Marijuana AbusePhase 1NCT05451017
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
A Phase 1 study testing 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition and 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition in people with Marijuana Abuse, run by Aelis Farma at 1 site in United States.
Trial summary
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition and 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 28 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive.
- Both males and female participants must use highly effective contraception during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Male participants must agree to use double-barrier contraceptive methods: male condoms and spermicide. FHeterosexually active females are only eligible if they are documented to be surgically sterile (e.g., hysterectomy, tubal ligation) or post-menopausal (amenorrhea >1 year and follicle-stimulating hormone [FSH] >25.8 mIU/mL) and with a negative pregnancy test.
- Body mass index (BMI) of 22.0-35.0 kg/m2 (inclusive).
- Be informed of the nature of the trial and provide signed informed consent to participate in the trial prior to any trial-specific procedures.
- After being shown the high fat meal, understands and accepts that the entire meal should be consumed within 30 minutes.
- Be legally competent and able to communicate effectively (in English) with trial personnel.
Who cannot join
- Tobacco cigarette smokers within the last 3 months prior to dosing with trial drug.
- Any disease or condition that might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer and cholecystectomy) systems, or any clinical laboratory values assessed as potentially clinically significant by the investigator .
- Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant.
- Congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening.
- A corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470 msec (female) or history of risk factors for Torsades de Pointes.
- A history of alcoholism or drug addiction within the past 2 years, recent use (in the last month) of any illicit drugs, or positive results from a urine screen for substances of abuse or from an alcohol breath test.
Show all 19Show fewer
- 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.
- Severe learning disability, brain damage, or pervasive developmental disorder.
- A history of difficulty donating blood or inadequate venous access.
- Clinically significant anemia or low hemoglobin (levels <9 g/dL) at screening, or donation of >250 mL of blood or plasma within the 30 days prior to prior to receiving trial drug or received any blood and plasma for medical/surgical reasons within the 30 days prior to prior to receiving trial drug, or intention to donate blood or plasma within 1 month after receiving trial drug.
- History of or current HIV or hepatitis B or C.
- History of COVID-19 within 4 weeks prior to Day -1, or positive COVID 19 test, according to standard procedures at the site, at screening or Day 1.
- Positive serum pregnancy test (ß-hCG) at screening or positive urine pregnancy test at Day 1 confirmed by a serum pregnancy test result.
- Allergies to the trial drug and known allergies to pregnenolone or to corn and corn derivatives.
- Use of any prescription or over-the-counter drug therapy, including psychoactive and/or psychotropic medication, herbal, homeopathic, vitamins, minerals, and nutritional supplements, bodybuilding 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 a drug therapy, or diet or supplements (e.g., St. John's Wort) food and fruit juices (e.g., grapefruit juice) known to induce or inhibit hepatic drug metabolism within 30 days prior to receiving trial drug or during the trial.
- Legal status that would interfere with participation.
- Unable to follow the restrictions outlined in the protocol.
- Ingestion of an investigational drug or product, or participation in a drug trial within a period of 90 days prior to receiving trial drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Use Research Center
New York, New York, 10032
About this study
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders.
Read more
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
Read the detailed description
Cannabis is the most widely used illicit drug with approximately 28 million individuals reporting past-month use, and 14% of those receiving substance use disorder treatment in the US reporting cannabis as their primary drug of abuse. While psychotherapeutic approaches have some utility for treating Cannabis Use Disorder (CUD), the vast majority of patients have difficulty significantly reducing their use or achieving abstinence. Safe and effective medications to treat CUD are urgently needed. The overall goal of this clinical trial is to contribute to advancing a safe and effective pharmacotherapy for CUD along the FDA approval pipeline.
When the CB1 receptors are over-activated by very high doses of THC, quite higher than the doses of THC used by cannabis abusers, the concentration of the steroid hormone pregnenolone increases in the brain. Pregnenolone then binds to a specific site on the CB1 receptors, distinct for the one of CB1 agonists and THC, and acts as an endogenous signaling specific inhibitor of the CB1 receptors. Pregnenolone cannot be used as a pharmacological treatment because it is poorly bioavailable, has a very short half-life and is converted downstream to active steroids. Aelis Farma, in collaboration with researchers from the Institut National de la Santé et de la Recherche Médicale (INSERM), has developed a new pharmacological class, the synthetic signaling specific inhibitor of the CB1 receptor (sCB1-SSi) AEF0117, by modifying pregnenolone's chemical structure to prevent conversion to active steroids, and to increase absorption and biological stability while maintaining THC antagonism.
