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Study on cannabis addiction drug halted early

NCT ID NCT05451017

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if taking the experimental drug AEF0117 with food changes how much gets into the bloodstream. It involved 22 healthy adults aged 18 to 55. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive. 2. 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. 3. Body mass index (BMI) of 22.0-35.0 kg/m2 (inclusive). 4. Be informed of the nature of the trial and provide signed informed consent to participate in the trial prior to any trial-specific procedures. 5. After being shown the high fat meal, understands and accepts that the entire meal should be consumed within 30 minutes. 6. Be legally competent and able to communicate effectively (in English) with trial personnel. Exclusion Criteria: 1. Tobacco cigarette smokers within the last 3 months prior to dosing with trial drug. 2. 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 . 3. Blood pressure outside normal range (140/80 mmHg systolic/diastolic) and considered potentially clinically significant. 4. Congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening. 5. A corrected QT interval (Fridericia's - QTcF) \>450 msec (male) or \>470 msec (female) or history of risk factors for Torsades de Pointes. 6. 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. 7. 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. 8. Severe learning disability, brain damage, or pervasive developmental disorder. 9. A history of difficulty donating blood or inadequate venous access. 10. 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. 11. History of or current HIV or hepatitis B or C. 12. 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. 13. Positive serum pregnancy test (ß-hCG) at screening or positive urine pregnancy test at Day 1 confirmed by a serum pregnancy test result. 14. Allergies to the trial drug and known allergies to pregnenolone or to corn and corn derivatives. 15. 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). 16. 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. 17. Legal status that would interfere with participation. 18. Unable to follow the restrictions outlined in the protocol. 19. Ingestion of an investigational drug or product, or participation in a drug trial within a period of 90 days prior to receiving trial drug.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Substance Use Research Center

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.