CompletedPhase 2
Gabapentin and Tizanidine for Insomnia in Chronic Pain
Key facts
- Who runs it
- University of California, San Diego
- Where
- La Jolla, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 9 people enrolled
- Started
- 29 Jul 2020
- Ended
- 1 Dec 2024
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Gabapentin
- Placebo
- Tizanidine
- Record updated
- 3 January 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior syncope experience and/or fear of blood/needles (if a blood draw is required)
- Has diagnosis of chronic kidney disease
- Allergy to, or intolerance of, any of tizanidine or gabapentin
- Has known QT prolongation >500 msec on prior EKG
- Pregnancy
- Breastfeeding
- Inability to complete daily questionnaires
- Shift workers
- Anticipated travel across multiple time zones (jetlag) during the duration of the trial
- Circadian misalignment
Where in United States
- Center for Pain Medicine, UC San DiegoLa Jolla, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Tizanidine 2mgTreatment being tested
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Treatment: Tizanidine
- Gabapentin 300mgTreatment being tested
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Treatment: Gabapentin
- PlaceboPlacebo, for comparison
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial.
- Record updated
- 3 January 2025