Last updated: November 27, 2023
Sponsor: CapSoil
Overall Status: Active - Recruiting
Phase
1
Condition
N/ATreatment
THC/CBD oil
THC/CBD S.E powder
Clinical Study ID
NCT06149988
V1022022
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must be 21-65 years old.
- Subjects must have a signed study informed consent before any procedure.
- Subjects must have a cannabis license as detailed at procedure No. 106 of the IMC-GCO , license will be issued and approved by PI at screening visit after signing oninformed consent.
- Female subjects must be of non-childbearing potential or, if of childbearingpotential, must have a negative urine pregnancy test at screening, visit 1 and visit
Exclusion
Exclusion Criteria:
- A history of allergic reactions attributed to compounds of similar chemical orbiologic composition to THC/CBD.
- Has an underlying medical condition that would preclude study participation.
- Chronic use of medications for underlying medical conditions.
- Use of any medications within 24 hours prior to treatment visit.
- Is currently participating in another study of an investigational agent/medicaldevice.
- Has known psychiatric or substance abuse disorders that would interfere withparticipating in the study.
- Patients who previously suffered from dysfunction of the: liver, kidneys, heart, bloodvessels and immune system (such as transplant recipients or patients undergoingchemotherapy).
- Patients who previously suffered from depression or anxiety.
- Medical history of high blood pressure, low blood pressure or diabetes.
- Patients who experience difficulties in performing daily activities.
- Current cannabis use or positive THC urine test results.
- Pregnant or lactating female subjects
Study Design
Total Participants: 14
Treatment Group(s): 2
Primary Treatment: THC/CBD oil
Phase: 1
Study Start date:
August 27, 2023
Estimated Completion Date:
February 01, 2024
Connect with a study center
Laniado Hospital
Netanya, 42150
IsraelActive - Recruiting
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