What side effects are associated with this type of intervention?

Common treatments for cannabis abuse, including THC preparations, varenicline, and topiramate, have various side effects. THC preparations can cause sedation and other neuropsychiatric symptoms. Varenicline, used for smoking cessation and cannabis use disorder, may lead to nausea, insomnia, and abnormal dreams. Topiramate, an anticonvulsant, has been associated with impaired concentration, confusion, dizziness, anxiety, and paresthesias. These side effects highlight the need for careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of cannabis use disorder. Several drugs, such as varenicline, nabiximols, cannabidiol, and topiramate, have been studied for their potential efficacy in treating cannabis dependence, but none have received FDA approval for this indication. AEF0117 is an investigational drug being studied for its pharmacokinetics and bioavailability, showing promise as a potential treatment for cannabis abuse.

What other types of research exist?

Promising novel alternatives to AEF0117 for treating cannabis abuse include nabiximols and cannabidiol. Nabiximols, a cannabinoid spray, has shown efficacy in reducing cannabis use when combined with psychosocial interventions. Cannabidiol, another major cannabinoid, has demonstrated effectiveness in reducing THC metabolite levels and increasing abstinence days in clinical trials. Both treatments have been well tolerated with no serious adverse effects reported.

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3ß-(4-methoxybenzyloxy)pregn-5-en-20-one for Cannabis Abuse

Phase 1

Waitlist Available

Led By Margaret Haney, PhD

Research Sponsored by Aelis Farma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight of 50.0-100.0 kg (inclusive), with a body mass index (BMI) of 18.0-310.0 kg/m2 (inclusive).

Healthy, non-smoking male or female of any race, 18 to 55 years old, both inclusive

Must not have

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

Severe learning disability, brain damage, or pervasive developmental disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AEF0117 to help people who struggle with cannabis use. The drug works by blocking the effects of THC, the main active ingredient in cannabis. It is aimed at people who have difficulty reducing or stopping their cannabis use with current treatments. The trial will also study how food affects the drug's absorption in the body.

Who is the study for?

Healthy adults aged 18-55, non-smokers with a BMI of 22.0-35.0 kg/m2 can join this trial. They must use effective contraception and not plan pregnancy or sperm donation during the trial. Participants should understand English, be able to eat a high-fat meal quickly, and have no history of serious drug abuse or mental illness.

What is being tested?

The study tests how food affects the absorption of AEF0117, a potential treatment for cannabis abuse disorder. It compares how well the body absorbs the drug when taken with food versus without food (fasting) in healthy volunteers.

What are the potential side effects?

While specific side effects are not listed here, previous studies show that AEF0117 is generally safe and tolerable. However, as with any medication, there may be risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 50 and 100 kg, and my BMI is between 18 and 31.

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I am a healthy, non-smoking person aged 18 to 55.

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I will use effective birth control throughout the trial.

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I agree to use condoms and spermicide as birth control.

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I am a woman who cannot become pregnant because I am either surgically sterile or post-menopausal.

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I can legally make my own decisions and can communicate in English with the trial team.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that could affect my heart, blood, kidneys, liver, lungs, hormones, brain, or stomach.

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I have a severe learning disability, brain damage, or a pervasive developmental disorder.

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I haven't donated blood or received blood transfusions in the last month and my hemoglobin is above 9 g/dL.

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I have or had HIV, hepatitis B, or hepatitis C.

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I have had COVID-19 or tested positive for it within the last 4 weeks.

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I am not allergic to the trial drug, pregnenolone, or corn products.

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I haven't used any substances that affect liver drug processing in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pharmacokinetic measures (e.g.2, 4, 6, 8, 11, 24, 72 and 144 hours post dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bioavailibility of AEF0117 (tlast)

Cmax of AEF0117

Tmax of AEF0117

Secondary study objectives

AUC (area under curve) of AEF0117

Incidence of Treatment-Emergent Adverse Events [safety and tolerability]

Lowest Peak Plasma (Cmin) of AEF0117 plasma exposure

+1 more

Other study objectives

AUC of Plasma concentrations of AEF0117 potential metabolites

Peak Plasma Concentration (Cmax) of AEF0117 potential metabolites

Time to maximum plasma concentration (tmax) of AEF0117 potential metabolites

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: AEF0117 1.0 mg once daily (QD) in fed conditionExperimental Treatment1 Intervention

16 participants receive 1 dose of AEF0117 1 mg fed condition

Group II: AEF0117 1.0 mg in fasted conditionExperimental Treatment1 Intervention

16 participants receive 1 dose of AEF0117 1 mg in fasted condition

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cannabis Abuse include varenicline, topiramate, gabapentin, and cannabidiol. Varenicline works as a selective nicotinic acetylcholine receptor agonist, which helps reduce cravings and withdrawal symptoms. Topiramate, an antiepileptic agent, modulates neurotransmitter receptors and ion channels, reducing cannabis use and withdrawal symptoms. Gabapentin, a GABAergic agent, decreases cannabis use and withdrawal symptoms by stabilizing neural activity. Cannabidiol, a major cannabinoid, reduces cannabis use by modulating the endocannabinoid system without producing psychoactive effects. These mechanisms are crucial for patients as they target the neurobiological pathways involved in addiction, helping to reduce dependence and improve abstinence rates.