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

Stanford University

Status and phase: Completed; Phase 4

Conditions: Chronic Pain

Treatments: Drug: Desipramine; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03548454

44758

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Duloxetine

Experimental group

Description:

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

Treatment:

Drug: Duloxetine

Desipramine

Experimental group

Description:

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

Treatment:

Drug: Desipramine