Gabapentin and Tizanidine for Insomnia in Chronic Pain

University of California San Diego

Status and phase: Completed; Phase 2

Conditions: Insomnia Due to Medical Condition; Chronic Pain

Treatments: Drug: Gabapentin; Drug: Placebo; Drug: Tizanidine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04429347

191167

UL1TR000100 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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9 participants in 3 patient groups, including a placebo group

Tizanidine 2mg

Experimental group

Description:

Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules

Treatment:

Drug: Tizanidine

Gabapentin 300mg

Experimental group

Description:

Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules

Treatment:

Drug: Placebo