Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai Hospital
RECRUITING
New York
Contact Information
Primary
Susanna Curtis, MD, PhD
susanna.curtis@mssm.edu
2036718154
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 60
Treatments
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
Sponsors
Leads: Icahn School of Medicine at Mount Sinai
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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