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[4-14C] AEF0117 for Cannabis Abuse

Phase 1
Waitlist Available
Led By Irene Mirkin, MD
Research Sponsored by Aelis Farma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1008 hours postdose
Awards & highlights

Study Summary

This trial is testing a new drug, AEF0117, to see if it can help people with cannabis abuse disorders. The drug acts on the same parts of the brain as THC, the active ingredient in marijuana, and may change some of the effects of cannabis. The trial will involve a single dose of the drug given to healthy male subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1008 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1008 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Elimination Disorders
Area under the concentration-time curveof AEF0117
Feces excretion of [4-14C]AEF0117
+4 more
Secondary outcome measures
Identification of potential metabolites
Incidence of laboratory abnormalities
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [4-14C] AEF0117Experimental Treatment1 Intervention
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low-fat breakfast
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AEF0117
2022
Completed Phase 2
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,585 Total Patients Enrolled
9 Trials studying Cannabis Abuse
335,134 Patients Enrolled for Cannabis Abuse
Aelis FarmaLead Sponsor
9 Previous Clinical Trials
666 Total Patients Enrolled
Irene Mirkin, MDPrincipal InvestigatorSubstance Use Research Center
6 Previous Clinical Trials
135 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project allow patients who are over 75 years old to participate?

"The eligibility requirements for this clinical trial state that potential participants must be aged between 18-65. There are 16 studies for patients who are under 18 and 49 for patients that are over 65."

Answered by AI

Could you summarize the objectives of this research?

"The primary goal of this study is to assess the maximum observed concentration of AEF0117 over a period of up to 648 hours. Other objectives include identifying potential metabolites, assessing the incidence of treatment-emergent adverse events, and evaluating changes in vital signs from baseline."

Answered by AI

If I join this research project, will I be a good candidate?

"To participate in this hashish abuse trial, potential candidates must be between 18 and 65 years old. At maximum, 8 people will be accepted."

Answered by AI

What is the [4-14C] AEF0117 FDA approval status?

"[4-14C] AEF0117's lack of clinical data supporting safety and efficacy resulted in a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects
2022. "Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554926.
~3 spots leftby Apr 2025
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