Drug-Drug Interaction Between THC and AEF0117 (NCT06395688) | Clinical Trial Compass
WithdrawnPhase 1
Drug-Drug Interaction Between THC and AEF0117
Stopped: Due to several issues, this study has never been submitted to the IRB. So the sponsor was decided to withdraw it.
0Started 2025-12
Plain-language 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 cannabis.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
. 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.