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

Yale University

Status and phase: Terminated; Phase 1

Conditions: Sickle Cell Disease

Treatments: Drug: Microcrystalline cellulose; Drug: Dronabinol 2.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03978156

2000021179

Details and patient eligibility

About

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).

Full description

The Primary Hypothesis is that such a study will be feasible as defined by subject adherence to study medication and study procedures and avoidance of other cannabinoid containing substances during the trial period as well as by ability to mask subjects and investigators to treatment assignment

Secondary hypotheses are:

Dronabinol will:

Reduce patient-reported pain interference Reduce patient-reported pain scores and change patient-reported pain quality. Reduce use of opioid pain medications. Improve patient-reported stiffness, nausea and vomiting, sleep, mood, anxiety, and social functioning.

Reduce markers of inflammation.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

Dronabinol, Then Placebo

Experimental group

Description:

Participants will take 2.5 mg of Dronabinol for 2 weeks, 1 week washout and then take 2 weeks of placebo (microcrystalline cellulos). Subjects will take up to 8 capsules daily of the treatment daily during each phase.

Treatment:

Drug: Dronabinol 2.5 MG

Drug: Microcrystalline cellulose

Placebo, Then Dronabinol

Experimental group

Description:

Participants will take placebo (microcrystalline cellulos) for 2 weeks, 1 week washout and then take 2.5 mg of Dronabinol for 2 weeks. Subjects will take up to 8 capsules daily of the treatment daily during each phase.

Treatment:

Drug: Dronabinol 2.5 MG

Drug: Microcrystalline cellulose