To date, 3 clinical studies have been completed with AEF0117 including 2 phase 1 studies in healthy volunteers (AEF0117-101 single ascending dose study and AEF0117 102, multiple ascending dose study), and a phase 2a trial in cannabis users (AEF0117 201). The phase 1 studies showed good safety and tolerability of AEF0117 in the dose range tested (0.2 mg as single dose and 0.6-6 mg/day as single and multiple doses) and the phase 2a trial found that the 1 mg/day dose of AEF0117 significantly reduced both the abuse-related subjective effects of cannabis and its self-administration, while the 0.06 mg dose did not. Importantly, AEF0117 was well tolerated in daily cannabis smokers, with no evidence of precipitated withdrawal, physical, or psychological discomfort. There were no SAEs and a limited number of TEAEs. These results confirm preclinical data showing that AEF0117 does not function as an orthosteric antagonist and does not produce any of the adverse effects associated with rimonabant. Thus, AEF0117 is to our knowledge the first medication to safely and robustly attenuate the positive subjective and reinforcing effects of cannabis in participants with CUD.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
- Conditions
- Marijuana Abuse
- Being tested
- 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition, 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition
- Keywords
- AEF0117, Cannabis-related Use Disorder, Cannabis subjective effects, Cannabis self-administration cannabis-induced analgesia, Cannabis-related cognitive 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-one in fed conditionDrug
Also called AEF0117
a single dose of 1 mg AEF0117 in fed condition
3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting conditionDrug
Also called AEF0117
a single dose of 1 mg AEF0117 in fasting condition
| Study group | Role | What they receive |
|---|---|---|
| AEF0117 1.0 mg in fasted condition | Experimental | 16 participants receive 1 dose of AEF0117 1 mg in fasted condition Receives: Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition |
| AEF0117 1.0 mg in fed condition | Experimental | 16 participants receive 1 dose of AEF0117 1 mg fed condition Receives: Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of AEF0117
Plasma concentration maximum(Cmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Measured: up to 312 hours after dosing
Tmax of AEF0117
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Measured: up to 312 hours after dosing
AUC (Area Under Curve) t to Last Concentration of AEF0117
Area under the plasma concentration (AUC to Last Nonzero Conc) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Measured: up to 312 hours after dosing
AUC (Area Under Curve) t to Infinity Observed of AEF0117
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Measured: up to 312 hours after dosing
Bioavailibility of AEF0117 (Tlag)
Tlag is the Time point of first quantifiable concentration after dose administration
Measured: up to 312 hours after dosing
Secondary outcomes (3)
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure
Lowest Peak Plasma (Cmin) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Measured: up to 312 hours after dosing
Terminal Elimination Half-life (t1/2) of AEF0117
Terminal elimination half-life (t1/2) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Measured: up to 312 hours after dosing
Incidence of Treatment-Emergent Adverse Event
Number of participant reporting at least one Adverse Event
Measured: up to 312 hours after AEF0217 dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start4 Jan 2023
- Primary completion26 Jun 2023
- Study completion28 Jun 2023
Why it stopped: Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, randomized, parallel-group, 2-arm, open-label, single-dose trial in healthy male and female volunteers aged 18-55 years to obtain data on the effect of food on the oral bioavailability of AEF0117.
- Masking
- None (open label)
- Enrolment
- 22 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, Substance Use Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451017
- Sponsor's protocol ID
- AEF0117-105
- Other IDs
- U01DA053832
- Status last verified
- Jan 2026
- First submitted
- 27 Jun 2022
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05451017
- Acronym / sponsor ID
- AEF0117-105
- Conditions
- Marijuana Abuse
- Keywords
- AEF0117, Cannabis-related Use Disorder, Cannabis subjective effects, Cannabis self-administration cannabis-induced analgesia, Cannabis-related cognitive disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aelis FarmaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
Detailed description
Cannabis is the most widely used illicit drug with approximately 28 million individuals reporting past-month use, and 14% of those receiving substance use disorder treatment in the US reporting cannabis as their primary drug of abuse. While psychotherapeutic approaches have some utility for treating Cannabis Use Disorder (CUD), the vast majority of patients have difficulty significantly reducing their use or achieving abstinence. Safe and effective medications to treat CUD are urgently needed. The overall goal of this clinical trial is to contribute to advancing a safe and effective pharmacotherapy for CUD along the FDA approval pipeline.
When the CB1 receptors are over-activated by very high doses of THC, quite higher than the doses of THC used by cannabis abusers, the concentration of the steroid hormone pregnenolone increases in the brain. Pregnenolone then binds to a specific site on the CB1 receptors, distinct for the one of CB1 agonists and THC, and acts as an endogenous signaling specific inhibitor of the CB1 receptors. Pregnenolone cannot be used as a pharmacological treatment because it is poorly bioavailable, has a very short half-life and is converted downstream to active steroids. Aelis Farma, in collaboration with researchers from the Institut National de la Santé et de la Recherche Médicale (INSERM), has developed a new pharmacological class, the synthetic signaling specific inhibitor of the CB1 receptor (sCB1-SSi) AEF0117, by modifying pregnenolone's chemical structure to prevent conversion to active steroids, and to increase absorption and biological stability while maintaining THC antagonism.
