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

University of Sao Paulo

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Pelvic Pain; Endometriosis

Treatments: Drug: Hormonal Contraceptive Agents; Drug: Placebo; Drug: Cannabis Derivatives

Study type: Interventional

Funder types: Other

Identifiers

NCT05670353

2021/10765-0

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Cannabis Derivatives

Experimental group

Description:

Cannabis Derivatives (98% CBD, 2% THC) 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. All patients will take hormonal contraceptives, preferably progestagen-only. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

Treatment:

Drug: Cannabis Derivatives

Drug: Hormonal Contraceptive Agents

Placebo

Placebo Comparator group

Description:

Placebo will be given at the same protocol described before. The bottle, label, color and density of the contents will be the same. All patients will take hormonal contraceptives, preferably progestagen-only. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of active treatment according to the same previous protocol. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

Treatment:

Drug: Placebo

Drug: Hormonal Contraceptive Agents