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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up) for reporting.