Knee OsteoarthritisPhase 2NCT03098563

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

A Phase 2 study testing Blinded study medication in people with Knee Osteoarthritis, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Blinded study medication
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2017to 27 Nov 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of knee osteoarthritis
Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
Medically cleared to take study medications
Are not pregnant or breast feeding
Willing to comply with the study protocol.

Who cannot join

Pain other than Knee Osteoarthritis
Taking opioids for pain
Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
Known allergy to the blinded study medications

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins
Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients

This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

Read the detailed description

This study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. Subjects will complete two screening sessions before completing four study sessions that will occur once weekly. Participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.

Conditions: Knee Osteoarthritis
Being tested: Blinded study medication
Keywords: Clinical Trial, Phase II
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blinded study medicationDrug
Also called stimulants, benzodiazepines, opioids, cannabinoids, over the counter (OTC) medications, placebo
Blinded study medication: This is a double-blind within-subject Phase II trial. Study medications will remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications or placebo (sugar pill). All subjects will serve as their own control. Study medication administration will be randomized within each participant.

Study groups in NCT03098563
Study group	Role	What they receive
Arm 1	Experimental	Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Receives: Drug: Blinded study medication
Arm 2	Experimental	Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Receives: Drug: Blinded study medication
Arm 3	Experimental	Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Receives: Drug: Blinded study medication
Arm 4	Experimental	Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit. Receives: Drug: Blinded study medication

What is being measured

The primary outcome is the main question the study is designed to answer.

Largest Change From Baseline on Clinical Pain Rating
The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.
Measured: 8 hour study session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201727 Nov 2023

First posted4 Apr 2017
Study start1 Nov 2017
Primary completion17 Nov 2023
Study completion27 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by Johns Hopkins 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: This study will include 4 sessions. Participants will be randomly assigned to the order in which they receive one drug (or combination of drugs) per session at each study visit.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03098563
Sponsor's protocol ID: IRB00125605
Other IDs: R01DA042751
Status last verified: Nov 2024
First submitted: 17 Mar 2017
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hamilton KR, Mun CJ, Sadik E, Bergeria CL, Huhn AS, Speed TJ, Vandrey R, Dunn KE, Campbell CM. Evaluating the Acute Effects of the Cannabinoid Dronabinol and the Opioid Hydromorphone Alone and in Combination: A Double-blind, Randomized, Placebo-controlled Trial in Knee Osteoarthritis. Anesthesiology. 2026 May 1;144(5):1187-1198. doi: 10.1097/ALN.0000000000005925. Epub 2025 Dec 31.
PubMed 41481837

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
ClinicalTrials.gov ID: NCT03098563
Acronym / sponsor ID: IRB00125605
Conditions: Knee Osteoarthritis
Keywords: Clinical Trial, Phase II
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Nov 2017 (actual)
Primary completion: 17 Nov 2023 (actual)
Study completion: 27 Nov 2023 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: This study will include 4 sessions. Participants will be randomly assigned to the order in which they receive one drug (or combination of drugs) per session at each study visit.

Arm	Type	Receives
Arm 1	Experimental	Drug: Blinded study medicationBlinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Arm 2	Experimental	Drug: Blinded study medicationBlinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Arm 3	Experimental	Drug: Blinded study medicationBlinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
Arm 4	Experimental	Drug: Blinded study medicationBlinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of knee osteoarthritis
Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
Medically cleared to take study medications
Are not pregnant or breast feeding
Willing to comply with the study protocol.

Key exclusion criteria (5 listed)

Pain other than Knee Osteoarthritis
Taking opioids for pain
Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
Known allergy to the blinded study medications

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
Blinded study medicationAlso: stimulants, benzodiazepines, opioids, cannabinoids, over the counter (OTC) medications, placeboBlinded study medication: This is a double-blind within-subject Phase II trial. Study medications will remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications or placebo (sugar pill). All subjects will serve as their own control. Study medication administration will be randomized within each participant.	Drug	Arm 1, Arm 2, Arm 3, Arm 4

Primary outcome

Largest Change From Baseline on Clinical Pain Rating
Time frame: 8 hour study session
The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydromorphone+Placebo	58	58
Placebo+Placebo	0	0
Dronabinol + Placebo	0	0
Hydromorphone + Dronabinol	0	0

Primary outcome: Largest Change From Baseline on Clinical Pain Rating

Time frame: 8 hour study session. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo + Placebo n = 58	Hydromorphone + Placebo n = 58	Dronabinol + Placebo n = 58	Hydromorphone + Dronabinol n = 58
Baseline	24.19 (23.63)	30.48 (27.39)	28.55 (26.78)	26.38 (25.86)
Peak Effect	12.76 (17.81)	9.40 (16.27)	12.80 (17.50)	12.41 (16.92)

Placebo + Placebo vs Hydromorphone + Placebo vs Dronabinol + Placebo vs Hydromorphone + Dronabinol: p = .021, ANOVA

Adverse events

Time frame: Up to 40 hours. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Placebo	0 of 58 (0%)	15 of 58 (25.9%)	0 of 58
Hydromorphone + Placebo	0 of 58 (0%)	10 of 58 (17.2%)	0 of 58
Dronabinol + Placebo	0 of 58 (0%)	13 of 58 (22.4%)	0 of 58
Hydromorphone + Dronabinol	0 of 58 (0%)	21 of 58 (36.2%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41481837Hamilton KR, Mun CJ, Sadik E, Bergeria CL, Huhn AS, Speed TJ, Vandrey R, Dunn KE, Campbell CM. Evaluating the Acute Effects of the Cannabinoid Dronabinol and the Opioid Hydromorphone Alone and in Combination: A Double-blind, Randomized, Placebo-controlled Trial in Knee Osteoarthritis. Anesthesiology. 2026 May 1;144(5):1187-1198. doi: 10.1097/ALN.0000000000005925. Epub 2025 Dec 31.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.

Claudia M Campbell, Ph.D. principal investigator

Johns Hopkins University

Kelly E Dunn, Ph.D. principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinded study medication in people with Knee Osteoarthritis, run by Johns Hopkins 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2024. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Largest Change From Baseline on Clinical Pain Rating (time frame: 8 hour study session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098563, which also lists 1 linked publication.

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 11 Dec 2024.