Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis

Endometriosis Clinical Trial

— EdomTHC  

Official title:

Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03875261
• Other study ID #: 2018-004378-92
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: March 2019
• Source: Hospital Clinic of Barcelona
• Contact: Christian Dursteler, MD
• Phone: +34.93.227.54.00
• Email: dursteler[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women between the ages of 18 and 40.

• Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.

• Pain with a score of 4 or more on a numerical visual scale of 11 levels (EVN 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain).

• Women of childbearing age * should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it.

• Acceptance of participation in the study by signing the informed consent.

Exclusion Criteria:

• Patients previously submitted to open abdominal surgery.

• History of cancer.

• Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.

• Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.

• Current breastfeeding.

• Use of hormonal treatment (combined oral contraception, progestin in the 3 months prior to the study, GNRH analogs in the 6 months prior to the start of the study).

• Use of other analgesics different from those allowed in the study.

• Recreational or pharmacological use of cannabinoids.

• Hypersensitivity to cannabinoids or any of the exceptions.

• Known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders.

• Patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures.

• Patients who use concomitant potent enzyme inducers of CYP3A4, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort.

Related Conditions & MeSH terms

• Endometriosis
• Hyperalgesia

Intervention

Drug:
• Cannabinoid treatment
Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona	Catalonia

Sponsors (3)

Lead Sponsor	Collaborator
David Garcia Cinca	Dr. Christian Dursteler, Fundació Clínic per la Recerca Biomedica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure threshold in hypogastrium that induces pain	Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa	day 30 after treatment initiation
Secondary	Pressure threshold in dermatomes that induces pain	Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity.	baseline, day 15, day 30 and day 45
Secondary	Temperature threshold in dermatomes that induces pain	Umbral sensation versus thermal stimulus (cold heat) in anterior central L2 dermatomes, posterior central L2, and T1 of the dominant upper extremity. Measured in ºC.	baseline, day 15, day 30 and day 45
Secondary	Intensity of the general pain	Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)	baseline, day 15, day 30 and day 45
Secondary	Anxiety and depression combined scale	Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).	baseline, day 15, day 30 and day 45
Secondary	Quality of Life	Quality of Life measured through the EQ-5D-5L questionnaire.	baseline, day 15, day 30 and day 45
Secondary	Central sensitivity	Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.	baseline, day 15, day 30 and day 45
Secondary	Cognitive disorder measured by a list of words	Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III).	baseline, day 15, day 30 and day 45
Secondary	about sleep quality	Visual analogue scale 0-10 about sleep quality	baseline, day 15, day 30 and day 45