Dronabinol After Arthroscopic Surgery

NCT ID: NCT05335252

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dronabinol

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

Group Type EXPERIMENTAL

Dronabinol

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 caplet 2x daily for 7 days

Interventions

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Dronabinol

5mg 2x daily for 7 days

Intervention Type DRUG

Placebo

1 caplet 2x daily for 7 days

Intervention Type DRUG

Other Intervention Names

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Marinol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Vehniah Tjong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vehniah K Tjong, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Feinberg School of Medicine

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa J Shauver, MPH

Role: CONTACT

312-472-6024

Abbie P Bennett, MS

Role: CONTACT

312-922-6024

Facility Contacts

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Melissa J Shauver, MPH

Role: primary

3124726024

Abbie P Bennett, MS

Role: backup

312-922-6024

Other Identifiers

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STU00213383

Identifier Type: -

Identifier Source: org_study_id

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