Gabapentin and Tizanidine for Insomnia in Chronic Pain

• Status: Enrolling by invitation
• Trial end date: 2023-07-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Treatments: Gabapentin; Tizanidine

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)