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

NCT03978156 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 2000021179
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (4)

• Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence

  Feasibility will be defined by ability to mask patients and investigators to treatment assignment and adherence which will be defined in 3 ways.

  1 year

• Adherence

  Adherence to study drug will be assessed with weekly pill counts and urine toxicology.

  1 year

• Avoidance

  Avoidance of other cannabinoid containing substances will also be defined using urine toxicology once at the end of each treatment period and once at the end of the wash out period.

  7 weeks

• Adherence to other study proceedures

  Adherence to other study procedures will be defined as percent of visits attended, percent of urine and serum studies collected and percent of patient reported outcomes and daily pain severity and pain unpleasentness journals returned.

  7 weeks

Secondary Outcomes (17)

• Patient reported 7-day pain interference

  7 days

• Patient Pain Severity

  end of 2nd week

• Patient Pain Unpleasantness

  end of 2nd week

• PROMIS (Patient Reported Outcomes Measurement Information System) Nociceptive Pain Severity

  end of 2nd week

• PROMIS Neuropathic Pain Severity

  end of 2nd week

Study Arms (2)

Dronabinol, Then Placebo

EXPERIMENTAL

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.

Drug: Dronabinol 2.5 MG; Drug: Microcrystalline cellulose

Placebo, Then Dronabinol

EXPERIMENTAL

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.

Drug: Dronabinol 2.5 MG; Drug: Microcrystalline cellulose

Interventions

Dronabinol 2.5 MG DRUG

Subjects will take dronabinol daily during 2 week dosing period separated by a one week washout period.

Dronabinol, Then Placebo; Placebo, Then Dronabinol

Microcrystalline cellulose DRUG

Subjects will take placebo daily during 2 week dosing period separated by a one week washout period.

Also known as: Placebo

Dronabinol, Then Placebo; Placebo, Then Dronabinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital Smilow Cancer Center

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Curtis SA, Jhawar R, Bellis J, McCuskee S, Devine L, Roberts JD. A pilot study of dronabinol for the treatment of pain in sickle cell disease. Pilot Feasibility Stud. 2025 Nov 12;11(1):139. doi: 10.1186/s40814-025-01705-6.

  PMID: 41225660 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Dronabinol; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Susanna Curtis, MD

  Yale University School of Medicine Oncology Section

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double blind, cross-over study of dronabinol compared to placebo

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 6, 2019
• Study Start: July 26, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)