Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD)

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. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. 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. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.

The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This study will provide additional data on the efficacy of AEF0117 on treatment-seeking subjects with moderate to severe CUD.

This is a phase 2b, randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of RESPONDERS (i.e., subjects with a RESPONSE of ≤1 day of cannabis use per week) compared to placebo in treatment-seeking subjects with moderate to severe CUD, according to DSM-5 criteria.The secondary objectives are to investigate the proportion of subjects that reach various levels of reduction and how this influences their quality of life, and to evaluate the safety and tolerability of AEF0117. And the exploratory objectives of this study are to further evaluate the effect of AEF0117 on pattern of cannabis use and change in various signs and symptoms, and in addition to assess effects during the grace period and the entire treatment period.

Conditions

• Marijuana Abuse

Interventions

DRUG

AEF0117

AEF0117 (1.0, 0.3, and 0.1 mg) capsules

DRUG

Placebo oral capsule

Corn oil capsule manufactured to mimic AEF0117 capsule

Sponsors & Collaborators

• Aelis Farma

  lead INDUSTRY

Principal Investigators

• Frances Levin, MD · Columbia University/NYSPI

• Jennifer Wisdom, MD · CODA Inc, Research Department

• Kevin Gray, MD · Addiction Sciences Division - Medical University of South Carolina

• Jennifer Potter, MD · Department of Psychiatry and Behavioral Sciences - UT Health San Antonio.

• Larissa Mooney, MD · Department of Psychiatry and Biobehavioral Sciences - UCLA

• Rajita Sinha, MD · Addiction Program- Yale Stress Center

• Richi Kakar, MD · Segal Trials

• Paul Thielking, MD · CEDAR Salt Lake city

• Olga Lapeyra, MD · Behavioral Clinical Research

• Haig Goenjian, MD · CEnExel CNR

• Matt Evans, MD · CEDAR Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-06

Primary Completion

2024-04-11

Completion

2024-07-22

FDA Drug

Yes

Countries

• United States

Study Locations