Could cannabis oil be a new key to chronic pain relief and stronger bones in women?

NCT ID NCT07783295

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This trial tests whether a daily oral cannabis extract with a 5:1 CBD-to-THC ratio can reduce chronic pain in women aged 45 to 80 who haven't found relief from standard treatments. Participants will receive either the cannabis extract or a placebo in a crossover design, allowing each person to experience both. The study measures pain intensity, quality of life, sleep, and bone health markers, including bone density and genetic factors. The goal is to see if this approach can improve pain and potentially offer insights into preventing osteoporosis.

What this could mean

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

Active substance
Full-spectrum cannabis extract with a 5:1 CBD to THC ratio, taken as an oral softgel capsule
What this could lead to
If successful, this could offer a new option for women with hard-to-treat chronic pain, potentially improving pain, sleep, and quality of life while also shedding light on bone health.
What could go wrong
This is a small, early-stage trial, and results may not apply to everyone. Cannabis can cause side effects like dizziness or drowsiness, and the pain-relief effect may not be better than placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

45 to 80 years

Sex

Female participants only

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: * Female sex, age 45 to 80 years * Moderate to severe chronic pain, defined as a pain score of at least 4 on a 0 to 10 Visual Analog Scale, persisting for more than 3 months * Documented inadequate response to at least 2 classes of analgesic treatments or non-pharmacological treatments * Willingness to abstain from smoked cannabis and non-study cannabinoid products during the study * Ability to understand the informed consent form and study questionnaires * Willingness and ability to attend scheduled visits and biological sample collections during the study follow-up period Exclusion Criteria: * Cognitive impairment that precludes understanding of the informed consent form or study questionnaires * Uncontrolled psychiatric condition, including uncontrolled psychotic disorder or bipolar disorder * Pregnancy, breastfeeding, or intention to become pregnant during the study * Current use of medicinal cannabis, smoked cannabis, or other cannabinoid products * Known hypersensitivity to cannabinoids or formulation excipients * Clinically significant hepatic impairment, defined as aspartate aminotransferase or alanine aminotransferase greater than 3 times the upper limit of normal, or severe heart failure classified as New York Heart Association class III or IV * History of substance use disorder that, in the investigator's judgment, may interfere with study participation * Use of medications that may interfere with bone metabolism, including bisphosphonates, systemic corticosteroids, or sex hormones, within 6 months before enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Projeto Shalom

    São Paulo, São Paulo, 09130-040, Brazil

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