Gabapentin and Tizanidine for Insomnia in Chronic Pain

NCT04429347 | Completed Phase 2 FDA Drug

• 2 other identifiers: 191167UL1TR000100
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Due to Medical Condition; Chronic Pain

Keywords

Insomnia; Chronic Pain; Gabapentin; Tizanidine; Placebo

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Comparison of group means for Athens Insomnia Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine. Total Athens Insomnia Scale score ranges from 0 to 24. The higher the score, the more severe the insomnia symptoms experienced by the patient.

  Monday after 3 nights of drug intake

Secondary Outcomes (4)

• Pain Intensity

  Monday after 3 nights of drug intake

• Alertness

  Monday after 3 nights of drug intake

• Overall improvement

  Monday after 3 nights of drug intake

• Categorical assessment of insomnia improvement

  Monday after 3 nights of drug intake

Study Arms (3)

Tizanidine 2mg

EXPERIMENTAL

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

Drug: Tizanidine

Gabapentin 300mg

EXPERIMENTAL

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

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gabapentin DRUG

Friday night: 1 capsule of 300 mg, Saturday night: 2 capsule of 300 mg (total 600 mg), Sunday night: choice of 1 or 2 capsule of 300 mg (total of 300 or 600 mg)

Also known as: Neurontin

Gabapentin 300mg

Placebo DRUG

Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules

Also known as: Sham, Sugar Pill

Placebo

Tizanidine DRUG

Friday night: 1 capsule of 2 mg, Saturday night: 2 capsule of 2 mg (total 4 mg), Sunday night: choice of 1 or 2 capsules of 2 mg (total of 2 or 4 mg)

Also known as: Zanaflex

Tizanidine 2mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Center for Pain Medicine, UC San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Interventions

Gabapentin; salicylhydroxamic acid; Sugars; tizanidine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Officials

• Nathaniel Schuster, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. The 3 treatments will be identically encapsulated by the study pharmacist. The study pharmacist will place the drug capsules in identical sealed plastic bags labeled "Treatment 1" through "Treatment 3".
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor

Model Details: Randomized, Double-bind, Placebo-controlled, Crossover Trial

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 12, 2020
• Study Start: July 29, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months and ending 3 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to nmschuster@health.ucsd.edu.

Locations

US (1)