Healthy VolunteersPhase 1NCT03832816
Behavioral and Physiological Effects of THC and CBD
A Phase 1 study testing Vaporized THC alone, Vaporized CBD alone and Vaporized CBD with THC in people with Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vaporized THC alone, Vaporized CBD alone and Vaporized CBD with THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2019to Dec 2021
- 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 50 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 50
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Willingness to provide urine sample at the screening visit and again upon admission for the experimental session
- Test negative for recent drug or alcohol use at the screening visit and upon arrival for each experimental session.
- Not be pregnant or nursing (if female). All females must have a negative pregnancy test at the screening visit and at clinic admission.
Show all 10Show fewer
- BMI 18-36
- 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
- Occasional/Intermittent cannabis users.
- Have not donated blood in the prior 30 days.
Who cannot join
- Recent non-medical use of psychoactive drugs;
- History of or current evidence of significant medical or psychiatric illness
- any condition (as determined by the study physician or investigator) that puts the participant at greater risk.
- Recent use of an over the counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Recent use of a prescription medication (with the exception of hormonal birth control prescriptions) 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.
- Recent use of hemp seeds or hemp oil.
Show all 15Show fewer
- Recent use of dronabinol (Marinol).
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Recently enrolled in another clinical trial or have recently received any drug as part of a research study.
- 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
- 5th grade reading level or lower.
- Clinically relevant anxiety.
- Individuals who are night shift workers
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: Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.
Read the detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of 8 possible acute drug administration sessions in which participants will administer THC alone, CBD alone, THC and CBD together, or placebo. Following drug administration, participants will complete a performance session and complete a battery of questionnaires assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone levels will also be assessed before and after drug administration. The study will help the investigators understand the individual and interactive effects of THC and CBD, the two most common cannabis constituents.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, Vaporized THC alone, Vaporized CBD alone, Vaporized CBD with THC
- Keywords
- cortisol, ACTH, Heart rate, delta9-Tetrahydrocannabinol, cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called distilled water
Placebo vapor (distilled water)
Vaporized THC aloneDrug
Acute exposure to vaporized THC
Vaporized CBD aloneDrug
Acute exposure to vaporized CBD
Vaporized CBD with THCDrug
Acute exposure to vaporized CBD with THC
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Distilled Water Receives: Drug: Placebo |
| Vaporized THC alone | Experimental | 5mg pure THC Receives: Drug: Vaporized THC alone |
| Vaporized low CBD alone | Experimental | 50mg pure CBD Receives: Drug: Vaporized CBD alone |
| Vaporized medium CBD alone | Experimental | 100mg pure CBD Receives: Drug: Vaporized CBD alone |
| Vaporized high CBD alone | Experimental | 200mg pure CBD Receives: Drug: Vaporized CBD alone |
| Vaporized low CBD with THC | Experimental | 50mg pure CBD paired with 5mg THC Receives: Drug: Vaporized CBD with THC |
| Vaporized medium CBD with THC | Experimental | 100mg pure CBD paired with 5mg THC Receives: Drug: Vaporized CBD with THC |
| Vaporized high CBD with THC | Experimental | 200mg pure CBD paired with 5mg THC Receives: Drug: Vaporized CBD with THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood cortisol levels
Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in blood Adrenocorticotropic hormone (ACTH) levels
Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in heart rate
Peak change in rate (in beats per minute)
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)
Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in Mood state as assessed by the The Profile of Mood States (POMS)
Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Measured: Prior to drug exposure and for 4 hours post-exposure.
Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Measured: Prior to drug exposure and for 4 hours post-exposure.
Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire
Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Prior to drug exposure and for 4 hours post-exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: cancellation of funding contract
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Weerts, PhD, Principal investigator, Johns Hopkins UniversityRyan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832816
- Sponsor's protocol ID
- IRB00199386
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Physiological Effects of delta9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD)
- ClinicalTrials.gov ID
- NCT03832816
- Acronym / sponsor ID
- IRB00199386
- Conditions
- Healthy Volunteers
- Keywords
- cortisol, ACTH, Heart rate, delta9-Tetrahydrocannabinol, cannabidiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: cancellation of funding contract
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Feb 2019 (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 physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.
Detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of 8 possible acute drug administration sessions in which participants will administer THC alone, CBD alone, THC and CBD together, or placebo. Following drug administration, participants will complete a performance session and complete a battery of questionnaires assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone levels will also be assessed before and after drug administration. The study will help the investigators understand the individual and interactive effects of THC and CBD, the two most common cannabis constituents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDistilled Water |
| Vaporized THC alone | Experimental | Drug: Vaporized THC alone5mg pure THC |
| Vaporized low CBD alone | Experimental | Drug: Vaporized CBD alone50mg pure CBD |
| Vaporized medium CBD alone | Experimental | Drug: Vaporized CBD alone100mg pure CBD |
| Vaporized high CBD alone | Experimental | Drug: Vaporized CBD alone200mg pure CBD |
| Vaporized low CBD with THC | Experimental | Drug: Vaporized CBD with THC50mg pure CBD paired with 5mg THC |
| Vaporized medium CBD with THC | Experimental | Drug: Vaporized CBD with THC100mg pure CBD paired with 5mg THC |
| Vaporized high CBD with THC | Experimental | Drug: Vaporized CBD with THC200mg pure CBD paired with 5mg THC |
Who may qualify
- Ages
- 18 to 50 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 50
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Willingness to provide urine sample at the screening visit and again upon admission for the experimental session
- Test negative for recent drug or alcohol use at the screening visit and upon arrival for each experimental session.
Key exclusion criteria (15 listed)
- Recent non-medical use of psychoactive drugs;
- History of or current evidence of significant medical or psychiatric illness
- any condition (as determined by the study physician or investigator) that puts the participant at greater risk.
- Recent use of an over the counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Recent use of a prescription medication (with the exception of hormonal birth control prescriptions) 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.
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 |
|---|---|---|
| PlaceboAlso: distilled waterPlacebo vapor (distilled water) | Drug | Placebo |
| Vaporized THC aloneAcute exposure to vaporized THC | Drug | Vaporized THC alone |
| Vaporized CBD aloneAcute exposure to vaporized CBD | Drug | Vaporized high CBD alone, Vaporized low CBD alone, Vaporized medium CBD alone |
| Vaporized CBD with THCAcute exposure to vaporized CBD with THC | Drug | Vaporized high CBD with THC, Vaporized low CBD with THC, Vaporized medium CBD with THC |
Primary outcome
Change in blood cortisol levels
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured
Change in blood Adrenocorticotropic hormone (ACTH) levels
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured
Change in heart rate
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in rate (in beats per minute)
Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).
Change in Mood state as assessed by the The Profile of Mood States (POMS)
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).
Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire
Time frame: Prior to drug exposure and for 4 hours post-exposure.
Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
Related trials for Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
Elise Weerts, PhD principal investigator
Johns Hopkins University
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 alone, Vaporized CBD alone and Vaporized CBD with THC in people with Healthy Volunteers, 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 15 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: withdrawn, as of the sponsor's last update on 5 Aug 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in blood cortisol levels (time frame: Prior to drug exposure and for 4 hours post-exposure.). The study lists 8 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 5 Aug 2019.