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Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03548454
Collaborator
(none)
320
Enrollment
1
Location
2
Arms
82.3
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Actual Study Start Date :
Sep 20, 2018
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Duloxetine

Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.

Drug: Duloxetine
Open label prescription
Other Names:
  • Cymbalta

    		•
    Experimental: Desipramine

    Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.

    Drug: Desipramine
    Open label prescription
    Other Names:
  • Norpramin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Intensity [Monthly for 6 months]

      Average and worst pain intensity reported by participants on a numerical rating scale of 0-10

    Secondary Outcome Measures

    1. Physical Function [Monthly for 6 months]

      National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function

    2. Pain Interference [Monthly for 6 months]

      National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference

    3. Depression [Monthly for 6 months]

      National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression

    4. Anxiety [Monthly for 6 months]

      National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety

    5. Adherence [Monthly for 6 months]

      Time to stopping either medication in days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    1. Age of 18 years old or above

    2. Persistent pain for more than 3 months

    3. Candidate for treatment by anti-depressant based on treating pain provider

    Exclusion criteria:

    1. Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)

    2. Contraindication to taking duloxetine or desipramine

    3. Patient refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Pain Management Center Redwood City California United States 94063

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Vafi Salmasi, MD., Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vafi Salmasi, Clinical Instructor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03548454
    Other Study ID Numbers:
    • 44758
    First Posted:
    Jun 7, 2018
    Last Update Posted:
    May 5, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chronic Pain
    Duloxetine Hydrochloride
    Desipramine

    Study Results

    No Results Posted as of May 5, 2022