Dronabinol After Arthroscopic Surgery

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified April 2026 by Northwestern University
Sponsor
Northwestern University
Information Provided by (Responsible Party)
Vehniah Tjong
Clinicaltrials.gov Identifier
NCT05335252
Other Study ID Numbers:
STU00213383
First Submitted
April 12, 2022
First Posted
April 18, 2022
Last Update Posted
May 26, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Knee OsteoarthritisKnee InjuriesMeniscus TearSynovitis of KneeKnee Ligament InjuryChondral Injury of Left KneeChondral Injury of Right KneeLoose Body Knee
Drug: DronabinolDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment30 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleDronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Study Start DateJune 27, 2022
Actual Primary Completion Date5mos 4w from now
Actual Study Completion Date11mos 4w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Dronabinol
Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Drug: Dronabinol
5mg 2x daily for 7 days
Placebo
Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Drug: Placebo
1 caplet 2x daily for 7 days

Outcome Measures

Primary Outcome Measures
  1. Opioid consumption
    Count of number of hydrocodone/acetaminophen tablet consumed
Secondary Outcome Measures
  1. Pain Visual Analog Scale (VAS)
    Scored from 0 (no pain) to 10 (worst possible pain)
  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome).
  3. PROMIS Bank v2.0 - Pain Behavior
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome).
  4. PROMIS Bank v2.0 - Physical Function
    PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsNorthwestern University
Locations
Northwestern University Feinberg School of Medicine | Chicago Illinois, United States, 60611
Investigators
Principal Investigator: Vehniah K Tjong, MD, Northwestern Feinberg School of Medicine