D-limonene and THC PharmacodynamicsPhase 1NCT03609853
Behavioral Pharmacology of THC and D-limonene
A Phase 1 study testing Vaporized THC, limonene, or THC and limonene in people with D-limonene and THC Pharmacodynamics, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- D-limonene and THC Pharmacodynamics
- What is being tested?
- Vaporized THC, limonene, or THC and limonene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 25 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have provided written informed consent
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
- Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
- 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 18 to 36 kg/m2
Show all 9Show fewer
- 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
- Have no allergies to any of the ingredients used to prepare vapor (THC, d-limonene).
- Report having experienced anxiety after consuming cannabis in the past.
Who cannot join
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
- History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) 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, 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.
- Use of dronabinol (Marinol®) within the past month.
- Average use of cannabis more than 2 times per week in the prior 3 months.
Show all 11Show fewer
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Abnormal EKG result that in the investigator's opinion is clinically significant.
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Having previously sought medical attention to manage adverse effects following acute cannabis use.
- Individuals with anemia or who have donated blood in the prior 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation.
Read the detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, limonene alone, THC and limonene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and d-limonene, two common constituents found in cannabis.
- Conditions
- D-limonene and THC Pharmacodynamics
- Being tested
- Placebo, Vaporized THC, limonene, or THC and limonene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo vapor (distilled water)
Vaporized THC, limonene, or THC and limoneneDrug
Acute drug exposure
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (5mL distilled water) Receives: Drug: Placebo |
| Vaporized low THC | Experimental | 15mg of pure THC Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| Vaporized high THC | Experimental | 30mg of pure THC Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| Vaporized low d-limonene | Experimental | 1mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| Vaporized high d-limonene | Experimental | 5mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| Low THC and low d-limonene | Experimental | 15mg of THC paired with 1mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| High THC and low d-limonene | Experimental | 30mg of THC paired with 1mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| Low THC and high d-limonene | Experimental | 15mg of THC paired with 5mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| High THC and high d-limonene | Experimental | 30mg of THC paired with 5mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
| High THC and 15mg d-limonene | Experimental | 30mg of THC paired with 15mg of d-limonene Receives: Drug: Vaporized THC, limonene, or THC and limonene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Change From Baseline Anxiety as Assessed by the Drug Effect Questionnaire (DEQ)
Peak rating (0-100) of Anxiety on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No anxiety and 100 being maximum anxiety
Measured: 0-6 hours
Secondary outcomes (3)
Mean Peak Change From Baseline Paranoid as Assessed by the Drug Effect Questionnaire (DEQ)
Peak change from baseline rating of Paranoid on the DEQ, a 100pt VAS scale with 0 being no paranoia and 100 being extreme paranoia
Measured: 0-6 hours
Mean Peak Change From Baseline Subjective "Heart Racing" as Assessed by the Drug Effect Questionnaire (DEQ)
Mean peak change from baseline for subjective heart racing on the DEQ, a 0-100 VAS scale with 0 being no feeling of heart racing and 100 being an extreme feeling of heart racing.
Measured: 0-6 hours
Mean Peak Change From Baseline Heart Rate
Peak change from baseline in Heart Rate (bpm) measured in seated position by automated monitor
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Apr 2019
- Primary completion28 Jun 2022
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for D-limonene and THC PharmacodynamicsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
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
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609853
- Sponsor's protocol ID
- IRB00085652
- Other IDs
- R01DA043475
- Status last verified
- Dec 2023
- First submitted
- 11 Jul 2018
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Pharmacology of THC and D-limonene
- ClinicalTrials.gov ID
- NCT03609853
- Acronym / sponsor ID
- IRB00085652
- Conditions
- D-limonene and THC Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 18 Oct 2023
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 pharmacokinetics and pharmacodynamics of vaporized d-limonene and THC administered via inhalation.
Detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC alone, limonene alone, THC and limonene together, or placebo. Subjective drug effects and vital signs will be assessed following drug administration. Each participant will receive all 9 dose conditions in a randomized order using a placebo controlled within-subject crossover design. The study will help us understand the individual and interactive effects of THC and d-limonene, two common constituents found in cannabis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (5mL distilled water) |
| Vaporized low THC | Experimental | Drug: Vaporized THC, limonene, or THC and limonene15mg of pure THC |
| Vaporized high THC | Experimental | Drug: Vaporized THC, limonene, or THC and limonene30mg of pure THC |
| Vaporized low d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene1mg of d-limonene |
| Vaporized high d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene5mg of d-limonene |
| Low THC and low d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene15mg of THC paired with 1mg of d-limonene |
| High THC and low d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene30mg of THC paired with 1mg of d-limonene |
| Low THC and high d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene15mg of THC paired with 5mg of d-limonene |
| High THC and high d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene30mg of THC paired with 5mg of d-limonene |
| High THC and 15mg d-limonene | Experimental | Drug: Vaporized THC, limonene, or THC and limonene30mg of THC paired with 15mg of d-limonene |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Have provided written informed consent
- Be between the ages of 18 and 55
- Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
- Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
- 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 (11 listed)
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
- History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) 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, 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.
- Use of dronabinol (Marinol®) within the past month.
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 |
|---|---|---|
| PlaceboPlacebo vapor (distilled water) | Drug | Placebo |
| Vaporized THC, limonene, or THC and limoneneAcute drug exposure | Drug | High THC and 15mg d-limonene, High THC and high d-limonene, High THC and low d-limonene, Low THC and high d-limonene, Low THC and low d-limonene, Vaporized high THC, Vaporized high d-limonene, Vaporized low THC, Vaporized low d-limonene |
Primary outcome
Mean Peak Change From Baseline Anxiety as Assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 0-6 hours
Peak rating (0-100) of Anxiety on the DEQ, a visual analog scale (VAS) self-report questionnaire with 0 being No anxiety and 100 being maximum anxiety
3 secondary outcomes
Mean Peak Change From Baseline Paranoid as Assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 0-6 hours
Mean Peak Change From Baseline Subjective "Heart Racing" as Assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 0-6 hours
Mean Peak Change From Baseline Heart Rate
Time frame: 0-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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 Vaporized THC, limonene, or THC and limonene in people with D-limonene and THC Pharmacodynamics, 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 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 11 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Peak Change From Baseline Anxiety as Assessed by the Drug Effect Questionnaire (DEQ) (time frame: 0-6 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 11 Dec 2023.