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Cannabidiol Cigarettes as Adjunctive Treatment for Psychotic Disorders – A Randomized, Open-Label Pilot-Study
- Source :
- Frontiers in Psychiatry, Vol 12 (2021), Frontiers in Psychiatry
- Publication Year :
- 2021
- Publisher :
- Frontiers Media S.A., 2021.
-
Abstract
- Background: Psychotic disorders are associated with high rates of comorbid substance use disorders. Use of cannabis rich in tetrahydrocannabinol (THC) is linked to an increased risk of psychosis, worsening of psychotic symptoms, and an adverse course of psychotic disorders. Previous studies suggest oral cannabidiol (CBD) as possible novel antipsychotic agent; however, no studies evaluated the effects of smoked CBD.Objective: The main aim of the study was to clarify the antipsychotic potential of CBD used as adjunctive therapy simulating a naturalistic setting. Our trial is the first study evaluating the effects of smoked CBD-cigarettes as adjunctive therapy for psychotic symptoms.Methods: A randomized, placebo-controlled open-label trial of cigarettes containing CBD-rich cannabis (THC < 1%) as adjunctive therapy to standard psychiatric treatment was conducted (ClinicalTrials.gov identifier NCT04700930). Primary outcomes were mean scores of Positive and Negative Syndrome Scale (PANSS), Brøset Violence Checklist, the Beck's Depression Inventory (BDI), the Subjective Well-Being Under Neuroleptics Scale short form (SWN-K), and antipsychotic medication equivalent doses. Outcomes were assessed after 4 weeks of acute treatment and long-term follow-up after discontinuation of CBD-cigarettes after 25 weeks. Participants were 31 acutely psychotic patients with tobacco use disorder and a mean age of 35.1 ± 10.58 years (71% male). Comorbid cannabis use was diagnosed in 51.6%.Results: A discontinuous multilevel model revealed no significant group differences for primary outcomes. After 4 weeks of acute treatment, mean PANSS and BDI decreased in both groups, while an increase of antipsychotic medication equivalent was observed in the placebo group.Conclusions: The presented findings might suggest an antipsychotic medication sparing effect of CBD-cigarettes as adjunctive treatment of acute psychosis. However, the low number of participants did not allow for further statistical analysis. Hence, a larger study sample and a more rigorous study design (blinding of the interventional product, fixed dosing regimen) may reveal different results.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04700930
- Subjects :
- cannabis
Psychosis
medicine.medical_specialty
medicine.medical_treatment
RC435-571
Antipsychotic Agent
Internal medicine
medicine
Antipsychotic
Psychiatry
Positive and Negative Syndrome Scale
biology
business.industry
antipsychotic agents
medicine.disease
biology.organism_classification
Clinical Trial
Discontinuation
schizophrenia
substance-related disorders
Psychiatry and Mental health
comorbidity
Schizophrenia
Adjunctive treatment
Cannabis
business
Subjects
Details
- Language :
- English
- ISSN :
- 16640640
- Volume :
- 12
- Database :
- OpenAIRE
- Journal :
- Frontiers in Psychiatry
- Accession number :
- edsair.doi.dedup.....df612d40fb6c80763065f0cd9554a688
- Full Text :
- https://doi.org/10.3389/fpsyt.2021.736822/full