Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain (CRISP)

Mount Sinai Health System

Status and phase: Enrolling; Phase 2

Conditions: Sickle Cell Disease

Treatments: Drug: Placebo; Drug: Dronabinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05519111

GCO 22-1141

K23HL151884 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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).

Primary Objective: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain.

Secondary Objectives: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo.

To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Dronabinol

Experimental group

Description:

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.

Treatment:

Drug: Dronabinol

Placebo

Placebo Comparator group

Description:

A placebo comparator

Treatment:

Drug: Placebo