Weight Loss, Blood Sugar and Blood Lipid Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
THCV
Weight Loss and Therapeutic Metablic Effects of Tetrahydrocannabivarin (THCV) Impregnated Mucoadhesive Strips
1 other identifier
interventional
56
1 country
1
Brief Summary
The goal of this clinical trial is to compare the efficacy of two different daily doses of tetrahydrocannabivarin impregnated mouth strips in healthy non-diabetic obese adults. The main questions to answer are:
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is the low dose treatment superior to placebo for losing weight, abdominal girth, cholesterol levels and blood glucose levels?
- Is one dose better than the other dose? Participants will take either the low dose, high dose or placebo dose daily for ninety days and have physical measurements and blood tests obtained at the beginning and the end of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2022
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2022
CompletedFirst Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedOctober 10, 2022
October 1, 2022
4 months
October 3, 2022
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Weight Loss
Change in body weight measured in kilograms
90 days
Decreased abdominal girth
Change in abdominal girth measures in centimeters
90 days
Systolic and diastolic blood pressure
Changes in systolic and diastolic blood pressure
90 days
Secondary Outcomes (2)
Aspartate Aminotransferase (AST) changes
90 days
Alanine Transaminase (ALT) changes
90 days
Study Arms (3)
Single Dose
ACTIVE COMPARATOROnce daily mouth strip containing 8mg of THCV and 10mg of CBD
Double Dose
ACTIVE COMPARATOROnce daily mouth strip containing 16mg of THCV and 20mg of CBD
Placebo
PLACEBO COMPARATOROnce daily mouth strip containing nothing
Interventions
The subjects will take once daily oromucosal strip with intervention drug for 90 days.
The subjects will take once daily oromucosal strip with no drug on it for 90 days
Eligibility Criteria
You may qualify if:
- Adults who met the clinical criteria for obesity (BMI ≥ 30) without comorbid diabetes or cardiovascular disease were selected for this study.
You may not qualify if:
- Under age 18 BMI less than 30 presence of diabetes or cardiovascular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hair and Scalp Clinic
Clearwater, Florida, 33762, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The physician investigator, and all of the test subjects will be masked from knowing which intervention that they are receiving.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 10, 2022
Study Start
January 4, 2022
Primary Completion
May 4, 2022
Study Completion
May 4, 2022
Last Updated
October 10, 2022
Record last verified: 2022-10