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

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Mount Sinai Health System

Status and phase

Enrolling
Phase 2

Conditions

Sickle Cell Disease

Treatments

Drug: Dronabinol
Drug: Placebo

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

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

Trial contacts and locations

0

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Central trial contact

Susanna Curtis, MD, PhD

Data sourced from clinicaltrials.gov

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