PruritusPhase 2CANNA-ITCHNCT06435299
Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
A Phase 2 study testing Cannabis oil in people with Pruritus, run by University Hospital, Brest at 6 sites in France.
Trial summary
Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- Cannabis oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Jan 2027to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
- Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
- Stable treatment (for treatment of the prurit) for at least 6 weeks
- Affiliated or benefiting of a social security
- Informed consent (personally dated and) signed by the participant or any representatives (impartial witness/trusted person)
Who cannot join
- Patients unable to consent.
- Patients refusing to participate in research.
- Patients under guardianship or conservatorship.
- Personal history of psychotic disorders.
- Severe hepatic impairment, defined as prothrombin level <50% or with predictive biological impairment.
- Moderate to severe renal impairment, with an estimated glomerular filtration rate ≤ 44 mL/min/1.73 m².
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- Severe cardiovascular or cerebrovascular disease, including history of myocardial infarction or stroke.
- Pregnant or breastfeeding women.
- Lack of understanding of questionnaires or inability to follow up.
- Women of childbearing potential unwilling to use appropriate contraception.
- Cannabinoid use outside the clinical trial
- Use of cannabis or its derivatives less than one week before inclusion
- History of hypersensitivity or allergy to any cannabinoid product.
- Allergy to nuts.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laurent MISERY, PU-PH contact
6 sites in 1 country
France6 sites
CHU Angers
Angers, France, 49000
YANNICK LE CORRE, MD, 02 41 35 34 19, yalecorre@chu-angers.fr
CHD Vendée
La Roche-sur-Yon, France, 85925
Carole POIRAUD, MD, 02 51 44 61 83, Carole.poiraud@ght85.fr
Groupe Hospitalier La Rochelle
La Rochelle, France, 17300
Cécile FRENARD, MD, 05 45 45 51 83, Cecile.frenard@ght-atlantique17.fr
CHU de Nantes
Nantes, France, 44093
Sebastien BARBAROT, MD-PHD, 02 40 08 40 86, sebastien.barbarot@chu-nantes.fr
CHU de Poitiers
Poitiers, France, 86000
Ewa HAINAUT, MD, 05 49 44 44 59, Ewa.HAINAUT@chu-poitiers.fr
CHRU de Tours
Tours, France, 37044
Laurent MACHET, MD-PHD, 02 47 47 87 73, machet@univ-tours.fr
About this study
Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.
Recent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.
Read more
Preclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.
Therefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.
- Conditions
- Pruritus
- Being tested
- Cannabis oil, Placebo
- Keywords
- itching, THC, CBD
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis oilDrug
Patients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
PlaceboDrug
Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
| Study group | Role | What they receive |
|---|---|---|
| Cannabis oil | Experimental | CBD:THC oil 50mg/mL arm :
An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say then only 0.1 per day , up to 1 ml/day maximum.
If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks. Receives: Drug: Cannabis oil |
| PLACEBO | Placebo comparator | Placebo arm :
An auto-titration phase will take place during the first 14 days of treatment with the same modalities as experimental group If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WI-NRS change
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
Measured: Week 0
WI-NRS change
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
Measured: Week 6
Secondary outcomes (18)
WI-NRS change from W0 to W2
- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2
Measured: Week 0
WI-NRS change from W0 to W2
- Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2
Measured: Week 2
WI-NRS change from W2 to W6
Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.
Measured: Week 2
WI-NRS change from W2 to W6
Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from week 2 to week 6.
