Impact of Daily Oral Cannabis Doses in Patients With Cancer

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Shanna Babalonis, PhD
Study ID
NCT06601218
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer
  • Cancers, Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral cannabis low THC — DRUG
    4 months daily dosing with oral cannabis low THC
  • Placebo Comparator — DRUG
    4 months of daily dosing with oral placebo
  • Oral cannabis high THC — DRUG
    4 months of daily dosing with oral cannabis with high THC
  • Oral cannabis THC/CBD — DRUG
    4 months of daily dosing with oral cannabis with THC and CBD

Study Details

This study will enroll patients with cancer and participants will be randomized to receive one dose of cannabis for approximately 4 months. There is a 3/4 (or 75%) chance that a participant will receive an active cannabis dose in the study. There is a 1/4 (or 25% chance) that a participant will receive a placebo dose (meaning a blank dose/no cannabis/no active drug). The goals of this study are to determine 1) the safety and tolerability of cannabis in individuals with cancer and 2) if cannabis can help with the side effects of cancer and cancer treatment - including nausea and vomiting, appetite, pain, sleep, and quality of life.

Key Dates

Start date
Jun 17, 2025
Status verified
Jun 2025
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Arm 1: Placebo Cannabis
    This arm will administer a placebo dose of oral cannabis (no active drug)
  • Active Comparator: Arm 2: Active Cannabis Low
    This arm will administer an active low dose of cannabis
  • Active Comparator: Arm 3: Active Cannabis High
    This arm will administer an active high dose of cannabis
  • Active Comparator: Arm 4: Active Cannabis (THC+CBD)
    This arm will administer an active dose of cannabis (THC+CBD)

Primary Outcome Measure

Percent of participants that withdraw from the study or are removed due to adverse events [ Time Frame: 5.5 months (includes 2 week no-drug baseline, 4 months of daily dosing, 1 month of no-drug follow-up) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40508
Paul Nuzzo, MA
[email protected]
859-323-0002

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By research site
University of Kentucky· Lexington, KY

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