PRIMARY STUDY
Signaling-specific inhibition of the CB1 receptor for cannabis use disorder: phase 1 and phase 2a randomized trials
Key Findings: AEF0117 is a novel inhibitor of the cannabinoid receptor 1 that selectively inhibits certain effects of Δ9-tetrahydrocannabinol (THC). In this study, AEF0117 reduced the positive subjective effects of cannabis and reduced cannabis self-administration suggesting its use may be beneficial in cannabis use disorders.
Type of Study: Double Blind Clinical Trial
Study Sample Size: 24
Study Result: Positive
Research Location(s): France, New Zealand, Spain, United States
Year of Pub: 2023
Cannabinoids Studied: Tetrahydrocannabinol (THC), Synthetic Cannabinoid (unspecified)
Phytocannabinoid Source: Not Applicable
Receptors Studied: CB1
DOSING DETAILS 
Study Dosing Objective: Effective Dose, Safety Profile,
Established Protocol: Effective dose
Route of Administration: Oral (Ingestion)
Dosage Form: soft oval gelatin capsules containing a solution of AEF0117 in corn oil
Dosing Regimen: Single-ascending dose AEF0117 : 0.2 mg, 0.6 mg, 2 mg and 6 mg Multiple ascending doses AEF0117: 0.6 mg, 2 mg and 6 mg once a day versus placebo
Starting Dose: AEF0117 0.2 mg or 0.6 mg
Maximum Dose: AEF0117 6mg
Treatment Duration: 7 days
Clinical Relevance: Through a novel mechanism of action, AEF0117 shows promise as a possible therapeutic option for future use in treating withdrawal symptoms of cannabis use disorder.
Adverse Events: one moderate episode of pruritus and cutaneous rash after the first administration of 0.6 mg of AEF0117
Additional Notes: Clinical Trial Phase I, Clinical Trial Phase II, Parallel Dose Comparison, Dose Escalation
Citation: Haney M, et al. Signaling-specific inhibition of the CB1 receptor for cannabis use disorder: phase 1 and phase 2a randomized trials. Nat Med. 2023; 29:1487-1499. doi: 10.1038/s41591-023-02381-w
Authors: Haney M, Vallée M, Fabre S, Collins Reed S, Zanese M, Campistron G, Arout CA, Foltin RW, Cooper ZD, Kearney-Ramos T, Metna M, Justinova Z, Schindler C, Hebert-Chatelain E, Bellocchio L, Cathala A, Bari A, Serrat R, Finlay DB, Caraci F, Redon B, Martín-García E, Busquets-Garcia A, Matias I, Levin FR, Felpin FX, Simon N, Cota D, Spampinato U, Maldonado R, Shaham Y, Glass M, Thomsen LL, Mengel H, Marsicano G, Monlezun S, Revest JM, Piazza PV
