Cannabinoids for Sickle Cell Disease (CRISP Trial)

Phase 2

Recruiting

Led By Susanna Curtis

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study at 8 weeks

Summary

This trial found that dronabinol, a medication used to treat pain and inflammation, was effective in treating sickle cell disease.

Who is the study for?

Adults over 18 with Sickle Cell Disease (SCD) who are not pregnant or nursing, and have been on a stable dose of pain medication for at least three months. Participants must not use cannabis regularly, have no history of psychosis or active substance abuse, and agree to avoid cannabis during the first 8 weeks of the study.

What is being tested?

The trial is testing Dronabinol, a cannabinoid medication, against a placebo to see if it can reduce pain and inflammation in people with SCD. The study randomly assigns participants to either the drug or placebo group without them knowing which one they're getting.

What are the potential side effects?

Potential side effects from Dronabinol may include altered mental state, dizziness, stomach issues, changes in appetite and mood swings. Side effects will be closely monitored by physicians due to interactions with other medications or medical conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

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

C-reactive protein

Columbia suicide severity rating scale

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DronabinolExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

A placebo comparator

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronabinol

2003

Completed Phase 4

~2080

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