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Cancer Vaccine
Oral Cannabis for Cancer
Lexington, KY
Phase 1
Waitlist Available
Led By Zin Myint, MD
Research Sponsored by Shanna Babalonis, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Negative urine drug screen for all illicit drugs and THC, CBD prior to randomization
Must not have
Current, regular use of cannabis/marijuana or THC-containing medications or cannabidiol or over-the-counter CBD oil
Cardiac conditions contraindicated for cannabis use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)
Summary
"This trial will include cancer patients who will be randomly assigned to receive either cannabis or a placebo for about 4 months. There is a 75% chance of receiving active cannabis and a 25%
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Who is the study for?
This trial is for cancer patients experiencing pain. Participants must be willing to take a daily oral dose of cannabis or placebo for about 4 months. They have a higher chance of receiving active cannabis than a placebo.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of different doses of oral cannabis (low THC, THC/CBD mix, high THC) compared to a placebo in managing cancer-related symptoms over approximately 4 months.See study design
What are the potential side effects?
Possible side effects include dizziness, dry mouth, feeling high, sleepiness, and changes in appetite. These are common with cannabis use but can vary based on individual tolerance and the specific dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My drug screen for illegal substances and cannabis products was negative.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I regularly use cannabis, THC medications, or CBD oil.
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I have heart conditions that make cannabis use unsafe for me.
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My cancer is related to HPV.
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I have a history of seizures or epilepsy.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of participants that withdraw from the study or are removed due to adverse events
Secondary study objectives
Cancer Burden Assessment
Change in Heart Rate
Change in O2 saturation
+1 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Arm 2: Active Cannabis LowActive Control1 Intervention
This arm will administer an active low dose of cannabis
Group II: Arm 4: Active Cannabis (THC+CBD)Active Control1 Intervention
This arm will administer an active dose of cannabis (THC+CBD)
Group III: Arm 3: Active Cannabis HighActive Control1 Intervention
This arm will administer an active high dose of cannabis
Group IV: Arm 1: Placebo CannabisPlacebo Group1 Intervention
This arm will administer a placebo dose of oral cannabis (no active drug)
Find a Location
Closest Location:University of Kentucky· Lexington, KY
Who is running the clinical trial?
Shanna Babalonis, PhDLead Sponsor
4 Previous Clinical Trials
56 Total Patients Enrolled
Zin Myint, MDPrincipal InvestigatorUniversity of Kentucky College of Medicine
1 Previous Clinical Trials
30 Total Patients Enrolled