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Can cannabis ease diabetic nerve pain? new trial seeks answers

NCT ID NCT06490445

Symptom relief Sponsor: Syqe Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study tests whether inhaling medical cannabis three times a day can safely reduce pain in people with diabetic peripheral neuropathy. 122 adults will receive either a low, medium, or high dose of THC or a placebo using a special inhaler. The main goal is to see if pain scores improve after 15 weeks.

What this could mean

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

Active substance
Medical cannabis (THC) via Syqe inhaler
What this could lead to
If it works, this could offer a new, inhaled option for managing stubborn nerve pain from diabetes.
What could go wrong
This is a small, early-phase trial. The effect may be modest, and side effects like dizziness or drowsiness are possible. Results may not apply to all patients.

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

122 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 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. Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions. 2. Males and females aged between 18 (included) and 75 (included) years. 3. Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products. 4. Agree not to participate in other interventional clinical studies during participation in this study. 5. Treated with standard of care for DPNP, defined as either duloxetine, gabapentin or pregabalin as monotherapy or a combination of 2, or participants who discontinued the use of standard of care, or amitriptyline used for the management of pain related to DPNP, at least 3 months prior to screening. 6. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease. 7. Glycated hemoglobin (HbA1c) less than or equal to (\<=) 10% at screening. 8. Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive. 9. Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization. 10. Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the administration of study treatment on Day 1or be of non-child-bearing potential as defined in the protocol. 11. Participants of reproductive potential who are sexually active must use highly effective birth control methods. Exclusion Criteria: 1. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol at screening or randomization, ability to complete the study, or study assessments. 2. Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition. 3. Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments. 4. Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol. 5. Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. 6. Liver disease or liver injury as indicated by abnormal liver function tests at screening. 7. History or presence of impaired renal function at screening 8. Presence of significant pulmonary disease at screening 9. Ongoing respiratory infection. 10. History of acute coronary syndrome in the last 12 months; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure. 11. Concomitant clinically significant cardiac arrhythmias, examples, sustained ventricular tachycardia, and second or third degree atrioventricular block without a pacemaker, or any other relevant cardiac disease in the judgment of the investigator. 12. History of clinically significant electrocardiograms (ECG) abnormalities, or any of the following ECG abnormalities at screening or baseline: * PR greater than (\>) 200 milliseconds (msec) * QRS complex \>120 msec * Fridericia QT correction formula (QTcF) greater than (\>) 450 msec * History of familial long QT syndrome or known family history of ventricular arrythmia. * Acute ischemic changes. 13. History or presence of mental illness evidenced as defined in the protocol. 14. Abnormal neurological condition or abnormal neurological examination other than related to DPN as judged by the investigator at screening that impacts the assessment of study endpoints.

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Conditions

The condition(s) this trial relates to.

cannabis dependence diabetes mellitus diabetic neuropathy Respiratory Aspiration

As listed by the trial registrant

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

Diabetic peripheral neuropathic pain

Contacts and locations

Locations

  • Barzilai Medical center

    Ashkelon, 7830604, Israel

  • Beilinson hospital/ Petach Tikva

    Petah Tikva, 4941492, Israel

  • Berlin, Berlin

    Berlin, State of Berlin, 13187, Germany

  • Berlin, Berlin 4010

    Berlin, State of Berlin, 10629, Germany

  • Bnai Zion Medical Center

    Haifa, 3104802, Israel

  • Centrum Medyczne NEUROMED

    Bydgoszcz, 85-163, Poland

  • Centrum Medyczne Pratia Chojnice

    Chojnice, 89-600, Poland

  • Emeritus Research

    Camberwell, Victoria, 3124, Australia

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Hamburg, Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20253, Germany

  • Hannover, Lower Saxony

    Hanover, Lower Saxony, 30449, Germany

  • Heidelberg, Baden-Wuerttemberg

    Heidelberg, Baden-Wurttemberg, 69115, Germany

  • Innovate Clinical Research

    Waitara, New South Wales, 2077, Australia

  • Karlsruhe, Baden-Württemberg

    Karlsruhe, Baden-Wurttemberg, 76137, Germany

  • Katowice, Silesia

    Katowice, Silesian Voivodeship, 40-282, Poland

  • Katowice, Śląsk

    Katowice, Silesian Voivodeship, 40-748, Poland

  • Klinische Forschung Dresden GmbH

    Dresden, 3109601, Germany

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055, Germany

  • Osrodek Badan Klinicznych Neuro-Medic Clinic

    Katowice, 40-686, Poland

  • Ostrava, Ostrava City

    Ostrava, Ostrava City, 71000, Czechia

  • Plzen, Plzen City

    Pilsen, Plzen City, 30100, Czechia

  • Prague, Praha 12

    Prague, Prague, 12000, Czechia

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Reinfeld, Schleswig-Holstein

    Reinfeld, Schleswig-Holstein, 23858, Germany

  • Rychnov nad Kneznou, Hradec Kralove

    Rychnov nad Kněžnou, Hradec Kralove, 516 01, Czechia

  • Schwerin, Mecklenburg

    Schwerin, Mecklenburg, 19053, Germany

  • Sheba Medical center Hospital

    Ramat Gan, Tel Aviv, 5262100, Israel

  • Sochaczew, Mazowieckie

    Sochaczew, Masovian Voivodeship, 96-500, Poland

  • Swidnica, Dolnoslaskie

    Swidnica, Lower Silesian Voivodeship, 58-100, Poland

  • The Edith Wolfson Medical Center

    Holon, Tel Aviv, 58100, Israel

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Ulm, Baden-Württemberg

    Ulm, Baden-Wurttemberg, 89073, Germany

  • Warszawa, Mazowieckie

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Warszawa, Mazowieckie 7010

    Warsaw, Masovian Voivodeship, 02-677, Poland

  • Warszawa, Mazowieckie 7011

    Warsaw, Masovian Voivodeship, 01-018, Poland

  • Western Sydney University NICM Health Research Institute (NICM HRI)

    Westmead, New South Wales, 2145, Australia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Ziv Medical Center

    Safed, 13100, Israel

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