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Cannabidiol for acting out dreams

Researchers are testing cannabidiol, also called CBD, for a sleep condition associated with Parkinson's.

Testing a treatment or activity · Study reference: RBR-5fwhf7

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported date)
2017-08-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Ask the team who can join

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Read all the rules for taking part

Sex eligibility reported by registry: -

Inclusion criteria: Diagnosis of PD according to criteria of the London Brain Bank in stage 1-3 of the Hoehn and Yahr scale;Over 18 years of age;Diagnosis of RBD according to the criteria of the 3rd edition of the International Classification of Sleep Disorders (CIDS-3);With sufficient severity and frequency to indicate a symptomatic treatment, ie with a frequency of 2 or more episodes per week;That they agree to participate in the study. Exclusion criteria: In adjustment of antiparkinsonian medications; With diagnosis of dementia; Presenting significant hallucinations (score> 2 in the MDS-UPDRS psychosis item); Introducing delusions; With depression; Without a partner with whom you share your bedroom;With severe or decompensated systemic diseases;With probable mild TCSREM, with sporadic episodes and not clinically significant;Alcoholism or use of illicit drugs;Patients in stage 4-5 of the Hoehn and Yahr scale.
Full study name & original research details

Official study title

Canabidiol in treatment of REM behavior sleep disorder associated with Parkinson's disease- a double-blind placebo controlled clinical trial - CBD-RBD study: CannaBiDiol-Rem Behavior Disorder estudo

Short title used by the registry

Canabidiol in the treatment of sleep disorder associated with Parkinson's Disease

Original description

Intervention: It will be administered in patients with Parkinson's disease and REM sleep behavior disorder the drug called canabidiol(CBD) in progressive doses of 75 until 300mg for 12 weeks in 20 patients (group 1) at the same time will be administered the placebo in 20 patients (group 2) during the same time period. The placebo will consist of capsules containing corn oil.;Drug;C10.886.659.633.700;C10.886.659.633;C10.228.140.079.862.500 Primary outcome: 1-A reduction of at least 50% in the frequency of motor symptoms measured by the sleep diary after 12 weeks of intervention. ;A sleep diary will be used to report on the frequency of nocturnal movements. This questionnaire will be completed by the patient or caregivers daily during the baseline period and during the intervention phase that will have 12 consecutive weeks. A reduction of at least 50 percent of the violent nighttime movements is expected in comparison to the baseline period in those who used Canabidiol compared to the placebo group. Secondary outcome: 1-Improvement of the general quality of sleep through Pittsburgh sleep questionnaire; 2-Improvement of the Parkinson's Sleep Scale (PDSS).;The Pittsburgh Sleep Quality Scale will be used to report on subjective sleep quality of patients. The Pittsburgh questionnaire is used worldwide in sleep quality research, it consists of 19 items grouped into 7 major groups that assess duration, latency, sleep efficiency, and daytime complaints. Each group receives a score of 0-3 that is summed to compose a final score or PSQI-Pittsburgh Scale Questionnaire Index, which ranges from 0-21 points. Higher scores indicate poor sleep quality. The choice of such questionnaire was made because it is widely used and easy to apply. With a 5-point cutoff level, it reaches a sensitivity of 89.6% and specificity of 86.5% differentiating healthy individuals from patients with sleep complaints (""good sleeper / bad sleeper""). It will be applied at baseline and after 12 weeks of intervention. An improvement in sleep quality is expected in the cannabidiol group. Patients will also be evaluated through a sleep scale specially developed for PD and called PDSS (Parkinson's Disease Sleep Scale). It is a self-applicable scale consisting of fifteen items, each scoring from zero to four points. The total score ranges from zero (no sleep disturbance) to 60 points. It will be applied at baseline and after 12 weeks of intervention. An improvement in sleep quality in the PDSS group is expected in the cannabidiol group.

Conditions reported: Parkinson Disease; REM behavior sleep disorder;C10.886.659.633.700

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
It will be administered in patients with Parkinson's disease and REM sleep behavior disorder the drug called canabidiol(CBD) in progressive doses of 75 until 300mg for 12 weeks in 20 patients (group 1) at the same time will be administered the placebo in 20 patients (group 2) during the same time period. The placebo will consist of capsules containing corn oil.;Drug;C10.886.659.633.700;C10.886.659.633;C10.228.140.079.862.500
Phases
1-2
Sponsor
Universidade de Sao Paulo
Start date reported by registry
2017-08-01 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Carlos Almeida · 5516991751973 · acrmauri33@usp.br

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Brazil

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.