NCT05335252

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
13mo left

Started Jun 2022

Longer than P75 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jun 2022Jun 2027

First Submitted

Initial submission to the registry

April 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

4.4 years

First QC Date

April 13, 2022

Last Update Submit

April 24, 2025

Conditions

Knee OsteoarthritisKnee InjuriesMeniscus TearSynovitis of KneeKnee Ligament InjuryChondral Injury of Left KneeChondral Injury of Right KneeLoose Body Knee

Keywords

Knee Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Count of number of hydrocodone/acetaminophen tablet consumed

    up to 7 days post-surgery

Secondary Outcomes (4)

  • Pain Visual Analog Scale (VAS)

    up to 7 days post-surgery

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference

    up to 21 days post-surgery

  • PROMIS Bank v2.0 - Pain Behavior

    up to 21 days post-surgery

  • PROMIS Bank v2.0 - Physical Function

    up to 21 days post-surgery

Study Arms (2)

Dronabinol

EXPERIMENTAL

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

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DronabinolDRUG

5mg 2x daily for 7 days

Also known as: Marinol
Dronabinol
PlaceboDRUG

1 caplet 2x daily for 7 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeKnee Injuries

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Vehniah K Tjong, MD

    Northwestern Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Shauver, MPH

CONTACT

312-472-6024melissa.shauver1@nm.org

Abbie P Bennett, MS

CONTACT

312-922-6024abbie.bennett@nm.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 19, 2022

Study Start

June 28, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

US(1)