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NCT06601218 · ClinicalTrials.gov registry record · Phase 1

Impact of Daily Oral Cannabis Doses in Patients With Cancer

A Phase 1 study of Cancer and Cancers, Pain, sponsored by Shanna Babalonis, PhD.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target
1
Study location

NCT06601218: Recruiting Phase 1 study of Cancer and Cancers, Pain, sponsored by Shanna Babalonis, PhD.

NCT06601218 is a Phase 1 study of Cancer and Cancers, Pain that is actively recruiting participants, run by Shanna Babalonis, PhD. The registered enrollment target is 80 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06601218, a Phase 1 study of Cancer and Cancers, Pain, is actively recruiting participants, sponsored by Shanna Babalonis, PhD.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

The percent of patients who elect to withdrawal from the study or removed by physician/investigators due AEs or safety concerns in each group will be measured and compared to the placebo group.

Conditions Studied

Interventions

  • DRUG Oral cannabis low THC
  • DRUG Placebo Comparator
  • DRUG Oral cannabis high THC
  • DRUG Oral cannabis THC/CBD

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-06-17
Est. Completion 2030-12-01
Phase Phase 1
Shanna Babalonis, PhD

6 total trials

What NCT06601218 shows while recruiting

NCT06601218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which Oral cannabis low THC is the first listed.

NCT06601218 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT06601218 about?

NCT06601218 is a clinical study titled "Impact of Daily Oral Cannabis Doses in Patients With Cancer". 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 rece...

What is the current status of trial NCT06601218?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-06-17. Estimated completion is 2030-12-01.

What conditions does trial NCT06601218 study?

This clinical trial studies the following conditions: Cancer, Cancers, Pain.

What interventions are being tested in trial NCT06601218?

The interventions under investigation include: Oral cannabis low THC (DRUG), Placebo Comparator (DRUG), Oral cannabis high THC (DRUG), Oral cannabis THC/CBD (DRUG).

Who is sponsoring clinical trial NCT06601218?

This trial is sponsored by Shanna Babalonis, PhD, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06601218 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06601218's enrollment target sits among peer trials

80 349th of 615 higher than 255 of 615 other Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06601218, the US trial registry maintained by the National Library of Medicine. NCT06601218 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.