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Search / Trial NCT04429347

Gabapentin and Tizanidine for Insomnia in Chronic Pain

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jun 10, 2020

Trial Information

Current as of April 24, 2025

Completed

Keywords

Insomnia Chronic Pain Gabapentin Tizanidine Placebo

ClinConnect Summary

Chronic pain and insomnia are highly prevalent conditions affecting 10-25% and 6-10% of the general population, respectively. Importantly, these two conditions frequently co-occur, with 50-80% of chronic pain patients reporting sleep disturbances. Identifying medication that alleviates pain and insomnia simultaneously may help reduce risks associated with polypharmacy, including drug-drug interactions.

In this double-blind, placebo-controlled, randomized, crossover trial, gabapentin and tizanidine, two drugs which are respectively commonly used to treat neuropathic and musculoskeletal pain...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • BMI ≤ 35
  • Any ethnicity
  • Must be able to communicate in English
  • Must have access to email and be able to respond to REDCap questionnaires in English
  • Has a chronic pain condition (≥ 3 months of pain)
  • Reports sleep disturbance and scores ≥ 6 on AIS questionnaire
  • Ability to provide informed consent
  • Exclusion Criteria:
  • Pregnancy
  • Breastfeeding
  • Has diagnosis of chronic kidney disease
  • Has known QT prolongation \>500 msec on prior EKG
  • Inability to complete daily questionnaires
  • Allergy to, or intolerance of, any of tizanidine or gabapentin
  • Shift workers
  • Anticipated travel across multiple time zones (jetlag) during the duration of the trial
  • Circadian misalignment
  • Prior syncope experience and/or fear of blood/needles (if a blood draw is required)

Trial Officials

Nathaniel Schuster, MD

Principal Investigator

UC San Diego

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

La Jolla, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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