To date, 3 clinical studies have been completed with AEF0117 including 2 phase 1 studies in healthy volunteers (AEF0117-101 single ascending dose study and AEF0117 102, multiple ascending dose study), and a phase 2a trial in cannabis users (AEF0117 201). The phase 1 studies showed good safety and tolerability of AEF0117 in the dose range tested (0.2 mg as single dose and 0.6-6 mg/day as single and multiple doses) and the phase 2a trial found that the 1 mg/day dose of AEF0117 significantly reduced both the abuse-related subjective effects of cannabis and its self-administration, while the 0.06 mg dose did not. Importantly, AEF0117 was well tolerated in daily cannabis smokers, with no evidence of precipitated withdrawal, physical, or psychological discomfort. There were no SAEs and a limited number of TEAEs. These results confirm preclinical data showing that AEF0117 does not function as an orthosteric antagonist and does not produce any of the adverse effects associated with rimonabant. Thus, AEF0117 is to our knowledge the first medication to safely and robustly attenuate the positive subjective and reinforcing effects of cannabis in participants with CUD.
In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, randomized, parallel-group, 2-arm, open-label, single-dose trial in healthy male and female volunteers aged 18-55 years to obtain data on the effect of food on the oral bioavailability of AEF0117.
| Arm | Type | Receives |
|---|---|---|
| AEF0117 1.0 mg in fasted condition | Experimental | Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition16 participants receive 1 dose of AEF0117 1 mg in fasted condition |
| AEF0117 1.0 mg in fed condition | Experimental | Drug: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition16 participants receive 1 dose of AEF0117 1 mg fed condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive.
- Both males and female participants must use highly effective contraception during the entire trial period. Male participants should refrain from donating sperm or planning a pregnancy throughout the trial. Male participants must agree to use double-barrier contraceptive methods: male condoms and spermicide. FHeterosexually active females are only eligible if they are documented to be surgically sterile (e.g., hysterectomy, tubal ligation) or post-menopausal (amenorrhea >1 year and follicle-stimulating hormone [FSH] >25.8 mIU/mL) and with a negative pregnancy test.
- Body mass index (BMI) of 22.0-35.0 kg/m2 (inclusive).
- Be informed of the nature of the trial and provide signed informed consent to participate in the trial prior to any trial-specific procedures.
- After being shown the high fat meal, understands and accepts that the entire meal should be consumed within 30 minutes.
Key exclusion criteria (19 listed)
- Tobacco cigarette smokers within the last 3 months prior to dosing with trial drug.
- Any disease or condition that might compromise the cardiovascular, hematologic, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer and cholecystectomy) systems, or any clinical laboratory values assessed as potentially clinically significant by the investigator .
- Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant.
- Congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening.
- A corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470 msec (female) or history of risk factors for Torsades de Pointes.
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-one in fed conditionAlso: AEF0117a single dose of 1 mg AEF0117 in fed condition | Drug | AEF0117 1.0 mg in fed condition |
| 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting conditionAlso: AEF0117a single dose of 1 mg AEF0117 in fasting condition | Drug | AEF0117 1.0 mg in fasted condition |
Primary outcome
Cmax of AEF0117
Time frame: up to 312 hours after dosing
Plasma concentration maximum(Cmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
Tmax of AEF0117
Time frame: up to 312 hours after dosing
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions.
AUC (Area Under Curve) t to Last Concentration of AEF0117
Time frame: up to 312 hours after dosing
Area under the plasma concentration (AUC to Last Nonzero Conc) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
AUC (Area Under Curve) t to Infinity Observed of AEF0117
Time frame: up to 312 hours after dosing
Area under the plasma concentration (AUC infinity obs) based on serial blood sample collections and plasma AEF0117 concentration after fed conditions relative to fasting conditions
Bioavailibility of AEF0117 (Tlag)
Time frame: up to 312 hours after dosing
Tlag is the Time point of first quantifiable concentration after dose administration
3 secondary outcomes
Lowest Peak Plasma (Cmin) of AEF0117 Plasma Exposure
Time frame: up to 312 hours after dosing
Terminal Elimination Half-life (t1/2) of AEF0117
Time frame: up to 312 hours after dosing
Incidence of Treatment-Emergent Adverse Event
Time frame: up to 312 hours after AEF0217 dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Substance Use Research Center
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 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition and 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition in people with Marijuana Abuse, run by Aelis Farma 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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Jan 2026. 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. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of AEF0117 (time frame: up to 312 hours after dosing). The study lists 5 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 22 Jan 2026.