Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 22, 2022

Primary Completion Date

October 22, 2026

Study Completion Date

October 31, 2026

Conditions
Osteoarthritis, KneeOsteoarthritis of the Knee
Interventions
DRUG

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."

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."

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."

Trial Locations (1)

48109

RECRUITING

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Steven E Harte, PhD

OTHER