166
Participants
Start Date
March 25, 2022
Primary Completion Date
August 30, 2027
Study Completion Date
August 30, 2027
Cannabidiol (CBD)
"Epidiolex® dose will be 0.5 mL (50 mg) twice daily during the first seven days of active treatment (half of full anticipated dose), followed by 1 mL (100 mg) twice daily for the remainder of the treatment interval (full dose). If the full dose (100 mg twice daily) is not tolerated by participants, they will have the option of going down to the original half-dose (50 mg twice daily).~Participants who go back to the half-dose of Cannabidiol (50 mg twice daily) also have the option to request once-per-day dosing with study drug taken at preferred time of day. Participants who request once-per-day dosing will not exceed a total daily dose 100 mg Cannabidiol per day. Participants who are tolerating the full-dose of medication (Cannabidiol 100 mg twice daily) will not be allowed to combine these doses into one daily dose."
Tetrahydrocannabinol (THC)
"Dronabinol dose will be 2.5 mg twice daily during the first seven days of active treatment (half of full anticipated dose), followed by 5 mg twice daily for the remainder of the treatment interval (full dose). If the full dose (5 mg twice daily) is not tolerated by participants, they will have the option of going down to the original half-dose (2.5 mg twice daily).~Participants who go back to the half-dose of Dronabinol (2.5 mg twice daily) also have the option to request once-per-day dosing with study drug taken at preferred time of day. Participants who request once-per-day dosing will not exceed a total daily dose 5 mg Dronabinol per day. Participants who are tolerating the full-dose of medication (Dronabinol 5 mg BID) will not be allowed to combine these doses into one daily dose."
Placebo CBD
Placebo solution will be taken twice per day, using the same dosing regimen as described for Epidiolex®.
Placebo THC
Placebo capsules will be taken twice per day in the same schedule and manner as active dronabinol.
RECRUITING
University of Michigan, Ann Arbor
National Center for Complementary and Integrative Health (NCCIH)
NIH
Tiffany J. Braley, MD, MS
OTHER