Título:	Cannabidiol compared to pharmacological treatment as usual for crack use disorder : a feasibility, preliminary efficacy, parallel, double‑blind, randomized clinical trial
Autor(es):	Gallassi, Andrea Donatti Oliveira, André Wagner Carvalho de Rodrigues, Larissa Alencar Nakano, Eduardo Yoshio Ruas, Pedro A. S. La Mata, José Antonio Iturri de Ferrari Júnior, Ettore Gomes, Juliano de Andrade Caroba, Mariana Emanuele Silva Silva, Marianna Gabriella dos Santos Vieira, Mariana G. Q. Reis, Julia G. G. R. Leite, Jade Luiza Moreira Lima, Guilherme Henrique Alves de Lima, Jonathan Morais Lima, Yasmim P. V Ribas, Jorge A. A. Chagas, Nathalia A. L. das Magalhães, Mateus A. Silva, Mateus F. da Filev, Renato Lopes, Renato José Rodrigues Malcher
ORCID:	http://orcid.org/0000-0003-1852-485X https://orcid.org/0000-0001-8041-2133 https://orcid.org/0000-0002-6469-4318 https://orcid.org/0000-0002-9071-8512 https://orcid.org/0000-0002-1310-2634 https://orcid.org/0000-0002-6598-1861 https://orcid.org/0000-0002-2953-7878 https://orcid.org/0000-0001-5990-765X https://orcid.org/0000-0003-1194-1407 https://orcid.org/0000-0002-1484-3856 https://orcid.org/0000-0002-8274-7882 https://orcid.org/0000-0002-1129-2163 https://orcid.org/0000-0003-2487-0118 https://orcid.org/0000-0001-8571-1351 https://orcid.org/0000-0002-0273-0635 https://orcid.org/0000-0002-9782-9258 https://orcid.org/0000-0002-4363-2011 https://orcid.org/0000-0002-4980-6799 https://orcid.org/0000-0001-7628-9267 https://orcid.org/0000-0002-9238-0455 https://orcid.org/0000-0002-4941-9908
Afiliação do autor:	Universidade de Brasília, Faculdade de Ceilândia, Graduate Program in Health Sciences and Technology Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Graduate Program in Health Sciences and Technology Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Graduate Program in Health Sciences and Technology Secretary of Health of the Brazilian Federal District Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Public Health Civil Police of the Brazilian Federal District, Forensic Institute Civil Police of the Brazilian Federal District, Forensic Institute Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Occupational Therapy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Occupational Therapy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Occupational Therapy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Occupational Therapy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Faculdade de Ceilândia, Center of Drugs and Associated Vulnerabilities Universidade de Brasília, Faculdade de Ceilândia, Undergraduate Program in Pharmacy Universidade de Brasília, Campus Darcy Ribeiro, Institute of Psychology Universidade Federal de São Paulo, Orientation and Assistance Program for Dependents Universidade de Brasília, Campus Darcy Ribeiro, Institute of Biology
Assunto:	Canabidiol Crack (Droga) Drogas - abuso - psicologia Transtornos relacionados ao uso de substâncias Saúde Ensaio clínico
Data de publicação:	Mar-2024
Editora:	Springer Nature
Referência:	GALLASSI, Andrea et al. Cannabidiol compared to pharmacological treatment as usual for crack use disorder: a feasibility, preliminary efficacy, parallel, double‑blind, randomized clinical trial. International Journal of Mental Health and Addiction, [S. l.], v. 23, p. 3222–3246, 2025. DOI: https://doi.org/10.1007/s11469-024-01287-z. Disponível em: https://link.springer.com/article/10.1007/s11469-024-01287-z. Acesso em: 13 maio. 2026.
Abstract:	Cannabidiol (CBD) has been studied for substance use disorders treatment due to its anxiolytic effects, for sleep, appetite, reduction of craving, and maintenance of abstinence. The study aims to assess CBD’s feasibility, safety/tolerability, and preliminary efficacy compared to pharmacological treatment as usual for reducing crack use in people with crack use disorder (CUD) and investigate other parameters: adverse events, physical health symptoms, and craving. A double-blind, randomized clinical trial (RCT) with two treatment arms (CBD and control group) was conducted. Ninety participants were randomized and 73 were allocated: 37 control group and 36 CBD group for a 10-week treatment, comparing CBD (600 mg) with three drugs (fluoxetine, valproic acid, and clonazepam). The per-protocol analysis of participants who did not deviate from the study protocol compared the control and CBD treatment groups. Thirty-four completed at least half of the study and 25 finished. Participants attended weekly meetings for the study procedures (e.g., to receive the medication and provide urine for toxicological tests). Inter-group differences were performed with the Mann–Whitney test, the Wilcoxon test for differences intra-group, and Pearson’s Chi-square test or Fisher’s exact test to compare inter-group demographic data. The significance level was 5%. A “veracity index” (VI) was created as counterevidence (questionnaire data vs. the toxicological test result). Medications were considered safe/tolerable. The CBD group presented significantly fewer adverse events compared to the control group [e.g., dizziness (p = 0.001), memory impairment (p = 0.043)], which performed better in the reduction of clinical and psychiatric complaints (p = 0.008). In the intra-group analyses, the CBD group performed better in more parameters than the control group [e.g., reducing crack use (p = 0.016; T0 to T1)]. Data questionnaires were reliable regarding the use/non-use of crack (VI = 0.787). CBD is a safe/tolerable product. The CBD group manifested fewer adverse events than the control group, which had better clinical and psychiatric complaints results. There are some advantages for the CBD group in the intra-group analysis. Drug use self-report methodologies can be reliable. Trial registration details: This study is registered with Universal Trial Number (UTN) code: U1111-1234- 0806.
Unidade Acadêmica:	Faculdade de Ciências e Tecnologias em Saúde (FCTS) – Campus UnB Ceilândia Curso de Terapia Ocupacional (FCTS-TER) Faculdade de Ciências da Saúde (FS) Departamento de Farmácia (FS FAR) Departamento de Saúde Coletiva (FS DSC) Instituto de Ciências Exatas (IE) Departamento de Estatística (IE EST) Instituto de Psicologia (IP) Instituto de Ciências Biológicas (IB) Departamento de Ciências Fisiológicas (IB CFS)
Programa de pós-graduação:	Programa de Pós-Graduação em Ciências e Tecnologias em Saúde
Licença:	Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
DOI:	https://doi.org/10.1007/s11469-024-01287-z
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