← Back to Search

Cannabinoid

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

Awards & highlights

CRISP Trial 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.Check my eligibility

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.See study design

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.

CRISP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Secondary outcome measures

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

C-reactive protein

Columbia suicide severity rating scale

+16 more

CRISP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,416 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,567 Total Patients Enrolled

Susanna CurtisPrincipal InvestigatorMOUNT SINAI HOSPITAL

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05519111 — Phase 2

Sickle Cell Disease Research Study Groups: Dronabinol, Placebo

Sickle Cell Disease Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT05519111 — Phase 2

Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519111 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the known risks of Dronabinol use?

"Dronabinol received a score of 2 out of 3 because, while there is evidence backing its safety, there is no data attesting to its efficacy."

Answered by AI

Are we still able to sign up for the trial?

"From what is published on clinicaltrials.gov, this trial is still in the process of recruiting patients. The first posting was on October 1st, 2022 and the most recent edit was done September 27th, 2022."

Answered by AI

How many individuals are part of this research project?

"Yes, active recruitment is ongoing for this clinical trial. The first posting was on 10/1/2022 and the most recent update was 9/27/2022. They are looking to enroll 60 patients from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Susanna Curtis 2022. "Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05519111.

All > Cannabis > Sickle Cell