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

• ClinicalTrials.gov Identifier: NCT03548454
• Recruitment Status: Recruiting
• First Posted: June 7, 2018
• Last Update Posted: May 5, 2022
• Sponsor: Stanford University
• Information provided by (Responsible Party): Vafi Salmasi, Stanford University

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
Chronic Pain	Drug: Duloxetine; Drug: Desipramine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: September 20, 2018
• Estimated Primary Completion Date: July 31, 2025
• Estimated Study Completion Date: July 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 Name: 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 Name: Norpramin

Outcome Measures

Primary Outcome Measures :

1. Pain Intensity [ Time Frame: 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 [ Time Frame: Monthly for 6 months ]
   National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function
2. Pain Interference [ Time Frame: Monthly for 6 months ]
   National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference
3. Depression [ Time Frame: Monthly for 6 months ]
   National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression
4. Anxiety [ Time Frame: Monthly for 6 months ]
   National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety
5. Adherence [ Time Frame: Monthly for 6 months ]
   Time to stopping either medication in days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Vafi Salmasi, MD.; 650-725-0246; vsalmasi@stanford.edu

Locations

United States, California

Stanford Pain Management Center; Recruiting

Redwood City, California, United States, 94063

Contact: Vafi Salmasi, MD. 650-725-0246 vsalmasi@stanford.edu

Sponsors and Collaborators

Stanford University

Investigators

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

More Information

• Responsible Party: Vafi Salmasi, Clinical Instructor, Stanford University
• ClinicalTrials.gov Identifier: NCT03548454
• Other Study ID Numbers: 44758
• First Posted: June 7, 2018
• Last Update Posted: May 5, 2022
• Last Verified: May 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; Pain; Neurologic Manifestations; Duloxetine Hydrochloride; Desipramine; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antidepressive Agents; Psychotropic Drugs; Dopamine Agents; Antidepressive Agents, Tricyclic; Enzyme Inhibitors; Adrenergic Uptake Inhibitors; Adrenergic Agents