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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04298528
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Colorado Joint Replacement
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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.

Arms & Interventions

Arms

Experimental: dronabinol

Placebo Comparator: placebo

Interventions

Drug: - Dronabinol

2.5mg 2 times a day for 30 days after total knee replacement

Other: - Placebo

2 times a day for 30 days after total knee replacement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Joint Replacement, Denver, Colorado

Status

Recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Site Contact

Roseann Johnson

[email protected]

303-260-2940