Knee OsteoarthritisPhase 3NCT05335252
Dronabinol After Arthroscopic Surgery
A Phase 3 study testing Dronabinol in people with Knee Osteoarthritis and Knee Injuries, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Injuries, Meniscus Tear
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
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.
- Conditions
- Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee
- Being tested
- Dronabinol, Placebo
- Keywords
- Knee Arthroscopy
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol
5mg 2x daily for 7 days
PlaceboDrug
1 caplet 2x daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Count of number of hydrocodone/acetaminophen tablet consumed
Measured: up to 7 days post-surgery
Secondary outcomes (4)
Pain Visual Analog Scale (VAS)
Scored from 0 (no pain) to 10 (worst possible pain)
Measured: up to 7 days post-surgery
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).
Measured: up to 21 days post-surgery
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).
Measured: up to 21 days post-surgery
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.
Measured: up to 21 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start28 Jun 2022
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vehniah Tjong, Northwestern University
- Investigators
- Vehniah K Tjong, MD, Principal investigator, Northwestern Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335252
- Sponsor's protocol ID
- STU00213383
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05335252
- Acronym / sponsor ID
- STU00213383
- Conditions
- Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee
- Keywords
- Knee Arthroscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: DronabinolPatients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
| Placebo | Placebo comparator | Drug: PlaceboPatients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: Marinol5mg 2x daily for 7 days | Drug | Dronabinol |
| Placebo1 caplet 2x daily for 7 days | Drug | Placebo |
Primary outcome
Opioid consumption
Time frame: up to 7 days post-surgery
Count of number of hydrocodone/acetaminophen tablet consumed
4 secondary outcomes
Pain Visual Analog Scale (VAS)
Time frame: up to 7 days post-surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
Time frame: up to 21 days post-surgery
PROMIS Bank v2.0 - Pain Behavior
Time frame: up to 21 days post-surgery
PROMIS Bank v2.0 - Physical Function
Time frame: up to 21 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vehniah K Tjong, MD principal investigator
Northwestern Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dronabinol in people with Knee Osteoarthritis and Knee Injuries, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: up to 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.