Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

NCT03098563 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00125605R01DA042751
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Clinical Trial; Phase II

Outcome Measures

Primary Outcomes (1)

• 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.

  8 hour study session

Study Arms (4)

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.

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.

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.

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.

Drug: Blinded study medication

Interventions

Blinded study medication DRUG

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.

Also known as: stimulants, benzodiazepines, opioids, cannabinoids, over the counter (OTC) medications, placebo

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Central Nervous System Stimulants; Benzodiazepines; Analgesics, Opioid; Cannabinoids; Nonprescription Drugs; Dosage Forms

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Terpenes; Hydrocarbons; Organic Chemicals; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Claudia Campbell
• Organization: Johns Hopkins University

ccampb41@jhmi.edu

4105507989

Study Officials

• Claudia M Campbell, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Kelly E Dunn, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Within-subjects design. Two pills will be administered at each study visit. Participants and study staff will be blind to the drug(s) administered.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 4, 2017
• Study Start: November 1, 2017
• Primary Completion: November 17, 2023
• Study Completion: November 27, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)