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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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