Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2020-07-29
2024-12-01
Brief Summary
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Detailed Description
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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, will be compared to each other and to placebo in their ability to alleviate insomnia in chronic pain patients.
In each week, patients will receive 3-night (Friday-Sunday) trials each of placebo, gabapentin or tizanidine in a randomized, double-blind order and will monitor their insomnia using the Athens Insomnia Scale (AIS) questionnaire (adapted to fit the time frame of this trial). The primary outcome consists of the difference in mean AIS scores between the 3 treatments at the primary time point, which is Monday of each week (after 3 nights of drug intake).
Patients will also monitor their sleepiness, pain relief and overall improvement as secondary variants using the Stanford Sleepiness Scale (SSS), Visual Analog Scale (VAS), and Patient's Global Impression of Change (PGIC) questionnaires respectively.
Scores on the Monday preceding the first treatment will serve as baseline and the period between treatments (i.e. Monday-Thursday nights) will serve as a 4-day washout period between treatments.
Our hypothesis is that gabapentin and tizanidine will both be more effective than placebo in alleviating insomnia in chronic pain patients but will not be different from one another.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Tizanidine 2mg
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Tizanidine
Friday night: 1 capsule of 2 mg, Saturday night: 2 capsule of 2 mg (total 4 mg), Sunday night: choice of 1 or 2 capsules of 2 mg (total of 2 or 4 mg)
Gabapentin 300mg
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Gabapentin
Friday night: 1 capsule of 300 mg, Saturday night: 2 capsule of 300 mg (total 600 mg), Sunday night: choice of 1 or 2 capsule of 300 mg (total of 300 or 600 mg)
Placebo
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Placebo
Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules
Interventions
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Gabapentin
Friday night: 1 capsule of 300 mg, Saturday night: 2 capsule of 300 mg (total 600 mg), Sunday night: choice of 1 or 2 capsule of 300 mg (total of 300 or 600 mg)
Placebo
Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules
Tizanidine
Friday night: 1 capsule of 2 mg, Saturday night: 2 capsule of 2 mg (total 4 mg), Sunday night: choice of 1 or 2 capsules of 2 mg (total of 2 or 4 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
University of California, San Diego
OTHER
Responsible Party
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Nathaniel Schuster
Assistant Profesor
Principal Investigators
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Nathaniel Schuster, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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Center for Pain Medicine, UC San Diego
La Jolla, California, United States
Countries
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Other Identifiers
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191167
Identifier Type: -
Identifier Source: org_study_id
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