Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

NCT05519111 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GCO 22-1141K23HL151884
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Change in Patient Reported Measurement Outcome Information System (PROMIS) pain impact score. Total scale from 20-80, median of 50 and SD of 10. Higher score represent poorer health outcomes.

  end of study at 8 weeks

Secondary Outcomes (19)

• Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact

  end of study at 8 weeks

• Quality of Life Outcomes

  end of study at 8 weeks

• WBC with differential

  end of study at 8 weeks

• C-reactive protein (CRP)

  end of study at 8 weeks

• tryptase

  end of study at 8 weeks

Study Arms (2)

Dronabinol

EXPERIMENTAL

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.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

A placebo comparator

Drug: Placebo

Interventions

Dronabinol DRUG

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

Also known as: Marinol

Dronabinol

Placebo DRUG

placebo equivalent

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Susanna Curtis

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Curtis, MD, PhD

CONTACT

2036718154; susanna.curtis@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Dronabinol and placebo will be over-encapsulated so that neither participants nor investigators are aware of the subjects assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized 1:1 to dronabinol or placebo.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: April 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Specify Other Time FrameOn request.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Proposals should be directed to susanna.curtis@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (website tbd.)

Locations

US (1)