The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.
The Dreamland study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single-site superiority trial of oral cannabis extract (CBD). CBD will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. Dose up-titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of CBD according to the same previous protocol. This research intends to : 1. Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women. 2. Assess whether the daily use of CBD, for nine weeks, will modify pain threshold. 3. Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms. 4. Assess the possible adverse effects of using CBD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
CBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
Placebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
All participants will be given hormonal contraceptive.
Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil
Proportion of patients with pain change of 30%
Proportion of women with at least 30% of change in pain intensity. Pain intensity measured through visual analogue scale.
Time frame: Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year
Proportion of patients with pain change of 50%
Proportion of women with at least 50% of change in pain intensity. Pain intensity measured through visual analogue scale.
Time frame: Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year
Quantitative change in pain intensity
Absolute variation of pain intensity measured through visual analogue scale
Time frame: Time points for assess: Week 1, Week 3, Week 4, Week 5, Week 7, Week 8, Week 9; Data will be reported through study completion, an average of 1 year
Pain threshold change
Changes in the thermal peripheral pain thresholds: the range of temperatures at which a participant begins to perceive heat as painful: comparison between the beginning (day 0) and the end of the protocol (day 63).
Time frame: Day 0, Day 63
Central sensitization change
Changes in the score from Central Sensitization Inventory between the beginning (day 0) and the end of the protocol (day 63). Total scores ranging from 0-100. Higher scores mean a worse outcome. Score higher than 40 suggest central sensitization.
Time frame: Day 0, Day 63
Brief measure for assessing generalized anxiety disorder
Changes in the score from Generalized Anxiety Disorder (GAD7) scale between the beginning (day 0) and the end of the protocol (day 63). Total scores ranging from 0-21. Higher scores mean a worse outcome. Scores higher than 10 suggest generalized anxiety disorder.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0, Day 63
Measure of the degree of depression severity
Changes of scores for depressive symptoms over time during the study period (day 0-63) using Patient ́s Health Questionnaire-9 (PHQ-9). Total scores ranging from 0-27. Higher scores mean a worse outcome. Scores less than or equal to 4 suggest minimal depression.
Time frame: Day 0, Day 63
Alanine aminotransferase (ALT)
Change in ALT concentration in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Aspartate aminotransferase (AST)
Change in AST concentration in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Glucose
Change in glucose concentration (glycemia) in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Bilirubin
Change in bilirubin concentration in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Cannabidiol (CBD)
Change in CBD concentration in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Tetrahydrocannabinol (THC)
Change in THC concentration in plasma
Time frame: Week 0, Week 1, Week 5, Week 9.
Side effects
Occurrence of side effects over time during the study period (day 0-63)
Time frame: Week 0, Week 1 (Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7), Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9. Participants will be able to establish contact with a team doctor especially to report side effects.