Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098563
• Other study ID #: IRB00125605
• Secondary ID: R01DA042751
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: November 27, 2023

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 27, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Blinded study medication
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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Largest change from baseline on pain rating	The study will measure whether blinded study medications change pain ratings and pain sensitivity on laboratory pain tests.	8 hour study session