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

Launched by UNIVERSITY OF SAO PAULO · Dec 20, 2022

Keywords

ClinConnect Summary

The DREAMLAND trial is studying the effects of a cannabis extract, specifically cannabidiol (CBD), for treating pelvic pain caused by endometriosis in women. This study is for women who have already tried hormonal treatments and surgery but are still experiencing pain. The goal is to find out if this cannabis extract is effective and safe for these patients.

To join the study, participants must be women over 18 years old who have chronic pelvic pain from endometriosis and are currently on hormone therapy. They need to be willing to randomly receive either the cannabis extract or a placebo (a substance with no active effect) during the trial. Participants should also have a phone available to receive daily calls throughout the study. It’s important to note that women with severe medical conditions, those who are pregnant or breastfeeding, or those with a history of substance dependence cannot participate. If you choose to take part, you will be closely monitored and supported throughout the trial, helping researchers understand if this treatment can improve your quality of life.

Gender

FEMALE

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.