Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

This study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

Key facts

Study ID

NCT03978156

Run by

Yale University

People needed

6

Starts

2019-07-26

Expected to finish

2021-01-01

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Age ≥18 years, able to understand and sign the informed consent form
• 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
• Willing to abstain from marijuana, medical and illicit, during study weeks 1 through 6.
• For patients currently receiving hydroxyurea and/or L-glutamine, on a stable dose(s) for at least 3 months
• For patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months

You may not qualify if…

• Known intolerance to dronabinol, sesame oil, or marijuana
• Patients with a diagnosis or medical history of any psychiatric disorder with psychosis
• Presence of any concomitant medical condition, or use of concomitant medication, that, in the Investigator's opinion, may place the subject at increased risk of side effects of dronabinol.
• Pregnant or nursing women
• If a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. We have not included a similar restriction for men as the current FDA approval includes no such restriction.

Where it is running

• Yale New Haven Hospital Smilow Cancer Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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