Gabapentin + Tizanidine for Insomnia in Chronic Pain

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Disqualifiers: Pregnancy, Breastfeeding, Chronic kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests gabapentin and tizanidine, two pain-relief medications, to determine their effectiveness for people with chronic pain who have trouble sleeping. Participants will receive either gabapentin, tizanidine, or a placebo (a harmless pill with no active medicine) to compare effects on sleep. This trial suits those who have experienced pain for at least three months and struggle with sleep issues. Participants must communicate in English and have email access for completing surveys. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that gabapentin is generally well-tolerated. Since 1993, it has been used and approved by the FDA for treating seizures and nerve pain. Some studies suggest it can improve sleep without causing many serious side effects. However, warnings exist about possible breathing problems, especially when combined with medications like opioids.

Tizanidine, in contrast, relaxes muscles and can induce sleepiness, aiding some people with muscle pain in sleeping better. Although commonly used, tizanidine is not specifically approved by the FDA for sleep disorders.

Both gabapentin and tizanidine have been studied in various contexts and are considered relatively safe when used properly. Always consult a healthcare provider to understand any potential risks based on personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a fresh approach to tackling insomnia associated with chronic pain. Gabapentin and Tizanidine, the drugs being studied, work differently from typical sleep medications like benzodiazepines or non-benzodiazepine sleep aids. Gabapentin, primarily used for nerve pain, might help improve sleep by calming nerve activity, while Tizanidine, a muscle relaxant, can help ease muscle-related discomfort, potentially aiding in better sleep quality. Unlike standard treatments that mainly target sleep directly, these drugs could address the underlying pain issues contributing to insomnia, offering a dual benefit. This approach could lead to more effective relief for individuals struggling with both chronic pain and sleep disturbances.

What evidence suggests that this trial's treatments could be effective for insomnia in chronic pain?

Research shows that gabapentin, one of the treatments in this trial, can improve sleep by increasing both duration and depth. It helps individuals stay asleep longer and reduces the time spent awake after initially falling asleep. For those experiencing ongoing pain, gabapentin can lessen pain, potentially leading to better sleep.

Tizanidine, another treatment option in this trial, has improved sleep quality for individuals with long-term muscle pain. Studies indicate it can reduce pain levels and enhance overall sleep. This trial examines both gabapentin and tizanidine for their potential to alleviate insomnia in people with chronic pain. ^{1 4 6 7 8}

Who Is on the Research Team?

Nathaniel Schuster, MD

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with chronic pain lasting over three months, a BMI of 35 or less, and trouble sleeping as shown by an AIS score of 6 or more. It's not for pregnant or breastfeeding women, those with kidney disease, heart rhythm issues (QT prolongation), allergies to the drugs being tested, shift workers, people who can't do daily surveys or might have jetlag during the study.

Inclusion Criteria

Must have access to email and be able to respond to REDCap questionnaires in English

I have been in pain for 3 months or more.

I have trouble sleeping and my sleep issues score is 6 or higher.

Exclusion Criteria

You are allergic to tizanidine or gabapentin, or cannot tolerate them.

You have fainted before or are scared of blood or needles.

You plan to travel across different time zones while the trial is happening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3-night trials each of placebo, gabapentin, or tizanidine in a randomized, double-blind order

3 weeks

Weekly assessments on Monday

Washout

4-day washout period between treatments to clear previous medication effects

4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gabapentin
• Placebo
• Tizanidine

Trial Overview The trial is testing if gabapentin and tizanidine help with sleep problems in people with long-term pain. Participants will be randomly assigned to receive either one of these drugs or a placebo without knowing which they're getting. The effects on their sleep will then be compared.

How Is the Trial Designed?

Group I: Tizanidine 2mg Experimental Treatment 1 Intervention

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

Group II: Gabapentin 300mg Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

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

Gabapentin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurontin for:

• Postherpetic neuralgia
• Partial-onset seizures

Approved in European Union as Gabapentin for:

• Peripheral neuropathic pain
• Partial-onset seizures

Approved in Canada as Gabapentin for:

• Postherpetic neuralgia
• Partial-onset seizures

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5510619/

Efficacy and Tolerability of Gabapentin in Adults with Sleep ... Clinical studies have revealed that gabapentin could improve the objective and subjective outcomes of sleep disturbance in patient with medical illness (13–37).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04429347

Gabapentin and Tizanidine for Insomnia in Chronic Pain 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 ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.4108

A Randomized, Double-Blind, Single-Dose, Placebo ... Participants with occasional disturbed sleep treated with gabapentin had significantly longer sleep duration and greater depth (versus placebo)

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4173088/

A Randomized, Double-Blind, Placebo-Controlled, ... Gabapentin significantly improved sleep efficiency, decreased wake after sleep onset (WASO), and increased slow wave sleep relative to baseline. Occasional ...

5. thennt.com thennt.com/nnt/gabapentin-chronic-neuropathic-pain/

Gabapentin for Chronic Neuropathic Pain Patients generally consider a 50% reduction in their chronic pain a useful outcome because it has been associated with important beneficial effects on sleep ...

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin

Serious breathing difficulties with gabapentin and pregabalin One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. The other trial showed ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493228/

Gabapentin - StatPearls - NCBI Bookshelf Gabapentin is an anticonvulsive medication that received approval from the US Food and Drug Administration (FDA) in 1993 and has been available in generic form ...

8. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.pn.2023.11.11.29

Before You Prescribe Gabapentin, Consider These Risks Additionally, gabapentinoids are still considered relatively benign medications and safer alternatives to controlled substances such as opioids ...