Insomnia Due to Medical ConditionPhase 2NCT04429347
Gabapentin and Tizanidine for Insomnia in Chronic Pain
A Phase 2 study testing Gabapentin and Tizanidine in people with Insomnia Due to Medical Condition and Chronic Pain, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia Due to Medical Condition, Chronic Pain
- What is being tested?
- Gabapentin and Tizanidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Pain Medicine, UC San Diego
La Jolla, California, 92037
About this study
Official title: Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover 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.
Read the detailed description
Chronic pain and insomnia are highly prevalent conditions affecting 10-25% and 6-10% of the general population, respectively. Importantly, these two conditions frequently co-occur, with 50-80% of chronic pain patients reporting sleep disturbances. Identifying medication that alleviates pain and insomnia simultaneously may help reduce risks associated with polypharmacy, including drug-drug interactions.
In this double-blind, placebo-controlled, randomized, crossover trial, gabapentin and tizanidine, two drugs which are respectively commonly used to treat neuropathic and musculoskeletal pain, will be compared to each other and to placebo in their ability to alleviate insomnia in chronic pain patients.
In each week, patients will receive 3-night (Friday-Sunday) trials each of placebo, gabapentin or tizanidine in a randomized, double-blind order and will monitor their insomnia using the Athens Insomnia Scale (AIS) questionnaire (adapted to fit the time frame of this trial). The primary outcome consists of the difference in mean AIS scores between the 3 treatments at the primary time point, which is Monday of each week (after 3 nights of drug intake).
Patients will also monitor their sleepiness, pain relief and overall improvement as secondary variants using the Stanford Sleepiness Scale (SSS), Visual Analog Scale (VAS), and Patient's Global Impression of Change (PGIC) questionnaires respectively.
Scores on the Monday preceding the first treatment will serve as baseline and the period between treatments (i.e. Monday-Thursday nights) will serve as a 4-day washout period between treatments.
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 different from one another.
- Conditions
- Insomnia Due to Medical Condition, Chronic Pain
- Being tested
- Gabapentin, Placebo, Tizanidine
- Keywords
- Insomnia, Chronic Pain, Gabapentin, Tizanidine, Placebo
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
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)
PlaceboDrug
Also called Sham, Sugar Pill
Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules
TizanidineDrug
Also called Zanaflex
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)
| Study group | Role | What they receive |
|---|---|---|
| Tizanidine 2mg | Experimental | Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules Receives: Drug: Tizanidine |
| Gabapentin 300mg | Experimental | Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Friday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monday after 3 nights of drug intake
Secondary outcomes (4)
Pain Intensity
Comparison of group means for Visual Analog Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine.
Visual Analog Scale score ranges from 0 to 10. The higher the score, the worse the pain experienced by the patient.
Measured: Monday after 3 nights of drug intake
Alertness
Comparison of group means for Stanford Sleepiness Scale scores between the 3 treatment groups placebo, gabapentin and tizanidine.
Stanford Sleepiness Scale score ranges from 1 to 7. The higher the score, the more sleepy and less alert the patient.
Measured: Monday after 3 nights of drug intake
Overall improvement
Comparison of group means for Patient Global Impression of Change scores between the 3 treatment groups placebo, gabapentin and tizanidine.
Patient Global Impression of Change score ranges from 1 to 7. The higher the score, the more improvement reported by the patient.
Measured: Monday after 3 nights of drug intake
Categorical assessment of insomnia improvement
Percentage of patients with a 30% improvement from baseline in individual Athens Insomnia Scale scores for each of the 3 treatments placebo, gabapentin and tizanidine.
Total Athens Insomnia Scale score ranges from 0 to 24. The higher the scores, the more severe the insomnia symptoms experienced by the patient.
Measured: Monday after 3 nights of drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start29 Jul 2020
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Medical ConditionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-bind, Placebo-controlled, Crossover Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Nathaniel Schuster, University of California, San Diego
- Investigators
- Nathaniel Schuster, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429347
- Sponsor's protocol ID
- 191167
- Other IDs
- UL1TR000100
- Status last verified
- Jan 2025
- First submitted
- 22 May 2020
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial.
- ClinicalTrials.gov ID
- NCT04429347
- Acronym / sponsor ID
- 191167
- Conditions
- Insomnia Due to Medical Condition, Chronic Pain
- Keywords
- Insomnia, Chronic Pain, Gabapentin, Tizanidine, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain and insomnia are highly prevalent conditions affecting 10-25% and 6-10% of the general population, respectively. Importantly, these two conditions frequently co-occur, with 50-80% of chronic pain patients reporting sleep disturbances. Identifying medication that alleviates pain and insomnia simultaneously may help reduce risks associated with polypharmacy, including drug-drug interactions.
In this double-blind, placebo-controlled, randomized, crossover trial, gabapentin and tizanidine, two drugs which are respectively commonly used to treat neuropathic and musculoskeletal pain, will be compared to each other and to placebo in their ability to alleviate insomnia in chronic pain patients.
In each week, patients will receive 3-night (Friday-Sunday) trials each of placebo, gabapentin or tizanidine in a randomized, double-blind order and will monitor their insomnia using the Athens Insomnia Scale (AIS) questionnaire (adapted to fit the time frame of this trial). The primary outcome consists of the difference in mean AIS scores between the 3 treatments at the primary time point, which is Monday of each week (after 3 nights of drug intake).
Patients will also monitor their sleepiness, pain relief and overall improvement as secondary variants using the Stanford Sleepiness Scale (SSS), Visual Analog Scale (VAS), and Patient's Global Impression of Change (PGIC) questionnaires respectively.
Scores on the Monday preceding the first treatment will serve as baseline and the period between treatments (i.e. Monday-Thursday nights) will serve as a 4-day washout period between treatments.
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 different from one another.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-bind, Placebo-controlled, Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| Tizanidine 2mg | Experimental | Drug: TizanidineFriday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules |
| Gabapentin 300mg | Experimental | Drug: GabapentinFriday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules |
| Placebo | Placebo comparator | Drug: PlaceboFriday night: 1 capsule Saturday night: 2 capsules Sunday night: Subject chooses 1-2 capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- Pregnancy
- Breastfeeding
- Has diagnosis of chronic kidney disease
- Has known QT prolongation >500 msec on prior EKG
- Inability to complete daily questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: NeurontinFriday 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) | Drug | Gabapentin 300mg |
| PlaceboAlso: Sham, Sugar PillFriday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules | Drug | Placebo |
| TizanidineAlso: ZanaflexFriday 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) | Drug | Tizanidine 2mg |
Primary outcome
Sleep quality
Time frame: Monday after 3 nights of drug intake
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.
4 secondary outcomes
Pain Intensity
Time frame: Monday after 3 nights of drug intake
Alertness
Time frame: Monday after 3 nights of drug intake
Overall improvement
Time frame: Monday after 3 nights of drug intake
Categorical assessment of insomnia improvement
Time frame: Monday after 3 nights of drug intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared in a manner TBD based on funding availability and journal requirements.
Related trials for Insomnia Due to Medical Condition
Recruiting
Sleep Well Despite Persistent Pain Symptoms
Insomnia Chronic, Insomnia Due to Medical Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Schuster, MD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin and Tizanidine in people with Insomnia Due to Medical Condition and Chronic Pain, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Monday after 3 nights of drug intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.