Cannabis AbusePhase 1DDINCT06395688
Drug-Drug Interaction Between THC and AEF0117
A Phase 1 study testing 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in people with Cannabis Abuse, run by Aelis Farma.
Trial summary
This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence. The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Abuse
- What is being tested?
- 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2026
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females of any race, 21 to 55 years old, both inclusive.
- Subjects must use highly effective contraception.
- Participants who engage in heterosexual sex must use highly effective contraception during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Female participants who are heterosexually active are eligible if: they use highly effective contraception or are post-menopausal and with a negative pregnancy test. Use of hormonal contraception must have been stable for 3 months prior to screening and expected to be unchanged during the trial.
- Body mass index (BMI) between 20.0 and ≤35.0 kg/m2 at screening.
- Be informed of the nature of the trial and provide written informed consent.
- Be legally competent and able to communicate effectively (in English) with trial personnel.
- Cannabis smoker (use ≥1 day the last 2 months and ≤2 days/week) who agrees to abstain from cannabis (except for what is provided by investigators) for 3 days prior to and including Day 1 and Day 8 of the study, and while in the clinic.
Who cannot join
- Severe learning disability, brain damage, or pervasive developmental disorder.
- Any disease or condition that according to the investigator's medical judgment might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- Any clinical laboratory values assessed as clinically significant by the investigator.
- a) A history of alcohol- or substance use disorders within the past 2 years, recent or current regular use of any illicit drugs except cannabis. In case of a positive drug screen (except for cannabis) at screening, a negative test is required at re-screening.
- The alcohol breath test and urine drug screen at predose Day 1 must be negative (including for cannabis, a level of THC-COOH <100 ng/mL is allowed).
- A history of or current serious mental illness including active or recent suicidal ideation, severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder), and/or an abnormal Columbia-Suicide Severity Rating Scale (C-SSRS) result (i.e., a C-SSRS score of ≥3).
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- History of COVID-19 within 4 weeks prior to Day 1, or positive COVID 19 test if required according to standard procedures at the site.
- A history of difficulty donating blood or inadequate venous access.
- Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant by the investigator.
- A corrected QT interval (Fridericia's correction, QTcF) >450 msec for males and >470 msec for females.
- Clinically significant anemia or low hemoglobin (levels <9 g/dL) at screening, donation of >250 mL of blood or plasma or received any blood and plasma for medical/surgical reasons within the 30 days prior to receiving trial drug, or intention to donate blood or plasma within 1 month after receiving trial drug.
- Allergies to the trial drug and known allergies to corn or corn derivatives.
- Use of any prescription or over-the-counter drug therapy, including psychoactive and/or psychotropic medication, herbal or homeopathic supplements unapproved by the sponsor within 2 weeks prior to receiving the trial drug (for drugs with an elimination half-life greater than 10 days, this will be extended to 60 days).
- Use of bodybuilding supplements, any food supplement or topical product containing pregnenolone, or any other steroid, including phytosteroids.
- Use of a diet or supplements (e.g., St. John's Wort), or food and fruit juices (e.g., grapefruit juice, Sevilla oranges) known to induce or inhibit hepatic drug metabolism within 2 weeks prior to receiving the trial drug and until the follow-up visit, unless approved by the sponsor's medical monitor.
- Tobacco smokers who smoke more than 5 cigarettes per day or use an equivalent daily amount of other tobacco products and are not willing to abstain from tobacco smoking during the inpatient visits.
- Legal status that would interfere with participation.
- Unable to follow the restrictions outlined in the protocol.
- Use of an investigational drug or product, or participation in a drug trial within the last 90 days prior to receiving the trial drug.
- Participation in a previous trial with AEF0117 within the last 3 months prior to screening.
About this study
Official title: A Double Blind, Placebo-controlled Trial in Healthy Volunteers to Investigate the Effect of Multiple Oral Doses of AEF0117 Versus Placebo on the Pharmacokinetics of THC and Its Metabolites 11 OH THC and THC COOH When Smoking Cannabis.
This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence.
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.
Read the detailed description
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.
Participants will be male or female in good health aged from 21y to 55y old and who are recreational cannabis users.
The participant will receive either AEF0117 (2 mg) or placebo. The sponsor team, the research staff and the participant won't know which study medication has been given.
