Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05519111
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dronabinol — DRUG
    Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
  • Placebo — DRUG
    placebo equivalent

Study Details

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).

Key Dates

Start date
Apr 3, 2025
Status verified
Sep 2025
Primary completion
Apr 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Susanna Curtis, MD, PhD
[email protected]
Susanna Curtis (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Sickle cell disease
By research site
Mount Sinai Hospital· New York, NY

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