Behavioral Pharmacology of CannabinoidsEarly Phase 1NCT05478863
The Pharmacodynamics of Cannabinoid-Caffeine Combinations
A Early Phase 1 study testing Oral THC, Oral CBD and Oral Caffeine in people with Behavioral Pharmacology of Cannabinoids, run by Johns Hopkins University at 1 site in United States.
Trial summary
Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Pharmacology of Cannabinoids
- What is being tested?
- Oral THC, Oral CBD and Oral Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 2 Oct 2024
- Phase
- Early 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
- Person is between 18 and 55-years-old (inclusive).
- Person has a body mass index (BMI) between 18 and 35 Kg/m^2 (inclusive).
- Person is willing and able to provide informed consent.
- Person has consumed cannabis products containing THC in the past.
- Person has consumed caffeine products in the past.
- If person uses medication that has been deemed acceptable (e.g., not contraindicated) by the Investigator, the person has maintained a stable dose and regimen on existing medications for at least 30 days prior to participation in the study and throughout the study.
- Person agrees to abide by all study restrictions and comply with all study procedures.
Who cannot join
- Person has a known history of significant allergic condition or significant hypersensitivity to cannabis, cannabinoid medications, hemp products, or excipients of the investigational product.
- Person has a known history of significant allergic condition or significant hypersensitivity to caffeine or caffeine products.
- Person has been exposed to any investigational drug or device < 30 days prior to randomization or plans to take an investigational drug during the study.
- Person has used cannabis, cannabinoid analogue (e.g., dronabinol, nabilone), and/or any CBD- or delta-9-tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year.
- Person consumes more than 400 mg/day of coffee or other caffeine products (approximately 4 cups of coffee per day) on average within 30 days of screening.
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- Person has used illicit substances (e.g., amphetamine, cocaine, methamphetamine, 3,4-Methyl enedioxy methamphetamine [MDMA], lysergic acid diethylamide [LSD], ketamine, heroin, psilocybin, salvia, prescription medications not prescribed to the person) within 30 days of screening or during the study.
- Person tests positive for any substance, including THC, at screening.
- Person is currently using products or medications that may interact with one or more of the ingredients in the investigational product, including the following drugs or supplements: warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin [mTOR] inhibitors, oral tacrolimus, St. John's wort, Epidiolex, over the counter stimulants (e.g., phentermine), prescribed stimulants (e.g., Ritalin, Vyvanse), antihypertensive drugs (e.g., captopril, valsartan).
- Person endorses current suicidal intent as indexed via items 4 and 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Person has a history or family history of psychosis or schizophrenia.
- Person has a diagnosis of cardiac disease or significant cardiac condition.
- Person has a diagnosis of hypertension and/or a blood pressure reading with systolic pressure > 150 mm Hg or diastolic pressure > 90 mm Hg.
- Person has an acute or progressive disease or disorder that is likely to interfere with the objectives of the study or the ability to adhere to protocol requirements.
- Person is currently pregnant, breastfeeding, or is planning to become pregnant within 30 days of completing the study.
- Woman of childbearing potential, unless she has not engaged in vaginal intercourse, or she has used effective contraception when doing so (for example, double barrier), for at least 30 days prior to the study (however, a male condom should not be used in conjunction with a female condom).
- Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, double barrier) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
- Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, double barrier) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
- Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 ⋅ upper limit of normal or total bilirubin [TBL] >2 ⋅ upper limit of normal) OR the ALT or aspartate aminotransferase (AST) >3 ⋅ upper limit of normal and TBL >2 ⋅ upper limit of normal (or international normalized ratio [INR] >1.5).
- Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine BPRU
Baltimore, Maryland, 21224
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Within-Subject Crossover Study of the Effects of Combinations of Cannabinoids and Caffeine
Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side effects of caffeine (e.g., feeling jittery) without impacting positive or desired effects. CBD also shows potential in reducing undesirable acute effects (e.g., anxiety) of delta-9-tetrahydrocannabinol (THC), the primary intoxicating cannabinoid found in cannabis. Despite these promising findings, little is known about the potential effects of THC, caffeine, and CBD in combination. This double-blind, randomized, placebo-controlled, within-subject crossover study will assess the effects of combinations of THC, CBD, and caffeine (i.e., THC only; THC + caffeine; THC + CBD + caffeine) on subjective energy, arousal, and cognitive performance.
- Conditions
- Behavioral Pharmacology of Cannabinoids
- Being tested
- Oral Placebo, Oral THC, Oral CBD, Oral Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PlaceboDrug
Placebo will be orally self-administered by study participants.
Oral THCDrug
THC will be orally self-administered by study participants.
Oral CBDDrug
CBD will be orally self-administered by study participants.
Oral CaffeineDrug
Caffeine will be orally self-administered by study participants.
| Study group | Role | What they receive |
|---|---|---|
| Oral placebo | Placebo comparator | Acute administration of oral placebo three times in study session (Time 0, 60, and 120). Receives: Drug: Oral Placebo |
| Oral administration of 2.5 mg THC | Experimental | Acute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120). Receives: Drug: Oral THC |
| Oral administration of 2.5 mg THC + 60 mg caffeine | Experimental | Acute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120). Receives: Drug: Oral THC; Drug: Oral Caffeine |
| Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD | Experimental | Acute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120). Receives: Drug: Oral THC; Drug: Oral CBD; Drug: Oral Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®)
Driving Performance as Measured by the DRiving Under the Influence of Drugs (DRUID®) behavioral task. Higher scores = greater impairment.
