Skip to main content
. 2019 Nov 19;2019(11):CD012187. doi: 10.1002/14651858.CD012187.pub2

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