg ∆9-THC | Experimental | Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs") Receives: Drug: Delta-9-THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP) in cm
A measure of lane weaving during simulated driving performance, the standard deviation of lateral position is a standard metric of impairment in driving performance. A score of 0 (perfect score, no deviation) is the minimum score possible and there is no upper threshold score. Higher scores equate to worse performance (more lane weaving).
Measured: 0-8 hours
Secondary outcomes (2)
Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)
Peak rating (0-100) of Drug Effect on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No drug effect and 100 being maximum drug effect
Measured: 0-8 hours
Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App
Peak Global Impairment score (0-75) recorded as a result of performance on the DRUID App, a brief cognitive task battery completed on a mobile device (e.g., iPad). Larger scores indicate worse performance on the task.
Measured: 0-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jul 2024
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies 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
- A within-subjects design. At the time of study randomization, participants will be assigned to complete Sub-Study 1 followed by Sub-Study 2, or vice versa, using a counter-balanced randomization sequence. The order in which dose conditions are administered within each sub-study will be randomized across participants because there are too many drug conditions to fully counterbalance dosing within sub-studies at the proposed sample size.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218550
- Sponsor's protocol ID
- IRB00394164
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2024
- Last updated
- 20 Jul 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Delta-8-THC vs Delta-9-THC on Simulated Driving Performance and Measures of Impairment
- ClinicalTrials.gov ID
- NCT06218550
- Acronym / sponsor ID
- IRB00394164
- Conditions
- Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 23 Jan 2024 (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.
Delta-8-THC is an isomer of delta-9-THC that has become widely available due to the legalization of hemp and its derivatives. Very little controlled research has been conducted with delta-8-THC and some research suggests it produces similar effects to delta-9-THC, albeit at lower potency. The present study will evaluate the dose effects of delta-8-THC, compared with delta-9-THC, on simulated driving performance, field sobriety tests, cognitive performance, and biomarkers of exposure to cannabinoids. The results will inform policy and education related to impairment due to acute delta-8-THC exposure via vaporization and oral ingestion.
Detailed description
The present study will characterize the acute effects of oral and inhaled ∆8-THC, compared with a positive control dose of ∆9-THC and placebo, on subjective drug effects, cardiovascular effects, cognitive performance, simulated driving performance, field sobriety tests, and drug testing outcomes in oral fluid, blood, hair, and urine. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The result will be a comparative pharmacology and toxicology dataset for ∆8-THC and ∆9-THC via both oral ingestion and inhalation, two routes of administration that are predominant in retail products currently being sold across the U.S. This study will provide urgently needed data on the behavioral pharmacology and toxicology of ∆8-THC, a novel cannabinoid that is now widely available, but for which there is little public knowledge or public health messaging. This data will directly inform the impact of ∆8-THC use on drug testing programs, and the comparative effects of ∆8-THC to ∆9-THC can be used to inform regulatory decisions related to public safety and the sale of these products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- Model description
- A within-subjects design. At the time of study randomization, participants will be assigned to complete Sub-Study 1 followed by Sub-Study 2, or vice versa, using a counter-balanced randomization sequence. The order in which dose conditions are administered within each sub-study will be randomized across participants because there are too many drug conditions to fully counterbalance dosing within sub-studies at the proposed sample size.
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo | Placebo comparator | Drug: PlaceboA brownie containing no experimental drugs will be eaten by study participants |
| Oral administration of 30mg ∆8-THC | Experimental | Drug: Delta-8-THCA brownie infused with 30mg ∆8-THC will be eaten by study participants |
| Oral administration of 60mg ∆8-THC | Experimental | Drug: Delta-8-THCA brownie infused with 60mg ∆8-THC will be eaten by study participants |
| Oral administration of 30mg ∆9-THC | Experimental | Drug: Delta-9-THCA brownie infused with 30mg ∆9-THC will be eaten by study participants |
| Administration of vaporized Placebo | Placebo comparator | Drug: PlaceboParticipants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs") |
| Administration of vaporized 30mg ∆8-THC | Experimental | Drug: Delta-8-THCParticipants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") |
| Administration of vaporized 60mg ∆8-THC | Experimental | Drug: Delta-8-THCParticipants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs") |
| Administration of vaporized 30mg ∆9-THC | Experimental | Drug: Delta-9-THCParticipants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs") |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Test negative for recent cannabis use prior to each experimental test session
- Test negative for drugs of abuse and alcohol prior to each experimental test session
- 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 clinic admission
Key exclusion criteria (5 listed)
- Non-medical use of psychoactive drugs other than nicotine, alcohol, or caffeine in the month prior to study participation.
- History of or current evidence of health issues 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.
- Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC).
- History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
- Participation in other research projects that could impact the present study
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 |
|---|---|---|
| Delta-9-THCAcute self-administration of inhaled or oral ∆9-THC by healthy adult research volunteers | Drug | Administration of vaporized 30mg ∆9-THC, Oral administration of 30mg ∆9-THC |
| Delta-8-THCAcute self-administration of inhaled or oral ∆8-THC by healthy adult research volunteers | Drug | Administration of vaporized 30mg ∆8-THC, Administration of vaporized 60mg ∆8-THC, Oral administration of 30mg ∆8-THC, Oral administration of 60mg ∆8-THC |
| PlaceboConsumption of a brownie or inhalation of ambient air through a cannabis vaporizer by health adult research volunteers | Drug | Administration of vaporized Placebo, Oral Placebo |
Primary outcome
Standard Deviation of Lateral Position (SDLP) in cm
Time frame: 0-8 hours
A measure of lane weaving during simulated driving performance, the standard deviation of lateral position is a standard metric of impairment in driving performance. A score of 0 (perfect score, no deviation) is the minimum score possible and there is no upper threshold score. Higher scores equate to worse performance (more lane weaving).
2 secondary outcomes
Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 0-8 hours
Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App
Time frame: 0-8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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. This study is not recruiting at the moment.
Ryan Vandrey, 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 Delta-9-THC and Delta-8-THC in people with Cannabis, 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Lateral Position (SDLP) in cm (time frame: 0-8 hours). 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 20 Jul 2026.