The main objectives of the trial are:
- To compare the effect of AEF0117 multiple doses on the maximal plasma concentration and other pharmacokinetic parameters of the THC and its metabolites.
- To investigate safety and tolerability of multiple doses of AEF0117 and when co-administered with a dose of smoked cannabis.
The participant will come for 2 inpatient phases (including one overnight stay). Those 2 inpatient phases are separated by 5 days at home.
After a screening period assessing the good health and the eligibility of the participant, on day 1 they will receive 2 capsules of the study medication and will smoke one cannabis cigarette. During the day, blood samples will be collected at defined timepoints before the study medication, after the study medication and before smoking and after smoking.
On day 2, Blood samples will be collected before and after the study medication intake.
At the end of the assessements, the participant will be discharged. They could be requested to stay at the research facility if they experience any adverse effects From Day 3 to Day 7, the participant will be contacted by phone or by videoconference to confirm the study medication intake and if they experience any adverse events.
On day 8, the participant will come back to the research facility for a 2 days visit including an overnight stay. Assessments and procedures will similar to those performed on Day 1 and Day 2.
On Day 14, the participant will come back to the research facility a last time for a final blood collection.
- Conditions
- Cannabis Abuse
- Being tested
- 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one, Placebo
- Keywords
- Cannabis use disorder
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3ß-(4-methoxybenzyloxy)pregn-5-en-20-oneDrug
Also called AEF0117
AEF0117 soft capsules of 1mg
PlaceboDrug
Placebo soft capsules (identical to active compound)
| Study group | Role | What they receive |
|---|---|---|
| AEF0117 | Experimental | Participant will be administered once daily 2 placebo capsules for 1 day and 2 AEF0117 capsules for 7days Receives: Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one; Drug: Placebo |
| Placebo | Placebo comparator | Participant will be administered once daily 2 placebo capsules for 8 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for co-administration of THC and AEF0117
Comparison of the maximal plasma concentration (Cmax) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo.
Measured: Day1, Day8
Secondary outcomes (12)
AUC for co-administration of THC and AEF0117
Comparison of the area under the curve (AUC) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo.
Measured: Day1, Day8
Tmax for co-administration of THC and AEF0117
Comparison of time of peak concentration of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Tlag for co-administration of THC and AEF0117
Comparison of Tlag of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Clast for co-administration of THC and AEF0117
Comparison of Clast of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
t1/2 for co-administration of THC and AEF0117
Comparison of plasma half-life (t1/2) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Cmax for 11-OH-THC and THC-COOH
Comparison of peak concentration (Cmax) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
AUC for 11-OH-THC and THC-COOH
Comparison of the area under the curve (AUC) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Tmax for 11-OH-THC and THC-COOH
Comparison of the time of peak concentration (Tmax) of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Tlag for 11-OH-THC and THC-COOH
Comparison of Tlag of 11-OH-THC and THC-COOH after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Incidence of TEAEs or TESAEs
Assessed by AE and SAE reporting
Measured: From Day1 to Day14
Incidence of TEAEs and TESAEs assessed by vital signs
By evaluating changes from the baseline in vital signs
Measured: Day1, Day2, Day8, Day9, Day14
Effect on heart rate
Measurement of Heart rate over predefined time intervals from prior to IMP dosing until 11 hours after dosing during co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo
Measured: Day1, Day8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Due to several issues, this study has never been submitted to the IRB. So the sponsor was decided to withdraw it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis AbuseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aelis Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Margaret Haney, PhD, Principal investigator, New York Institute Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395688
- Sponsor's protocol ID
- AEF0117-107
- Other IDs
- U01DA053832
- Acronym
- DDI
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2024
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-controlled Trial in Healthy Volunteers to Investigate the Effect of Multiple Oral Doses of AEF0117 Versus Placebo on the Pharmacokinetics of THC and Its Metabolites 11 OH THC and THC COOH When Smoking Cannabis.
- ClinicalTrials.gov ID
- NCT06395688
- Acronym / sponsor ID
- DDI / AEF0117-107
- Conditions
- Cannabis Abuse
- Keywords
- Cannabis use disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to several issues, this study has never been submitted to the IRB. So the sponsor was decided to withdraw it.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aelis FarmaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 May 2024 (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 trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence.
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.
Detailed description
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis.
Participants will be male or female in good health aged from 21y to 55y old and who are recreational cannabis users.
