HealthyEarly Phase 1NCT01180374
The Effects of Cannabidiol and ∆-9-THC in Humans
A Early Phase 1 study testing Cannabidiol and Delta-9-THC in people with Healthy, run by Yale University at 1 site in United States.
Trial summary
Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabidiol and Delta-9-THC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2010to 6 Oct 2014
- 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
- Exposed to Cannabis at least once in lifetime
Who cannot join
- Cannabis Naive
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.
- Conditions
- Healthy
- Being tested
- Cannabidiol, Delta-9-THC, Placebo
- Keywords
- Cannabis, Marijuana, Cannabidiol, CBD, THC, Psychotic Disorders
- Medical subject headings
- Marijuana Abuse, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Active Cannabidiol 5mg.
Delta-9-THCDrug
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
PlaceboDrug
Placebo (about a quarter spoon of alcohol with no CBD).
PlaceboDrug
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active Canabidiol and Active Delta-9-THC | Experimental | Not described Receives: Drug: Cannabidiol; Drug: Delta-9-THC |
| Placebo and Active Delta-9-THC | Placebo comparator | Not described Receives: Drug: Delta-9-THC; Drug: Placebo |
| Active Cannabidiol and Placebo | Experimental | Not described Receives: Drug: Cannabidiol; Drug: Placebo |
| Placebo and Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Measures
Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery.
Measured: Baseline, +15, +80, +240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study start1 Feb 2010
- Primary completion6 Oct 2014
- Study completion6 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Yale 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, M.D, Principal investigator, Yale University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180374
- Sponsor's protocol ID
- 1001006240
- Status last verified
- Jan 2022
- First submitted
- 10 Aug 2010
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ganesh S, Cortes-Briones J, Schnakenberg Martin AM, Skosnik PD, D'Souza DC, Ranganathan M. Delta-9-Tetrahydrocannabinol, Cannabidiol, and Acute Psychotomimetic States: A Balancing Act of the Principal Phyto-Cannabinoids on Human Brain and Behavior. Cannabis Cannabinoid Res. 2023 Oct;8(5):846-856. doi: 10.1089/can.2021.0166. Epub 2022 Mar 18.
PubMed 35319274
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
- ClinicalTrials.gov ID
- NCT01180374
- Acronym / sponsor ID
- 1001006240
- Conditions
- Healthy
- Keywords
- Cannabis, Marijuana, Cannabidiol, CBD, THC, Psychotic Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 6 Oct 2014 (actual)
- Study completion
- 6 Oct 2014 (actual)
- First posted
- 12 Aug 2010 (estimated)
- 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 is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Canabidiol and Active Delta-9-THC | Experimental | Drug: Cannabidiol, Drug: Delta-9-THC |
| Placebo and Active Delta-9-THC | Placebo comparator | Drug: Delta-9-THC, Drug: Placebo |
| Active Cannabidiol and Placebo | Experimental | Drug: Cannabidiol, Drug: Placebo |
| Placebo and Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Exposed to Cannabis at least once in lifetime
Key exclusion criteria (1 listed)
- Cannabis Naive
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 |
|---|---|---|
| CannabidiolActive Cannabidiol 5mg. | Drug | Active Canabidiol and Active Delta-9-THC, Active Cannabidiol and Placebo |
| Delta-9-THCActive Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint". | Drug | Active Canabidiol and Active Delta-9-THC, Placebo and Active Delta-9-THC |
| PlaceboPlacebo (about a quarter spoon of alcohol with no CBD). | Drug | Placebo and Active Delta-9-THC, Placebo and Placebo |
| PlaceboPlacebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes. | Drug | Active Cannabidiol and Placebo, Placebo and Placebo |
Primary outcome
Behavioral Measures
Time frame: Baseline, +15, +80, +240
Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery.
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 31 Jan 2022.
- Derived from this study: PubMed 35319274Ganesh S, Cortes-Briones J, Schnakenberg Martin AM, Skosnik PD, D'Souza DC, Ranganathan M. Delta-9-Tetrahydrocannabinol, Cannabidiol, and Acute Psychotomimetic States: A Balancing Act of the Principal Phyto-Cannabinoids on Human Brain and Behavior. Cannabis Cannabinoid Res. 2023 Oct;8(5):846-856. doi: 10.1089/can.2021.0166. Epub 2022 Mar 18.
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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.
Mohini Ranganathan, M.D principal investigator
Yale University Medical School
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 Cannabidiol and Delta-9-THC in people with Healthy, run by Yale 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 1 inclusion and 1 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 31 Jan 2022. 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?
Behavioral Measures (time frame: Baseline, +15, +80, +240). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180374, which also lists 1 linked publication.
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 31 Jan 2022.