Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Drug: Blinded study medication

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03098563

R01DA042751 (U.S. NIH Grant/Contract)

IRB00125605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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58 participants in 4 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Blinded study medication

Arm 2

Experimental group

Description:

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.

Treatment:

Drug: Blinded study medication

Arm 3

Experimental group

Description:

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.

Treatment:

Drug: Blinded study medication

Arm 4

Experimental group

Description:

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.

Treatment:

Drug: Blinded study medication