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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Desipramine
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Pain Management CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Duloxetine

Desipramine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical Function
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function
Pain Interference
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference
Depression
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression
Anxiety
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety
Adherence
Time to stopping either medication in days

Full Information

First Posted
April 17, 2018
Last Updated
May 3, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03548454
Brief Title
Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Official Title
Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
Arm Title
Desipramine
Arm Type
Experimental
Arm Description
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Open label prescription
Intervention Type
Drug
Intervention Name(s)
Desipramine
Other Intervention Name(s)
Norpramin
Intervention Description
Open label prescription
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Average and worst pain intensity reported by participants on a numerical rating scale of 0-10
Time Frame
Monthly for 6 months
Secondary Outcome Measure Information:
Title
Physical Function
Description
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function
Time Frame
Monthly for 6 months
Title
Pain Interference
Description
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference
Time Frame
Monthly for 6 months
Title
Depression
Description
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression
Time Frame
Monthly for 6 months
Title
Anxiety
Description
National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety
Time Frame
Monthly for 6 months
Title
Adherence
Description
Time to stopping either medication in days
Time Frame
Monthly for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age of 18 years old or above Persistent pain for more than 3 months Candidate for treatment by anti-depressant based on treating pain provider Exclusion criteria: 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) Contraindication to taking duloxetine or desipramine Patient refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vafi Salmasi, MD.
Phone
650-725-0246
Email
vsalmasi@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vafi Salmasi, MD.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Pain Management Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vafi Salmasi, MD.
Phone
650-725-0246
Email
vsalmasi@stanford.edu

12. IPD Sharing Statement

Learn more about this trial

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

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