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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nathaniel Schuster, MD

Principal Investigator

UC San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+