Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)

Endometriosis Clinical Trial

— DREAMLAND  

Official title:

Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670353
• Other study ID #: 2021/10765-0
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 3, 2023
• Est. completion date: August 20, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Omero B Poli-Neto, MD; PhD
• Phone: 551636022583
• Email: polineto[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: August 20, 2024
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with chronic pelvic pain secondary to endometriosis surgically treated, with refractory symptoms, and who are taking complementary hormone therapy;

• Women over 18 years of age who wish to participate in the clinical trial;

• Willingness to voluntarily participate in the study to accept randomization to either of the two treatment arms;

• Participating exclusively in this clinical trial during the study period;

• Possess a telephone (cell or landline) that may be available to receive daily calls throughout the study period;

• Signature of the Free and Informed Consent Term (TCLE) approved by the Local Research Ethics Committee.

Exclusion Criteria:

• Chronic, severe or uncompensated medical conditions, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled high blood pressure, lung disease such as asthma or other chronic obstructive pulmonary disease; hematological diseases, liver diseases, chronic kidney disease in advanced stage (grade 3, 4 and 5), metabolic disturbances and immunosuppression;

• Use of any medication with potential interaction with CBD/THC (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this medications;

• Inability to use oral medication;

• Pregnancy or lactation;

• History of alcohol or drug addiction;

• Smoking in the last three years;

• Marijuana use in the past three months or a lifetime history of dependence;

• Inability to cooperate with investigators due to cognitive impairment or mental status.

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Drug:
• Cannabis Derivatives
CBD 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
• Placebo
Placebo 10 mg (up-titrated until 150mg or adverse effects) daily for 9 weeks
• Hormonal Contraceptive Agents
All participants will be given hormonal contraceptive.

Locations

Country	Name	City	State
Brazil	Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo	Ribeirão Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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
Primary	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 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
Primary	Quantitative change in pain intensity	Absolute variation of pain intensity measured through visual analogue scale	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
Secondary	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).	Day 0, Day 63
Secondary	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.	Day 0, Day 63
Secondary	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.	Day 0, Day 63
Secondary	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.	Day 0, Day 63
Secondary	Alanine aminotransferase (ALT)	Change in ALT concentration in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Aspartate aminotransferase (AST)	Change in AST concentration in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Glucose	Change in glucose concentration (glycemia) in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Bilirubin	Change in bilirubin concentration in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Cannabidiol (CBD)	Change in CBD concentration in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Tetrahydrocannabinol (THC)	Change in THC concentration in plasma	Week 0, Week 1, Week 5, Week 9.
Secondary	Side effects	Occurrence of side effects over time during the study period (day 0-63)	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.