Behavioral Pharmacology of CannabisPhase 1NCT05287256
Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC
A Phase 1 study testing Oral Delta-8-THC Cannabis, Oral Delta-9-THC Cannabis and Vaporized Delta-8-THC Cannabis in people with Behavioral Pharmacology of Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Pharmacology of Cannabis
- What is being tested?
- Oral Delta-8-THC Cannabis, Oral Delta-9-THC Cannabis and Vaporized Delta-8-THC Cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 2 Oct 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have provided written informed consent
- Be between the ages of 18 and 45
- 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 in urine at the screening visit and again upon admission for each experimental session
- Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental 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.
Show all 10Show fewer
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- Report prior experience inhaling cannabis (either via smoking or vaporization).
- Have not donated blood in the prior 30 days.
Who cannot join
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
- History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
- Use of any hemp, cannabis or cannabinoid product in the past 3 months.
- 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.
Show all 11Show fewer
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Epilepsy or a history of seizures.
- Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician.
- Individuals with anemia judged by medical staff to place the person at risk due to the frequency and volume of blood collected during the 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
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.
Read the detailed description
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 THC in comparison to both placebo and Delta-9 THC. Delta-8 THC is an cannabinoid that has become widely available for retail sale in the US due to a loophole in the 2018 Farm Bill. Delta-8 THC is an isomer of Delta-9 THC, which is the compound responsible for most of the psychoactive effects associated with cannabis. Prior research, while limited, has indicated that Delta-8 THC is less potent but has comparable pharmacodynamic effects to Delta-9 THC, especially at higher doses. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants. The investigators will recruit healthy participants between the ages of 18 and 45 who have prior experience using THC but have not used in at least one month. Two sub-studies will be run, with 5 conditions in each study; sub-study 1 will examine the effects of vaporized Delta-8 THC and sub-study 2 will assess the effects of orally ingested Delta-8 THC. Participants can complete both sub-studies but it is not required. There will be a minimum of 5 outpatient drug administration sessions for each participant, with the option to complete 5 more if interested. The investigators will recruit and consent up to 70 participants in order to obtain 20 completers (up to 40 total individuals) for each sub-study.
- Conditions
- Behavioral Pharmacology of Cannabis
- Being tested
- Oral Delta-8-THC Cannabis, Oral Delta-9-THC Cannabis, Oral Placebo, Vaporized Delta-8-THC Cannabis, Vaporized Delta-9-THC Cannabis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Delta-8-THC CannabisDrug
Also called marijuana
Delta-8-THC cannabis will be orally self-administered by study participants
Oral Delta-9-THC CannabisDrug
Also called marijuana
Delta-9-THC cannabis will be orally self-administered by study participants
Oral PlaceboDrug
Placebo will be orally self-administered by study participants
Vaporized Delta-8-THC CannabisDrug
Also called marijuana
Delta-8-THC cannabis will be self-administered by study participants using a vaporizer
Vaporized Delta-9-THC CannabisDrug
Also called marijuana
Delta-9-THC cannabis will be self-administered by study participants using a vaporizer
Vaporized PlaceboDrug
Placebo will be self-administered by study participants using a vaporizer
| Study group | Role | What they receive |
|---|---|---|
| Placebo Oral Cannabis | Placebo comparator | Single acute administration of placebo cannabis baked into a brownie Receives: Drug: Oral Placebo |
| Oral administration of 10mg D-8-THC | Experimental | Single acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie Receives: Drug: Oral Delta-8-THC Cannabis |
| Oral administration of 20mg D-8-THC | Experimental | Single acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie Receives: Drug: Oral Delta-8-THC Cannabis |
| Oral administration of 40mg D-8-THC | Experimental | Single acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie Receives: Drug: Oral Delta-8-THC Cannabis |
| Oral administration of 20mg D-9-THC | Experimental | Single acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie Receives: Drug: Oral Delta-9-THC Cannabis |
| Placebo Vaporized Cannabis | Placebo comparator | Single acute administration of placebo cannabis via commercial vaporizer Receives: Drug: Vaporized Placebo |
| Administration of vaporized 10mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer Receives: Drug: Vaporized Delta-8-THC Cannabis |
| Administration of vaporized 20mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer Receives: Drug: Vaporized Delta-8-THC Cannabis |
| Administration of vaporized 40mg D-8-THC | Experimental | Single acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer Receives: Drug: Vaporized Delta-8-THC Cannabis |
| Administration of vaporized 20mg D-9-THC | Experimental | Single acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer Receives: Drug: Vaporized Delta-9-THC Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.
Measured: Within 8 hours
Secondary outcomes (7)
Behavioral task performance as assessed by the DRUID app
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.
Measured: Within 8 hours
Quantitative levels of D-9-THC in blood
Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).
Measured: Within 8 hours
Quantitative levels of D-8-THC in blood
Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).
Measured: Within 8 hours
Paced Auditory Serial Addition Task (PASAT) score
Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.
Measured: Within 8 hours
Digit Symbol Substitution Task (DSST) score
Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.
Measured: Within 8 hours
Divided Attention as assessed by the DAT
Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.
