Cannabidiol Compared to Pharmacological Treatment as Usual for Crack Use Disorder: A Feasibility, Preliminary Efficacy, Parallel, Double-Blind, Randomized Clinical Trial.

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 trea...

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Publicado en:International Journal of Mental Health & Addiction Vol. 23; no. 4; pp. 3222 - 3247
Autores principales: Gallassi, Andrea Donatti, de Oliveira, André Wagner Carvalho, Rodrigues, Larissa Alencar, Nakano, Eduardo Yoshio, Ruas, Pedro A. S., de La Mata, José Antonio Iturri, Júnior, Ettore Ferrari, de Andrade Gomes, Juliano, Caroba, Mariana Emanuele Silva, dos Santos Silva, Marianna Gabriella, Vieira, Mariana G. Q., Reis, Julia G. G. R., Leite, Jade Luiza Moreira, de Lima, Guilherme Henrique Alves, Lima, Jonathan Morais, Lima, Yasmim P. V., Ribas, Jorge A. A., das Chagas, Nathalia A. L., Magalhães, Mateus A., da Silva, Mateus F.
Formato: Case Study
Publicado: Springer Nature Aug2025
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Acceso en línea:Ver este registro en EBSCOhost
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      dt: Aug2025
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      pub: Springer Nature
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        atl: Cannabidiol Compared to Pharmacological Treatment as Usual for Crack Use Disorder: A Feasibility, Preliminary Efficacy, Parallel, Double-Blind, Randomized Clinical Trial.
      aug:
        au:
          Gallassi, Andrea Donatti
          de Oliveira, André Wagner Carvalho
          Rodrigues, Larissa Alencar
          Nakano, Eduardo Yoshio
          Ruas, Pedro A. S.
          de La Mata, José Antonio Iturri
          Júnior, Ettore Ferrari
          de Andrade Gomes, Juliano
          Caroba, Mariana Emanuele Silva
          dos Santos Silva, Marianna Gabriella
          Vieira, Mariana G. Q.
          Reis, Julia G. G. R.
          Leite, Jade Luiza Moreira
          de Lima, Guilherme Henrique Alves
          Lima, Jonathan Morais
          Lima, Yasmim P. V.
          Ribas, Jorge A. A.
          das Chagas, Nathalia A. L.
          Magalhães, Mateus A.
          da Silva, Mateus F.
        affil:
          https://ror.org/02xfp8v59 Graduate Program in Health Sciences and Technology (Programa de Pós-Graduação em Ciências e Tecnologias em Saúde), Faculdade de Ceilândia (FCE), Universidade de Brasília (UnB), Brasília, DF, Brazil
          https://ror.org/02xfp8v59 Center of Drugs and Associated Vulnerabilities (Centro de Referência sobre Drogas e Vulnerabilidades Associadas), FCE, UnB, Brasília, DF, Brazil
          Statistical Department (Departamento de Estatística), UnB-Campus Darcy Ribeiro, Brasília, DF, Brazil
          https://ror.org/03afd8w19 Secretary of Health of the Brazilian Federal District (Secretaria de Estado da Saúde do Distrito Federal), Brasília, DF, Brazil
          https://ror.org/02xfp8v59 Undergraduate Program in Public Health (Curso de Graduação em Saúde Coletiva), FCE, UnB, Brasília, DF, Brazil
          Forensic Institute, Civil Police of the Brazilian Federal District (Instituto de Criminalística da Polícia Civil do Distrito Federal-PCDF), Brasília, DF, Brazil
          https://ror.org/02xfp8v59 Undergraduate Program in Occupational Therapy (Curso de Graduação em Terapia Ocupacional), FCE, UnB, Brasília, DF, Brazil
          https://ror.org/02xfp8v59 Undergraduate Program in Pharmacy (Curso de Graduação em Farmácia), FCE, UnB, Brasília, DF, Brazil
          Institute of Psychology (Instituto de Psicologia), UnB-Campus Darcy Ribeiro, Brasília, DF, Brazil
      su:
        Clinical trials
        Randomized controlled trials
        Cocaine abuse
        Substance-induced disorders
        Cannabidiol
        Treatment effectiveness
        Safety
        Adverse health care events
      sug:
        subj:
          Clinical trials
          Randomized controlled trials
          Cocaine abuse
          Substance-induced disorders
          Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
          Cannabidiol
          Treatment effectiveness
          Safety
          Adverse health care events
      keyword:
        Adverse events, craving
        Clinical trial
        Crack use disorder
        Medical and Health Sciences Clinical Sciences Public Health and Health Services
        Physical health symptoms
        Recall-induced craving
        Adverse events, craving
        Clinical trial
        Crack use disorder
        Medical and Health Sciences Clinical Sciences Public Health and Health Services
        Physical health symptoms
        Recall-induced craving
      ab: 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. Available at https://ensaiosclinicos.gov.br/rg/RBR-4stgs8 (Effect of cannabidiol in the treatment of crack dependents)
      pubtype: Academic Journal
      doctype: Case Study
      src: R
    language: English
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