Gabapentin and Tizanidine for Insomnia in Chronic Pain
CompletedPhase 2NCT04429347
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial.
- Conditions
- Insomnia Due to Medical Condition
- Chronic Pain
- Interventions
- Drug: Gabapentin
- Drug: Placebo
- Drug: Tizanidine
- Sponsor
- University of California, San Diego
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Start date
- 2020-07-29
- Primary completion
- 2024-12-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04429347