NCT03978156.

Trial name or title	Dronabinol for pain and inflammation in adults living with sickle cell disease
Methods	Allocation: randomized Controlled: placebo Blinding: double‐blind Arm: 2 crossover Centre: single Study duration: June 2019 (recruiting). Estimated completion June 2020.
Participants	Inclusion criteria: adults over 18 clinical diagnosis of SCD; baseline score <60 ACQ‐Me 7‐day pain domain Exclusion criteria: intolerance to dronabinol, sesame oil, or marijuana; psychiatric disorder; concomitant medical condition; pregnant Baseline characteristics N: 30 Gender: female and male Ages: 18 years or older Setting and location: Yale New Haven Hospital, USA
Interventions	Treatment group: 2.5 mg dronabinol oral tablet (titrated to 10 mg twice daily) Control group: placebo oral tablet
Outcomes	Primary outcomes Feasibility Adherence to study medication and study procedures Avoidance of other cannabinoid substances Secondary outcomes Patient reported 7‐day pain interference (Adult Sickle Cell Quality of Life Measurement Information System ASCQ‐Me) Patient reported emotional impact (Adult Sickle Cell Quality of Life Measurement Information System ASCQ‐Me) Patient reported sleep impact (Adult Sickle Cell Quality of Life Measurement Information System ASCQ‐Me) Patient reported stiffness impact (Adult Sickle Cell Quality of Life Measurement Information System ASCQ‐Me) Patient reported social functioning (Adult Sickle Cell Quality of Life Measurement Information System ASCQ‐Me) Pain severity (Numerical Rating Scale 0‐10) Nociceptive Pain Severity (Patient Reported Outcomes Measurement Information System PROMIS) Neuropathic Pain Severity (Patient Reported Outcomes Measurement Information System PROMIS) Gastrointestinal Nausea short form (Patient Reported Outcomes Measurement Information System PROMIS) Emotional distress anxiety 8a (Patient Reported Outcomes Measurement Information System PROMIS) Opioid utilization Markers of inflammation: white blood cell count, C‐reactive protein, serum tryptase, serum pro‐inflammatory cytokines, serum measure of Substance P
Starting date	6 June 2019
Contact information	Susanna Curtis, Yale New Haven Hospital Smilow Cancer Centre, New Haven, Connecticut, 06510, USA. Yale University School of Medicine Oncology Section. Email: susanna.curtis@yale.edu
Notes

mg: milligrams; ml: millilitres; N: number of participants; SCD: sickle cell disease; VAS: visual analogue scale