Status:
COMPLETED
Gabapentin and Tizanidine for Insomnia in Chronic Pain
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Insomnia Due to Medical Condition
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo-controlled, randomized, crossover trial aimed at assessing the effect of gabapentin and tizanidine, two pain medications, on insomnia in chronic pain patients.
Detailed Description
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 chro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04429347
Start Date
July 29 2020
End Date
December 1 2024
Last Update
January 3 2025
Active Locations (1)
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1
Center for Pain Medicine, UC San Diego
La Jolla, California, United States, 92037