The participant will receive either AEF0117 (2 mg) or placebo. The sponsor team, the research staff and the participant won't know which study medication has been given.
The main objectives of the trial are:
- To compare the effect of AEF0117 multiple doses on the maximal plasma concentration and other pharmacokinetic parameters of the THC and its metabolites.
- To investigate safety and tolerability of multiple doses of AEF0117 and when co-administered with a dose of smoked cannabis.
The participant will come for 2 inpatient phases (including one overnight stay). Those 2 inpatient phases are separated by 5 days at home.
After a screening period assessing the good health and the eligibility of the participant, on day 1 they will receive 2 capsules of the study medication and will smoke one cannabis cigarette. During the day, blood samples will be collected at defined timepoints before the study medication, after the study medication and before smoking and after smoking.
On day 2, Blood samples will be collected before and after the study medication intake.
At the end of the assessements, the participant will be discharged. They could be requested to stay at the research facility if they experience any adverse effects From Day 3 to Day 7, the participant will be contacted by phone or by videoconference to confirm the study medication intake and if they experience any adverse events.
On day 8, the participant will come back to the research facility for a 2 days visit including an overnight stay. Assessments and procedures will similar to those performed on Day 1 and Day 2.
On Day 14, the participant will come back to the research facility a last time for a final blood collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| AEF0117 | Experimental | Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one, Drug: PlaceboParticipant will be administered once daily 2 placebo capsules for 1 day and 2 AEF0117 capsules for 7days |
| Placebo | Placebo comparator | Drug: PlaceboParticipant will be administered once daily 2 placebo capsules for 8 days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males and females of any race, 21 to 55 years old, both inclusive.
- Subjects must use highly effective contraception.
- Body mass index (BMI) between 20.0 and ≤35.0 kg/m2 at screening.
- Be informed of the nature of the trial and provide written informed consent.
- Be legally competent and able to communicate effectively (in English) with trial personnel.
Key exclusion criteria (20 listed)
- Severe learning disability, brain damage, or pervasive developmental disorder.
- Any disease or condition that according to the investigator's medical judgment might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- Any clinical laboratory values assessed as clinically significant by the investigator.
- a) A history of alcohol- or substance use disorders within the past 2 years, recent or current regular use of any illicit drugs except cannabis. In case of a positive drug screen (except for cannabis) at screening, a negative test is required at re-screening.
- A history of or current serious mental illness including active or recent suicidal ideation, severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder), and/or an abnormal Columbia-Suicide Severity Rating Scale (C-SSRS) result (i.e., a C-SSRS score of ≥3).
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 |
|---|---|---|
| 3ß-(4-methoxybenzyloxy)pregn-5-en-20-oneAlso: AEF0117AEF0117 soft capsules of 1mg | Drug | AEF0117 |
| PlaceboPlacebo soft capsules (identical to active compound) | Drug | AEF0117, Placebo |
Primary outcome
Cmax for co-administration of THC and AEF0117
Time frame: Day1, Day8
Comparison of the maximal plasma concentration (Cmax) of THC after co-administration of cannabis cigarette and AEF0117 versus co-administration of cannabis cigarette and placebo.
12 secondary outcomes
AUC for co-administration of THC and AEF0117
Time frame: Day1, Day8
Tmax for co-administration of THC and AEF0117
Time frame: Day1, Day8
Tlag for co-administration of THC and AEF0117
Time frame: Day1, Day8
Clast for co-administration of THC and AEF0117
Time frame: Day1, Day8
t1/2 for co-administration of THC and AEF0117
Time frame: Day1, Day8
Cmax for 11-OH-THC and THC-COOH
Time frame: Day1, Day8
AUC for 11-OH-THC and THC-COOH
Time frame: Day1, Day8
Tmax for 11-OH-THC and THC-COOH
Time frame: Day1, Day8
Tlag for 11-OH-THC and THC-COOH
Time frame: Day1, Day8
Incidence of TEAEs or TESAEs
Time frame: From Day1 to Day14
Incidence of TEAEs and TESAEs assessed by vital signs
Time frame: Day1, Day2, Day8, Day9, Day14
Effect on heart rate
Time frame: Day1, Day8
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Margaret Haney, PhD principal investigator
New York Institute Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in people with Cannabis Abuse, run by Aelis Farma.
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: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax for co-administration of THC and AEF0117 (time frame: Day1, Day8). 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 27 Feb 2026.