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Gabapentin and Tizanidine for Insomnia in Chronic Pain

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ClinicalTrials.gov Identifier: NCT04429347
Recruitment Status : Enrolling by invitation
First Posted : June 12, 2020
Last Update Posted : July 30, 2020
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Nathaniel Schuster, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Insomnia Due to Medical Condition Chronic Pain Drug: Gabapentin Drug: Placebo Drug: Tizanidine Phase 2

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 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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, Double-bind, Placebo-controlled, Crossover Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 3 treatments will be identically encapsulated by the study pharmacist. The study pharmacist will place the drug capsules in identical sealed plastic bags labeled "Treatment 1" through "Treatment 3".
Primary Purpose: Treatment
Official Title: Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial.
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : July 29, 2022
Estimated Study Completion Date : July 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Tizanidine 2mg
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Drug: 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 Name: Zanaflex

Experimental: Gabapentin 300mg
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Drug: 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)
Other Name: Neurontin

Placebo Comparator: Placebo
Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules
Drug: Placebo
Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules
Other Names:
  • Sham
  • Sugar Pill




Primary Outcome Measures :
  1. Sleep quality [ Time Frame: Monday after 3 nights of drug intake ]

    Comparison of group means for Athens Insomnia Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine.

    Total Athens Insomnia Scale score ranges from 0 to 24. The higher the score, the more severe the insomnia symptoms experienced by the patient.



Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: Monday after 3 nights of drug intake ]

    Comparison of group means for Visual Analog Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine.

    Visual Analog Scale score ranges from 0 to 10. The higher the score, the worse the pain experienced by the patient.


  2. Alertness [ Time Frame: Monday after 3 nights of drug intake ]

    Comparison of group means for Stanford Sleepiness Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine.

    Stanford Sleepiness Scale score ranges from 1 to 7. The higher the score, the more sleepy and less alert the patient.


  3. Overall improvement [ Time Frame: Monday after 3 nights of drug intake ]

    Comparison of group means for Patient Global Impression of Change scores between the 3 treatment groups placebo, gabapentin and tizanidine.

    Patient Global Impression of Change score ranges from 1 to 7. The higher the score, the more improvement reported by the patient.


  4. Categorical assessment of insomnia improvement [ Time Frame: Monday after 3 nights of drug intake ]

    Percentage of patients with a 30% improvement from baseline in individual Athens Insomnia Scale scores for each of the 3 treatments placebo, gabapentin and tizanidine.

    Total Athens Insomnia Scale score ranges from 0 to 24. The higher the scores, the more severe the insomnia symptoms experienced by the patient.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429347


Locations
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United States, California
Center for Pain Medicine, UC San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Nathaniel Schuster, MD UC San Diego
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Responsible Party: Nathaniel Schuster, Assistant Profesor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04429347    
Other Study ID Numbers: 191167
UL1TR000100 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 12 months and ending 3 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nathaniel Schuster, University of California, San Diego:
Insomnia
Chronic Pain
Gabapentin
Tizanidine
Placebo
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gabapentin
Tizanidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists