Clinical trial NCT05519111: Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Official title: Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sickle Cell Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to dronabinol or placebo.
Primary purpose: SUPPORTIVE_CARE

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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Patient Reported Measurement Outcome Information System (PROMIS) pain impact score
timeFrame: end of study at 8 weeks
Secondary outcomes:
measure: Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact
timeFrame: end of study at 8 weeks
measure: Quality of Life Outcomes
timeFrame: end of study at 8 weeks
measure: WBC with differential
timeFrame: end of study at 8 weeks
measure: C-reactive protein (CRP)
timeFrame: end of study at 8 weeks
measure: tryptase
timeFrame: end of study at 8 weeks
measure: substance P
timeFrame: end of study at 8 weeks
measure: Vascular cell adhesion protein 1 (VCAM-1)
timeFrame: end of study at 8 weeks
measure: cytokine IL1a
timeFrame: end of study at 8 weeks
measure: cytokine IL1b
timeFrame: end of study at 8 weeks
measure: cytokine IL6
timeFrame: end of study at 8 weeks
measure: cytokine IL4
timeFrame: end of study at 8 weeks
measure: cytokine IL10
timeFrame: end of study at 8 weeks
measure: tumor necrosis factor alpha (TNFα).
timeFrame: end of study at 8 weeks
measure: PROMIS domains
timeFrame: end of study at 8 weeks
measure: Columbia suicide severity rating scale
timeFrame: end of study at 8 weeks
measure: Prodromal questionnaire brief version (PQ-B)
timeFrame: end of study at 8 weeks
measure: PROMIS domain for neuropathic pain quality
timeFrame: end of study at 8 weeks
measure: PROMIS domain for nociceptive pain quality
timeFrame: end of study at 8 weeks
measure: The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
timeFrame: end of study at 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Susanna Curtis
role: PRINCIPAL_INVESTIGATOR
References: