Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts

Summary

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder. 2.2. Specifics * Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group * Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group * Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo * Evaluate the incidence and severity of side effects in the active group compared to placebo.

Timeline

Start

2023-10-23

Primary completion

2024-10-23

Completion

2025-10-23

Publications

• Background Karimi-Haghighi S, Razavi Y, Iezzi D, Scheyer AF, Manzoni O, Haghparast A. Cannabidiol and substance use disorder: Dream or reality. Neuropharmacology. 2022 Apr 1;207:108948. doi: 10.1016/j.neuropharm.2022.108948. Epub 2022 Jan 13.
• Background Ledesma JC, Manzanedo C, Aguilar MA. Cannabidiol prevents several of the behavioral alterations related to cocaine addiction in mice. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Dec 20;111:110390. doi: 10.1016/j.pnpbp.2021.110390. Epub 2021 Jun 19.
• Background Mongeau-Perusse V, Brissette S, Bruneau J, Conrod P, Dubreucq S, Gazil G, Stip E, Jutras-Aswad D. Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Addiction. 2021 Sep;116(9):2431-2442. doi: 10.1111/add.15417. Epub 2021 Feb 9.

Drugs

Indications