Overview

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

Status:
Terminated
Trial end date:
2021-01-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yale University
Treatments:
Dronabinol
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.