Cannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients with pain change of 30%
研究概览
简要总结
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.
详细描述
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 :
- Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women.
- Assess whether the daily use of CBD, for nine weeks, will modify pain threshold.
- Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms.
- Assess the possible adverse effects of using CBD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Volunteers, administrative staff, laboratory technicians, doctors who will carry out the assessments, and statisticians will be blind to the treatment group and will not know about the group treatment information.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cannabis Derivatives
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.
干预措施: Cannabis Derivatives (Drug)
Cannabis Derivatives
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.
干预措施: Hormonal Contraceptive Agents (Drug)
Placebo
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.
干预措施: Placebo (Drug)
Placebo
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.
干预措施: Hormonal Contraceptive Agents (Drug)
结局指标
主要结局
Proportion of patients with pain change of 30%
时间窗: 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
Proportion of women with at least 30% of change in pain intensity. Pain intensity measured through visual analogue scale.
Proportion of patients with pain change of 50%
时间窗: 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
Proportion of women with at least 50% of change in pain intensity. Pain intensity measured through visual analogue scale.
Quantitative change in pain intensity
时间窗: 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
Absolute variation of pain intensity measured through visual analogue scale
次要结局
- Central sensitization change(Day 0, Day 63)
- Brief measure for assessing generalized anxiety disorder(Day 0, Day 63)
- Glucose(Week 0, Week 1, Week 5, Week 9.)
- Pain threshold change(Day 0, Day 63)
- Alanine aminotransferase (ALT)(Week 0, Week 1, Week 5, Week 9.)
- Aspartate aminotransferase (AST)(Week 0, Week 1, Week 5, Week 9.)
- Cannabidiol (CBD)(Week 0, Week 1, Week 5, Week 9.)
- Side effects(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.)
- Measure of the degree of depression severity(Day 0, Day 63)
- Tetrahydrocannabinol (THC)(Week 0, Week 1, Week 5, Week 9.)
- Bilirubin(Week 0, Week 1, Week 5, Week 9.)
研究者
Omero Benedicto Poli Neto
Prof. Dr.
University of Sao Paulo