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NCT07565974 · ClinicalTrials.gov registry record · Phase 2
THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia
A Phase 2 study, sponsored by Mayo Clinic.
- Not yet
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT07565974: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT07565974 is a Phase 2 study that has not yet begun recruiting, run by Mayo Clinic. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07565974, a Phase 2 study, has not yet begun recruiting, sponsored by Mayo Clinic.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance amongst cancer patients, often stemming from physical changes from tumor growth and surgery, side effects from supportive care and chemotherapy, and stress associated with the diagnosis. THC with or without CBD may improve insomnia symptoms and sleep quality.
Primary Outcome
The Insomnia Sleep Index (ISI) is a brief screening tool used to assess insomnia symptoms and sleep patterns over the past week. It consists of 7 questions answered on a scale of 0 (not al all) to 4 (not very much). Total scores range from 0-28 with higher scores indicating greater severity of clinical insomnia.
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Placebo Administration
- DRUG Single Agent Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
What is known before NCT07565974 opens enrollment
NCT07565974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT07565974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07565974 about?
NCT07565974 is a clinical study titled "THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia". This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance am...
What is the current status of trial NCT07565974?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2026-06-01. Estimated completion is 2027-09-01.
What interventions are being tested in trial NCT07565974?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Placebo Administration (DRUG), Single Agent Therapy (DRUG).
Who is sponsoring clinical trial NCT07565974?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07565974's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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