Measured: 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
Driving Performance on the Driving Simulator
Driving Performance as Measured by a Driving Simulator task
Measured: 170-minutes post drug administration
Secondary outcomes (5)
Change in subjective feelings of energy
Ratings on the Energetic vs. Lethargic item on the Visual Analogue Mood Scale (VAMS)
Measured: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of alertness
Ratings on the Alertness vs. Drowsy item on the Visual Analogue Mood Scale (VAMS)
Measured: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of focus
Ratings on the Attentive vs. Dreamy item on the Visual Analogue Mood Scale (VAMS)
Measured: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of jitteriness
Ratings on the jitteriness item on the Mood Rating Scale (MRS)
Measured: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of anxiety
Ratings on the state version of the State-Trait Anxiety Inventory (STAI-S)
Measured: 0-, 30-, 90-, 150-minutes post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start20 Jan 2023
- Primary completion2 Oct 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 CannabinoidsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canopy Growth Corporation
- Responsible party
- Sponsor
- Investigators
- Justin Strickland, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478863
- Sponsor's protocol ID
- IRB00330923
- Status last verified
- Oct 2024
- First submitted
- 26 Jul 2022
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Within-Subject Crossover Study of the Effects of Combinations of Cannabinoids and Caffeine
- ClinicalTrials.gov ID
- NCT05478863
- Acronym / sponsor ID
- IRB00330923
- Conditions
- Behavioral Pharmacology of Cannabinoids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canopy Growth Corporation
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 28 Jul 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.
Cannabis and caffeine are two of the most commonly consumed psychoactive substances in the world, with many consumers reporting positive impacts on energy, alertness, and focus. Preliminary evidence has suggested that cannabidiol (CBD), the non-intoxicating cannabinoid found in cannabis, may mitigate the negative side effects of caffeine (e.g., feeling jittery) without impacting positive or desired effects. CBD also shows potential in reducing undesirable acute effects (e.g., anxiety) of delta-9-tetrahydrocannabinol (THC), the primary intoxicating cannabinoid found in cannabis. Despite these promising findings, little is known about the potential effects of THC, caffeine, and CBD in combination. This double-blind, randomized, placebo-controlled, within-subject crossover study will assess the effects of combinations of THC, CBD, and caffeine (i.e., THC only; THC + caffeine; THC + CBD + caffeine) on subjective energy, arousal, and cognitive performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral placebo | Placebo comparator | Drug: Oral PlaceboAcute administration of oral placebo three times in study session (Time 0, 60, and 120). |
| Oral administration of 2.5 mg THC | Experimental | Drug: Oral THCAcute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120). |
| Oral administration of 2.5 mg THC + 60 mg caffeine | Experimental | Drug: Oral THC, Drug: Oral CaffeineAcute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120). |
| Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD | Experimental | Drug: Oral THC, Drug: Oral CBD, Drug: Oral CaffeineAcute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Person is between 18 and 55-years-old (inclusive).
- Person has a body mass index (BMI) between 18 and 35 Kg/m^2 (inclusive).
- Person is willing and able to provide informed consent.
- Person has consumed cannabis products containing THC in the past.
- Person has consumed caffeine products in the past.
Key exclusion criteria (20 listed)
- Person has a known history of significant allergic condition or significant hypersensitivity to cannabis, cannabinoid medications, hemp products, or excipients of the investigational product.
- Person has a known history of significant allergic condition or significant hypersensitivity to caffeine or caffeine products.
- Person has been exposed to any investigational drug or device < 30 days prior to randomization or plans to take an investigational drug during the study.
- Person has used cannabis, cannabinoid analogue (e.g., dronabinol, nabilone), and/or any CBD- or delta-9-tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
- Person has history of use of any synthetic cannabinoid receptor agonist (e.g., spice, K2) within the past year.
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 PlaceboPlacebo will be orally self-administered by study participants. | Drug | Oral placebo |
| Oral THCTHC will be orally self-administered by study participants. | Drug | Oral administration of 2.5 mg THC, Oral administration of 2.5 mg THC + 60 mg caffeine, Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD |
| Oral CBDCBD will be orally self-administered by study participants. | Drug | Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD |
| Oral CaffeineCaffeine will be orally self-administered by study participants. | Drug | Oral administration of 2.5 mg THC + 60 mg caffeine, Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBD |
Primary outcome
Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®)
Time frame: 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration
Driving Performance as Measured by the DRiving Under the Influence of Drugs (DRUID®) behavioral task. Higher scores = greater impairment.
Driving Performance on the Driving Simulator
Time frame: 170-minutes post drug administration
Driving Performance as Measured by a Driving Simulator task
5 secondary outcomes
Change in subjective feelings of energy
Time frame: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of alertness
Time frame: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of focus
Time frame: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of jitteriness
Time frame: 0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of anxiety
Time frame: 0-, 30-, 90-, 150-minutes post drug administration
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 8 Oct 2024.
- 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.
Justin Strickland, Ph.D. 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 Early Phase 1 study testing Oral THC, Oral CBD and Oral Caffeine in people with Behavioral Pharmacology of Cannabinoids, 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 7 inclusion and 20 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 8 Oct 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®) (time frame: 0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration). The study lists 2 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 8 Oct 2024.