Acute Cannabinoid IntoxicationPhase 2NCT05282797
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test
A Phase 2 study testing ANEB-001 in people with Acute Cannabinoid Intoxication, run by Anebulo Pharmaceuticals at 1 site in Netherlands.
Trial summary
The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Cannabinoid Intoxication
- What is being tested?
- ANEB-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2021to 26 Aug 2023
- Phase
- Phase 2
- 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
- Signed informed consent prior to any study-mandated procedure
- BMI between 18 and 30 kg/m2
- Minimum weight 50 kg
- Occasional cannabis user
Who cannot join
- Evidence of active or chronic condition that could interfere with, or which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
- Clinically significant abnormalities, as judged by the investigator
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody at screening
- Systolic blood pressure greater than 130 or less than 90 mm Hg and diastolic blood pressure greater than 95 or less than 50 mm Hg at screening Abnormal findings in the resting electrocardiogram
- Use of any medications within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol and ibuprofen and topical medications.
- Use of any vitamin, mineral, herbal and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer)
Show all 13Show fewer
- Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study)
- History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquilizers, or any other addictive agent other than recreative use of THC
- Positive test for drugs of abuse (other than THC) at screening.
- Positive test for drugs of abuse pre-dose
- Clinically significant suicidal ideation in the past 5 years as judged by the investigator or any life-time suicide attempts
- History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.
- History of a clinically significant mood disorder, including but not limited to major depressive disorder, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centre for Human Drug Research (CHDR)
Leiden, South Holland, 2333
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of CB1 Antagonist ANEB-001 in Healthy Occasional Cannabis Users in a THC Challenge Test.
The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for acute cannabinoid intoxication.
Read the detailed description
This study will evaluate whether ANEB-001 effectively inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC). All cohorts in part A and B of the study will be randomized, double-blind and placebo-controlled. Randomization is deemed appropriate to avoid selection bias for active compound or placebo treatment. A double-blind and placebo-controlled design is deemed appropriate because of the safety, tolerability and pharmacodynamic assessments that will be performed in this study. By double-blinding the study, bias arising from study subject's or investigator's knowledge about treatment assignment is avoided. Part C does not include a placebo group and will therefore not be blinded.
- Conditions
- Acute Cannabinoid Intoxication
- Being tested
- ANEB-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANEB-001Drug
Experimental Treatment
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Part A - ANEB-001 | Experimental | Subjects receive THC and varying amounts of ANEB-001 Receives: Drug: ANEB-001 |
| Part A - Placebo | Placebo comparator | Subjects receive THC and placebo Receives: Drug: Placebo |
| Part B - Cohort 1 - ANEB-001 | Experimental | Subjects receive 21 mg of THC and 30 mg of ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 1 - Placebo | Placebo comparator | Subjects receive 21 mg of THC and placebo Receives: Drug: Placebo |
| Part B - Cohort 2 - ANEB-001 | Experimental | Subjects receive 21 mg of THC and 10 mg of ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 2 - Placebo | Placebo comparator | Subjects receive 21 mg of THC and placebo Receives: Drug: Placebo |
| Part B - Cohort 3 - ANEB-001 | Experimental | Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 3 - Placebo | Placebo comparator | Subjects receive 21 mg THC and 1 hour later, placebo Receives: Drug: Placebo |
| Part B - Cohort 4 - ANEB-001 | Experimental | Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 4 - Placebo | Placebo comparator | Subjects receive 40 mg of THC and 1 hour later, placebo Receives: Drug: Placebo |
| Part B - Cohort 5 - ANEB-001 | Experimental | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 5 - Placebo | Placebo comparator | Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 Receives: Drug: Placebo |
| Part B - Cohort 6 - ANEB-001 | Experimental | Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, 10 mg of ANEB-001 Receives: Drug: ANEB-001 |
| Part B - Cohort 6 - Placebo | Placebo comparator | Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo Receives: Drug: Placebo |
| Part C - Cohort 7 - ANEB-001 | Experimental | Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001 Receives: Drug: ANEB-001 |
| Part C - Cohort 8 - ANEB-001 | Experimental | Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001 Receives: Drug: ANEB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Feeling High
Feeling High on a visual analog scale (mm)
Measured: Day 1
Postural stability
Body sway (mm);
Measured: Day 1
Subjective Alertness
Alertness on a visual analog scale (mm)
Measured: Day 1
Heart Rate
Heart Rate in beats/min
Measured: Day 1
Secondary outcomes (10)
Subjective Mood
Mood on a visual analog scale (mm)
Measured: Day 1
Subjective Calmness
Calmness on a visual analog scale (mm)
Measured: Day 1
Feeling of Drug Effect
Feeling of drug effect on a visual analog scale (mm)
Measured: Day 1
Symbol Digit Substitution Test (SDST)
Part C Only
Measured: Day 1
Visual Verbal Learning Test (VVLT)
Part C Only
Measured: Day 1
Timed Up-and-Go test (TUG)
Part C Only
Measured: Day 1
Alternate Finger Tapping (AFT)
Part C Only
Measured: Day 1
Basic Symptom Inventory (BSI)
Part C Only
Measured: Day 1
Brief Psychiatric Rating Scale (BPRS)
Part C Only
Measured: Day 1
Clinical Global Impression of Severity (CGIS)
Part C Only
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Dec 2021
- Primary completion26 Aug 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cannabinoid IntoxicationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anebulo Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GJ Groeneveld, MD, PhD, Principal investigator, CHDR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282797
- Sponsor's protocol ID
- AN01AC11
- Status last verified
- Aug 2023
- First submitted
- 8 Mar 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of CB1 Antagonist ANEB-001 in Healthy Occasional Cannabis Users in a THC Challenge Test.
