Recruiting
Phase 2

Cannabinoids

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05519111

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dronabinol

Placebo

Study Details

Brief summary:

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

Conditions

Sickle Cell Disease

Study ID

NCT05519111

Start date

Apr 3, 2025

Status verified date

Sep, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • Age >18 years
  • Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
  • Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
  • If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months
  • If using opioids for pain at home, on stable dose for at least 3 months
  • One urine toxicology negative for cannabinoids within 30 days of randomization
  • No known intolerance to dronabinol, or marijuana
  • No history of psychotic episode, psychosis, or active suicidality
  • No contraindication to dronabinol with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
  • Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8
  • Not pregnant or nursing
  • If a woman capable of becoming pregnant, willing to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception, medroxyprogesterone, contraceptive implants or patch, surgical sterilization, total abstinence.
  • Able to consent for research
  • No daily cannabis use
  • No diagnosis of active substance use disorder

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Dronabinol

BID for 8 weeks. Dosage will be individualized per patient. In days 1-4 of the study each patient will be titrated from 5mg bid to a minimum dose of 2.5 mg bid to a maximum dose of 10 mg bid depending on patient preference.

placebo comparator: Placebo

A placebo comparator

Interventions

Dronabinol

Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)

Placebo

placebo equivalent

Primary outcome measure

  • Patient Reported Measurement Outcome Information System (PROMIS) pain impact score [ Time Frame: end of study at 8 weeks ]

Central Contacts and Locations

Central contacts

Susanna Curtis, MD, PhD

2036718154susanna.curtis@mssm.edu

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Susanna Curtis, MD, PhD

susanna.curtis@mssm.edu

Principal Investigator:

Susanna Curtis

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-10-02.