200
Participants
Start Date
February 22, 2022
Primary Completion Date
October 22, 2026
Study Completion Date
October 31, 2026
Placebo
"Placebo drug will be taken similarly to the THC and CBD and be matched to keep the trial blinded.~In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team.~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
Cannabidiol (CBD)
"Epidiolex doses will be 0.37 milliliter (mL) for seven days of treatment and then 0.75 mL two times a day (b.i.d) for the remaining days of this treatment.~In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team.~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)
"Dronabinol Capsules doses will be 2.5 mg b.i.d. for seven days of treatment and then 5 mg b.i.d. for the remaining days of this treatment.~In the event that 2.5 mg capsules of dronabinal capsules become unavailable, an equivalent product will be issued to participants and the comparator and placebo arms will be correspondingly adjusted to preserve blinding. If a participant's dose is not well-tolerated, the participant may initiate dose reductions with the study team.~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
RECRUITING
University of Michigan, Ann Arbor
National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Steven E Harte, PhD
OTHER