Dronabinol for Anemia, Sickle Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mount Sinai Hospital, New York, NY
Anemia, Sickle Cell+2 More
Dronabinol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Anemia, Sickle Cell

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anemia, Sickle Cell

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: end of study at 8 weeks

Week 8
Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact
C-reactive protein (CRP)
Columbia suicide severity rating scale
PROMIS domain for neuropathic pain quality
PROMIS domain for nociceptive pain quality
PROMIS domains
Patient Reported Measurement Outcome Information System (PROMIS) pain impact score
Prodromal questionnaire brief version (PQ-B)
Quality of Life Outcomes
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
Vascular cell adhesion protein 1 (VCAM-1)
WBC with differential
cytokine IL10
cytokine IL1a
cytokine IL1b
cytokine IL4
cytokine IL6
substance P
tryptase
tumor necrosis factor alpha (TNFα).

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Anemia, Sickle Cell

Trial Design

2 Treatment Groups

Dronabinol
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Dronabinol · Has Placebo Group · Phase 2

Dronabinol
Drug
Experimental Group · 1 Intervention: Dronabinol · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: end of study at 8 weeks
Closest Location: Mount Sinai Hospital · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2011First Recorded Clinical Trial
2 TrialsResearching Anemia, Sickle Cell
494 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,915,129 Total Patients Enrolled
148 Trials studying Anemia, Sickle Cell
46,463 Patients Enrolled for Anemia, Sickle Cell
Icahn School of Medicine at Mount SinaiLead Sponsor
761 Previous Clinical Trials
493,595 Total Patients Enrolled
4 Trials studying Anemia, Sickle Cell
75 Patients Enrolled for Anemia, Sickle Cell
Susanna CurtisPrincipal InvestigatorMOUNT SINAI HOSPITAL

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical diagnosis of SCD.
You have not used cannabis within the past 30 days.
You have a baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain.
You are willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.