Phase 2 Sickle Cell Disease Trial, Recruiting NCT05519111 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Sickle Cell Disease
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Phase 2 Sickle Cell Disease Trial, Recruiting

NCT05519111
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:

  • You must be older than 18 years of age
  • You must have been diagnosed with Sickle Cell Disease (SCD) in one of several specific forms (confirm with trial site if unsure which type you have)
  • Your pain must be affecting your daily life at a certain level, based on a specific pain questionnaire score (confirm with trial site)
  • If you are already taking a medication to manage your SCD (such as hydroxyurea, regular blood transfusions, or certain other treatments), you must have been on a stable dose for at least 3 months
  • If you use opioid pain medications at home, you must have been on a stable dose for at least 3 months
  • You must have had one urine drug test negative for cannabis within 30 days of joining the trial
  • You must be willing to completely stop using cannabis (including medical cannabis) during the first 8 weeks of the study
  • If you are a woman who could become pregnant, you must be willing to use an accepted form of birth control for the whole study (such as the pill, an implant, a patch, or other accepted methods)
  • You must be able to give your own consent to participate in the research

Who may not be able to join:

  • You cannot join if you have a known intolerance or bad reaction to dronabinol (a cannabis-based medicine) or marijuana
  • You cannot join if you have a history of a psychotic episode or psychosis, or if you are currently having thoughts of suicide
  • You cannot join if a doctor has determined that dronabinol is medically unsafe for you based on your other medications or health conditions
  • You cannot join if you are currently pregnant or breastfeeding
  • You cannot join if you use cannabis every single day
  • You cannot join if you have been diagnosed with an active substance use disorder

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: Susanna Curtis, MOUNT SINAI HOSPITAL

Phone: 2036718154

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
Registry
ClinicalTrials.gov
Start date
3 April 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patient Reported Measurement Outcome Information System (PROMIS) pain impact score

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