Phase 2 Rare Disease Trial, Recruiting NCT06099379 Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) Condition: Rare Disease
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Phase 2 Rare Disease Trial, Recruiting

NCT06099379
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 21 and 49 years of age (including those ages)
  • People who have used cannabis at least once in their life, but no more than three days in the past 30 days before joining
  • People who are able to sign a consent form agreeing to take part
  • People who are willing to follow the study's procedures and requirements
  • People whose lung function test result (measuring how much air can be breathed out in one second) is at or below 90% of the expected level
  • People who can communicate and understand English or French
  • Female participants who cannot become pregnant — either due to being postmenopausal (no periods for 12 months and aged 45 or older) or having had a documented surgical procedure such as tubal ligation, hysterectomy, or removal of both ovaries
  • Female participants who could become pregnant but have a negative pregnancy test at the start and follow-up visits, have no plans to become pregnant during the study, and agree to use an accepted form of birth control throughout the study

Who may not be able to join:

  • People with a serious medical condition that, in the study doctor's opinion, makes safe participation or giving fully informed consent impossible
  • People with a history of schizophrenia, schizoaffective disorder, or bipolar disorder, or who are currently experiencing acute psychosis, mania, or suicidal thoughts (as assessed by a standard psychiatric interview)
  • People with any other serious, unstable, or acute mental health condition that, in the study doctor's opinion, makes safe participation or giving fully informed consent impossible
  • People with known chronic liver disease, or whose liver enzyme levels (AST/ALT) are more than twice the normal upper limit at the screening visit
  • People with blood pressure higher than 130/80 mmHg
  • People with kidney disorders
  • People with bleeding disorders
  • People with a current moderate or severe substance use disorder (other than nicotine), as assessed by a standard clinical interview
  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • People with pending legal matters or other circumstances that, in the study doctor's opinion, might prevent them from completing the study
  • People who have taken any medication within 7 days before the experimental sessions that the study investigator believes may interact with cannabis
  • People who have taken part in another clinical study involving cannabis or cannabinoids within the 30 days before being assigned to a study group
  • People with a resting heart rate above 100 beats per minute
  • People with a body mass index (BMI — a measure of body weight relative to height) above 29.9
  • People with any significant abnormality found on a heart tracing (ECG) test at the screening visit

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Didier Jutras-Aswad, MD, MS, CRCHUM

Phone: 514-890-8000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Registry
ClinicalTrials.gov
Start date
27 June 2024
Est. completion
31 July 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Objective and subjective measures of cannabinoids effect

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov