Dronabinol After Arthroscopic Surgery

Study Purpose

The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 18 years or older.
  • - Patient who will undergo arthroscopic surgery of the knee including, but not limited to, - Meniscectomy.
  • - Synovectomy.
  • - Chondroplasty.
  • - Loose body removal.

Exclusion Criteria:

  • - Patients under age 18 years.
  • - Patients who cannot provide consent.
  • - Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period.
  • - Patients with an allergy to any of the study drugs.
  • - Patient who are lactose-intolerant.
  • - Revision surgery.
  • - Open surgery.
  • - Comorbidities preventing surgery.
  • - Patients with a history of mania, depression, or schizophrenia.
  • - Patients taking any of the following drugs or supplements.
  • - Anticholinergic agents.
  • - Benzodiazepines.
  • - Central nervous system depressants.
  • - Droperidol.
  • - Hydroxyzine.
  • - Levomepromazine or methotrimeprazine.
  • - Monoamine oxidase inhibitors.
  • - Ritonavir.
  • - Selective serotonin reuptake inhibitors.
  • - Sympathomimetics.
  • - St. John's Wort.
  • - Current diagnosed alcohol or drug abuse.
  • - Patients who cannot or will not abide by the medication restrictions listed below.
Medication restrictions.
  • - Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period.
- Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen

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.

NCT05335252
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.

Northwestern University
Principal Investigator

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

Vehniah K Tjong, MD
Principal Investigator Affiliation Northwestern Feinberg School of Medicine
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.

Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee, Chondral Injury of Right Knee, Loose Body Knee
Arms & Interventions

Arms

Experimental: Dronabinol

Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Placebo Comparator: Placebo

Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Interventions

Drug: - Dronabinol

5mg 2x daily for 7 days

Drug: - Placebo

1 caplet 2x daily for 7 days

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.

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

Site Contact

Melissa J Shauver, MPH

[email protected]

312-472-6024