Measured: Week 6
ItchyQoL change from W0 to W2
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
Measured: Week 0
ItchyQoL change from W0 to W2
- Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
Measured: Week 2
ItchyQoL change from W2 to W6
- Percent change in ItchyQoL score from Week 2 visit to week 6 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
Measured: Week 2
ItchyQoL change from W2 to W6
- Change in ItchyQoL score from Week 2 visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
Measured: Week 6
Chronic Itch Burden Scale change from W0 to W2
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
Measured: Week 0
Chronic Itch Burden Scale change from W0 to W2
- Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
Measured: Week 2
Chronic Itch Burden Scale change from W2 to W6
- Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching)
Measured: Week 2
Chronic Itch Burden Scale change from W2 to W6
- Percent change in Chronic Itch Burden Scale - 10 from Week 2 visit to week 6 (10 questions rated from "Not at all" to "Very much" on patient itching)
Measured: Week 6
Treatment adverse events
- Incidence and severity of treatment-emergent adverse events.
Measured: Week 0
Treatment adverse events
- Incidence and severity of treatment-emergent adverse events.
Measured: Week 2
Treatment adverse events
- Incidence and severity of treatment-emergent adverse events.
Measured: Week 4
Treatment adverse events
- Incidence and severity of treatment-emergent adverse events.
Measured: Week 6
Treatment adverse events
- Incidence and severity of treatment-emergent adverse events.
Measured: Week 8
Treatment Observance Rate
- Number of observant patients (YES/NO) in both arms: Observance (defined as YES) is considered as taking at least one dose of treatment per day over the W0 - W6 period.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435299
- Sponsor's protocol ID
- 29BRC23.0164
- Acronym
- CANNA-ITCH
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06435299
- Acronym / sponsor ID
- CANNA-ITCH / 29BRC23.0164
- Conditions
- Pruritus
- Keywords
- itching, THC, CBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.
Recent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.
Preclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.
Therefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Cannabis oil | Experimental | Drug: Cannabis oilCBD:THC oil 50mg/mL arm : An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say then only 0.1 per day , up to 1 ml/day maximum. If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks. |
| PLACEBO | Placebo comparator | Drug: PlaceboPlacebo arm : An auto-titration phase will take place during the first 14 days of treatment with the same modalities as experimental group If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised. After initial titration, the dose will then be maintained for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
- Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
- Stable treatment (for treatment of the prurit) for at least 6 weeks
- Affiliated or benefiting of a social security
Key exclusion criteria (14 listed)
- Patients unable to consent.
- Patients refusing to participate in research.
- Patients under guardianship or conservatorship.
- Personal history of psychotic disorders.
- Severe hepatic impairment, defined as prothrombin level <50% or with predictive biological impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis oilPatients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2) | Drug | Cannabis oil |
| PlaceboPatients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2) | Drug | PLACEBO |
Primary outcome
WI-NRS change
Time frame: Week 0
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
WI-NRS change
Time frame: Week 6
Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
18 secondary outcomes
WI-NRS change from W0 to W2
Time frame: Week 0
WI-NRS change from W0 to W2
Time frame: Week 2
WI-NRS change from W2 to W6
Time frame: Week 2
WI-NRS change from W2 to W6
Time frame: Week 6
ItchyQoL change from W0 to W2
Time frame: Week 0
ItchyQoL change from W0 to W2
Time frame: Week 2
ItchyQoL change from W2 to W6
Time frame: Week 2
ItchyQoL change from W2 to W6
Time frame: Week 6
Chronic Itch Burden Scale change from W0 to W2
Time frame: Week 0
Chronic Itch Burden Scale change from W0 to W2
Time frame: Week 2
Chronic Itch Burden Scale change from W2 to W6
Time frame: Week 2
Chronic Itch Burden Scale change from W2 to W6
Time frame: Week 6
Treatment adverse events
Time frame: Week 0
Treatment adverse events
Time frame: Week 2
Treatment adverse events
Time frame: Week 4
Treatment adverse events
Time frame: Week 6
Treatment adverse events
Time frame: Week 8
Treatment Observance Rate
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Topographical Distribution of Itch and Pain Receptors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent MISERY, PU-PH contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis oil in people with Pruritus, run by University Hospital, Brest at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent MISERY, PU-PH (laurent.misery@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WI-NRS change (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.