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Can cannabis ease suffering in seriously ill kids? small study aims to find out

NCT ID NCT05615389

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study will test whether medicinal cannabis can help ease symptoms like pain, muscle spasms, and gut problems in 10 children (ages 6 months to 21 years) who are receiving palliative care for non-cancer conditions. The study focuses on whether the approach is practical and acceptable to families, not on proving the drug works. Children will be randomly assigned to one of two cannabis oils, and neither they nor the researchers will know which one they receive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medicinal cannabis (C12T12 Ruby Balanced Oil and C20T5 oil)
What this could lead to
If this study shows the approach is feasible, it could lead to a larger trial testing whether medicinal cannabis helps ease pain, muscle spasms, or gut problems in children receiving palliative care.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply to all children. It is designed to test feasibility, not effectiveness, so it may not show clear symptom benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females aged 6 months to 21 years of age; 2. Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition; 3. Pain, dystonia and/or gut dysfunction parent-rated symptom score above threshold, defined by rating on the relevant revised Memorial Symptom Assessment Scale (MSAS) question(s) of: 1. Frequency: "Frequently" or "Almost Constantly", AND 2. Severity: "Moderate", "Severe", or "Very Severe", AND 3. Distress: "Quite a bit", or "Very much"; 4. No changes in medication or other interventions in the two weeks prior to randomization; 5. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator; 6. Agrees not to drive for the duration of the study. Exclusion Criteria: 1. Non-English speaking parents. 2. Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis. 3. Taking medications which are known to interact with medicinal cannabis: warfarin, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day. 4. Abnormal liver function tests defined as ALT \> 3 x ULN 5. Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening 6. Pregnant or intending to become pregnant during the study, or breastfeeding. 7. History of clinically significant suicidal thoughts in the prior 12 months. 8. Life expectancy less than 3 months in the opinion of the investigators 9. Allergy to any of the components in the investigatory products (eg sunflower oil) 10. Diagnosis of a malignant condition

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As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Royal Children's Hospital / Murdoch Children's Research Institute

    RECRUITING

    Parkville, Victoria, 3052, Australia

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