Measured: Within 8 hours
Heart rate
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Measured: Within 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start23 May 2022
- Primary completion8 Aug 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Pharmacology of 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, Care provider
- Enrolment
- 28 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
- NCT05287256
- Sponsor's protocol ID
- IRB00321661
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2022
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic and Pharmacodynamic Effects of Delta-8 and Delta-9 THC
- ClinicalTrials.gov ID
- NCT05287256
- Acronym / sponsor ID
- IRB00321661
- Conditions
- Behavioral Pharmacology of Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 18 Mar 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.
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.
Detailed description
The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 THC in comparison to both placebo and Delta-9 THC. Delta-8 THC is an cannabinoid that has become widely available for retail sale in the US due to a loophole in the 2018 Farm Bill. Delta-8 THC is an isomer of Delta-9 THC, which is the compound responsible for most of the psychoactive effects associated with cannabis. Prior research, while limited, has indicated that Delta-8 THC is less potent but has comparable pharmacodynamic effects to Delta-9 THC, especially at higher doses. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants. The investigators will recruit healthy participants between the ages of 18 and 45 who have prior experience using THC but have not used in at least one month. Two sub-studies will be run, with 5 conditions in each study; sub-study 1 will examine the effects of vaporized Delta-8 THC and sub-study 2 will assess the effects of orally ingested Delta-8 THC. Participants can complete both sub-studies but it is not required. There will be a minimum of 5 outpatient drug administration sessions for each participant, with the option to complete 5 more if interested. The investigators will recruit and consent up to 70 participants in order to obtain 20 completers (up to 40 total individuals) for each sub-study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
- 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 |
|---|---|---|
| Placebo Oral Cannabis | Placebo comparator | Drug: Oral PlaceboSingle acute administration of placebo cannabis baked into a brownie |
| Oral administration of 10mg D-8-THC | Experimental | Drug: Oral Delta-8-THC CannabisSingle acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie |
| Oral administration of 20mg D-8-THC | Experimental | Drug: Oral Delta-8-THC CannabisSingle acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie |
| Oral administration of 40mg D-8-THC | Experimental | Drug: Oral Delta-8-THC CannabisSingle acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie |
| Oral administration of 20mg D-9-THC | Experimental | Drug: Oral Delta-9-THC CannabisSingle acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie |
| Placebo Vaporized Cannabis | Placebo comparator | Drug: Vaporized PlaceboSingle acute administration of placebo cannabis via commercial vaporizer |
| Administration of vaporized 10mg D-8-THC | Experimental | Drug: Vaporized Delta-8-THC CannabisSingle acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer |
| Administration of vaporized 20mg D-8-THC | Experimental | Drug: Vaporized Delta-8-THC CannabisSingle acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer |
| Administration of vaporized 40mg D-8-THC | Experimental | Drug: Vaporized Delta-8-THC CannabisSingle acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer |
| Administration of vaporized 20mg D-9-THC | Experimental | Drug: Vaporized Delta-9-THC CannabisSingle acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Have provided written informed consent
- Be between the ages of 18 and 45
- 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 in urine at the screening visit and again upon admission for each experimental session
- Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
Key exclusion criteria (11 listed)
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
- History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
- Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
- Use of any hemp, cannabis or cannabinoid product in the past 3 months.
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 |
|---|---|---|
| Oral Delta-8-THC CannabisAlso: marijuanaDelta-8-THC cannabis will be orally self-administered by study participants | Drug | Oral administration of 10mg D-8-THC, Oral administration of 20mg D-8-THC, Oral administration of 40mg D-8-THC |
| Oral Delta-9-THC CannabisAlso: marijuanaDelta-9-THC cannabis will be orally self-administered by study participants | Drug | Oral administration of 20mg D-9-THC |
| Oral PlaceboPlacebo will be orally self-administered by study participants | Drug | Placebo Oral Cannabis |
| Vaporized Delta-8-THC CannabisAlso: marijuanaDelta-8-THC cannabis will be self-administered by study participants using a vaporizer | Drug | Administration of vaporized 10mg D-8-THC, Administration of vaporized 20mg D-8-THC, Administration of vaporized 40mg D-8-THC |
| Vaporized Delta-9-THC CannabisAlso: marijuanaDelta-9-THC cannabis will be self-administered by study participants using a vaporizer | Drug | Administration of vaporized 20mg D-9-THC |
| Vaporized PlaceboPlacebo will be self-administered by study participants using a vaporizer | Drug | Placebo Vaporized Cannabis |
Primary outcome
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Time frame: Within 8 hours
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.
7 secondary outcomes
Behavioral task performance as assessed by the DRUID app
Time frame: Within 8 hours
Quantitative levels of D-9-THC in blood
Time frame: Within 8 hours
Quantitative levels of D-8-THC in blood
Time frame: Within 8 hours
Paced Auditory Serial Addition Task (PASAT) score
Time frame: Within 8 hours
Digit Symbol Substitution Task (DSST) score
Time frame: Within 8 hours
Divided Attention as assessed by the DAT
Time frame: Within 8 hours
Heart rate
Time frame: Within 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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Behavioral Pharmacology of Cannabis
Not yet recruitingPhase 1
Behavioral Pharmacology of THC and Beta-Myrcene
Cannabis Use
RecruitingPhase 2
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
THC, Cannabis
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 Oral Delta-8-THC Cannabis, Oral Delta-9-THC Cannabis and Vaporized Delta-8-THC Cannabis in people with Behavioral Pharmacology of 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 10 inclusion and 11 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 17 Feb 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?
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) (time frame: Within 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 17 Feb 2026.