- ClinicalTrials.gov ID
- NCT05282797
- Acronym / sponsor ID
- AN01AC11
- Conditions
- Acute Cannabinoid Intoxication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Anebulo PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 26 Aug 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 16 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 aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for acute cannabinoid intoxication.
Detailed description
This study will evaluate whether ANEB-001 effectively inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC). All cohorts in part A and B of the study will be randomized, double-blind and placebo-controlled. Randomization is deemed appropriate to avoid selection bias for active compound or placebo treatment. A double-blind and placebo-controlled design is deemed appropriate because of the safety, tolerability and pharmacodynamic assessments that will be performed in this study. By double-blinding the study, bias arising from study subject's or investigator's knowledge about treatment assignment is avoided. Part C does not include a placebo group and will therefore not be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Part A - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive THC and varying amounts of ANEB-001 |
| Part A - Placebo | Placebo comparator | Drug: PlaceboSubjects receive THC and placebo |
| Part B - Cohort 1 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive 21 mg of THC and 30 mg of ANEB-001 |
| Part B - Cohort 1 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive 21 mg of THC and placebo |
| Part B - Cohort 2 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive 21 mg of THC and 10 mg of ANEB-001 |
| Part B - Cohort 2 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive 21 mg of THC and placebo |
| Part B - Cohort 3 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive 21 mg of THC and 1 hour later, 30 mg ANEB-001 |
| Part B - Cohort 3 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive 21 mg THC and 1 hour later, placebo |
| Part B - Cohort 4 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive 40 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 4 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive 40 mg of THC and 1 hour later, placebo |
| Part B - Cohort 5 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 5 - Placebo | Placebo comparator | Drug: PlaceboSubjects receive 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 6 - ANEB-001 | Experimental | Drug: ANEB-001Subjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, 10 mg of ANEB-001 |
| Part B - Cohort 6 - Placebo | Placebo comparator | Drug: PlaceboSubjects will consume a high fat meal prior to receiving 30 mg of THC and 1 hour later, placebo |
| Part C - Cohort 7 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive a 40 mg dose of THC and a 10 mg dose of ANEB-001 |
| Part C - Cohort 8 - ANEB-001 | Experimental | Drug: ANEB-001Subjects receive a 60 mg dose of THC and a 20 mg dose of ANEB-001 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent prior to any study-mandated procedure
- BMI between 18 and 30 kg/m2
- Minimum weight 50 kg
- Occasional cannabis user
Key exclusion criteria (13 listed)
- Evidence of active or chronic condition that could interfere with, or which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
- Clinically significant abnormalities, as judged by the investigator
- Positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody at screening
- Systolic blood pressure greater than 130 or less than 90 mm Hg and diastolic blood pressure greater than 95 or less than 50 mm Hg at screening Abnormal findings in the resting electrocardiogram
- Use of any medications within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol and ibuprofen and topical medications.
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 |
|---|---|---|
| ANEB-001Experimental Treatment | Drug | Part A - ANEB-001, Part B - Cohort 1 - ANEB-001, Part B - Cohort 2 - ANEB-001, Part B - Cohort 3 - ANEB-001, Part B - Cohort 4 - ANEB-001, Part B - Cohort 5 - ANEB-001, Part B - Cohort 6 - ANEB-001, Part C - Cohort 7 - ANEB-001, Part C - Cohort 8 - ANEB-001 |
| PlaceboPlacebo comparator | Drug | Part A - Placebo, Part B - Cohort 1 - Placebo, Part B - Cohort 2 - Placebo, Part B - Cohort 3 - Placebo, Part B - Cohort 4 - Placebo, Part B - Cohort 5 - Placebo, Part B - Cohort 6 - Placebo |
Primary outcome
Subjective Feeling High
Time frame: Day 1
Feeling High on a visual analog scale (mm)
Postural stability
Time frame: Day 1
Body sway (mm);
Subjective Alertness
Time frame: Day 1
Alertness on a visual analog scale (mm)
Heart Rate
Time frame: Day 1
Heart Rate in beats/min
10 secondary outcomes
Subjective Mood
Time frame: Day 1
Subjective Calmness
Time frame: Day 1
Feeling of Drug Effect
Time frame: Day 1
Symbol Digit Substitution Test (SDST)
Time frame: Day 1
Visual Verbal Learning Test (VVLT)
Time frame: Day 1
Timed Up-and-Go test (TUG)
Time frame: Day 1
Alternate Finger Tapping (AFT)
Time frame: Day 1
Basic Symptom Inventory (BSI)
Time frame: Day 1
Brief Psychiatric Rating Scale (BPRS)
Time frame: Day 1
Clinical Global Impression of Severity (CGIS)
Time frame: Day 1
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 29 Aug 2023.
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.
GJ Groeneveld, MD, PhD principal investigator
CHDR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANEB-001 in people with Acute Cannabinoid Intoxication, run by Anebulo Pharmaceuticals at 1 site in Netherlands.
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 4 inclusion and 13 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 29 Aug 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 Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Subjective Feeling High (time frame: Day 1). The study lists 4 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 29 Aug 2023.