A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty (dronabinol)

Colorado Joint Replacement

Status and phase: Enrolling; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Drug: Dronabinol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04298528

1554107

Details and patient eligibility

About

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

Full description

Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

Enrollment: 460 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent from
• Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
• Male or Female
• Age 21-75
• Unilateral total knee arthroplasty at Colorado Joint Replacement
• All individuals will be screened for drug use (including cannabis) at their preoperative appointment
• Ability to take oral medication and be willing to adhere to the dronabinol regimen
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion criteria

• Narcotic use in the past 6 weeks
• Regular cannabis use in the past 3 months
• Major depression or anxiety disorders
• Documented psychiatric illness (e.g. bipolar, schizophrenia)
• Seizure disorder
• Current or previous history of drug and alcohol abuse
• Known allergic reactions to components of dronabinol
• Tobacco use in the past 90 days
• Treatment with another investigational drug
• Patients that cannot receive spinal anesthesia
• Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)
• Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups, including a placebo group

dronabinol

Experimental group

Description:

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Treatment:

Drug: Dronabinol

placebo

Placebo Comparator group

Description:

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Treatment:

Other: Placebo