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Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03098563
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Blinded study medication Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: Within-subjects design. Two pills will be administered at each study visit. Participants and study staff will be blind to the drug(s) administered.
Primary Purpose: Basic Science
Official Title: Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Arm 1
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
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.
Other Name: stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo

Experimental: Arm 2
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
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.
Other Name: stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo

Experimental: Arm 3
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
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.
Other Name: stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo

Experimental: Arm 4
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
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.
Other Name: stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo




Primary Outcome Measures :
  1. Largest change from baseline on pain rating [ Time Frame: 8 hour study session ]
    The study will measure whether blinded study medications change pain ratings and pain sensitivity on laboratory pain tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098563


Contacts
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Contact: Claudia M Campbell, Ph.D. 410-550-7989 ccampb41@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jim Stone    410-550-7906    jstone8@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Claudia M Campbell, Ph.D. Johns Hopkins University
Principal Investigator: Kelly E Dunn, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03098563     History of Changes
Other Study ID Numbers: IRB00125605
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
Clinical Trial
Phase II
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs