Clinical trial NCT05670353: Cannabidiol for the Treatment of Pelvic Pain in Endometriosis (DREAMLAND)
Official title: Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Endometriosis
Pelvic Pain
Keywords: Cannabis
Endometriosis
Pelvic Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with pain change of 30%
timeFrame: 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
measure: Proportion of patients with pain change of 50%
timeFrame: 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
measure: Quantitative change in pain intensity
timeFrame: 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 outcomes:
measure: Pain threshold change
timeFrame: Day 0, Day 63
measure: Central sensitization change
timeFrame: Day 0, Day 63
measure: Brief measure for assessing generalized anxiety disorder
timeFrame: Day 0, Day 63
measure: Measure of the degree of depression severity
timeFrame: Day 0, Day 63
measure: Alanine aminotransferase (ALT)
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Aspartate aminotransferase (AST)
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Glucose
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Bilirubin
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Cannabidiol (CBD)
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Tetrahydrocannabinol (THC)
timeFrame: Week 0, Week 1, Week 5, Week 9.
measure: Side effects
timeFrame: 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.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo
state: Sao Paulo
Study officials:
References: