Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite the proliferation of cannabis and cannabinoid products in recent years little research has been done to determine the impact of these products on womens health conditions including endometriosis This study is designed to assess the impact of a custom-formulated hemp-derived full-spectrum high-CBD product vs placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis
Detailed Description:
Despite recent increases in both medical and recreational cannabis use in the United States and globally little research has been conducted to determine the potential applications for womens health Endometriosis impacts approximately 10 of women of reproductive age an estimated 176 million individuals and is characterized by endometrial cells growing outside of the uterus resulting in severe pain chronic inflammation gastrointestinal symptoms infertility and often depression and anxiety WHO 2023 Existing treatment options are often limited in efficacy and may result in a variety of negative side effects Previous research has indicated that cannabinoids including cannabidiol CBD delta-9 tetrahydrocannabinol THC and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis especially the chronic pain associated with the condition
This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis Participants will complete 7 visits over 12 weeks 4 visits will be conducted in-person at McLean Hospital in Belmont MA and 3 visits will be conducted remotely Visits consist of clinical ratings assessments of conventional medication use quality of life measures and providing saliva urine and blood samples
This study is a double-blind crossover clinical trial of a high-CBD product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis Participants will complete 7 visits over 12 weeks 4 visits will be conducted in-person at McLean Hospital in Belmont MA and 3 visits will be conducted remotely Visits consist of clinical ratings assessments of conventional medication use quality of life measures and providing saliva urine and blood samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None