- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277038
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives: Chronic pain is associated with insomnia. The objective of this clinical study is to compare the efficacy and safety of different prescribed doses of Zopiclone and Clonidine; for the management of insomnia in patients with chronic pain.
Methods: A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant. Data were analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 was considered significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3S 7J1
- Salem Anaesthesia Pain Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult chronic pain patients
- good treatment compliance
- severe chronic insomnia
- failure of non-pharmacologic sleep therapy
- regular zopiclone therapy for 3 months or more
- regular sleep diary
- regular pain diary
- informed consent for diary review
- consent for clinical record quality assurance review.
Exclusion Criteria:
- obstructive sleep apnoea
- body mass index (BMI) ≥40
- organ insufficiency
- cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
- unreliable diary
- cannabis use
- regular alcohol intake
- stimulant use
- substance abuse
- poor treatment compliance
- high dose opioid
- gabapentinoid use
- sedative use
- mild insomina
- irregular zopiclone intake
- regular zopiclone therapy for less than 3 months
- previous adverse/allergic reactions to clonidine or zopiclone.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clonidine vs Zopiclone for insomnia
Consecutive adult patients who underwent pain management at a Canadian pain clinic.
The patients were subsequently prescribed and provided zopiclone 3.75mg tablet (1-2 tablets per dose), and clonidine 0.1mg tablet (1-2 tablets per dose).
They were advised to take either clonidine or zopiclone on alternate nights.
For each medication, they alternated the doses of 1 tablet or 2 tablets at subsequent nightly administrations.
The four possible medication doses were zopiclone 3.75mg, zopiclone 7.5mg, clonidine 0.1mg, and clonidine 0.2mg; as shown on the sleep diary in Figure 1.
The recommended orders of treatment were zopiclone 7.5mg, clonidine 0.1mg, zopiclone 3.75mg, clonidine 0.2mg; or clonidine 0.2mg, zopiclone 3.75mg, clonidine 0.1mg, zopiclone 7.5mg.
Each patient participated in the study treatment and completed the sleep diary for 3 continuous weeks.
Therefore, each of the four medication doses was used five times by each patient.
|
Routine prescription for insomnia
Other Names:
Routine prescription for insomnia
Other Names:
Routine prescription for insomnia
Other Names:
Routine prescription for insomnia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality score, objective measurement using the validated Likert sleep scale
Time Frame: 3 weeks
|
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score, objective measurement using the validated Numeric Pain Rating scale
Time Frame: 3 weeks
|
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olu Bamgbade, MD, FRCPC, Salem Anaesthesia Pain Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Pain
- Neurologic Manifestations
- Chronic Pain
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Sympatholytics
- Clonidine
- Zopiclone
Other Study ID Numbers
- SalemAnaesth 2021 ClonZop
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Chronic
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Washington University School of MedicineCompletedHip Pain Chronic | Back Pain | Chronic Pain | Knee Pain ChronicUnited States
Clinical Trials on Clonidine 0.1mg pill
-
Aurora Health CareRecruitingPTSD | Sleep | Posttraumatic Stress DisorderUnited States
-
Weill Medical College of Cornell UniversityWithdrawnHealthy VolunteersUnited States
-
Weill Medical College of Cornell UniversityTerminatedCancer | Neuro-Degenerative DiseaseUnited States
-
BioDelivery Sciences InternationalCompletedNeuropathy | Painful Diabetic Neuropathy | Diabetic NeuropathyUnited States
-
Suzhou Alphamab Co., Ltd.Novotech (Australia) Pty LimitedRecruiting
-
Thymon, LLCCompletedHIV InfectionsUnited States
-
University of IowaTerminatedHypertension | AnxietyUnited States
-
Cellid Co., Ltd.Not yet recruitingCOVID-19 | VaccinesKorea, Republic of
-
Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.Completed
-
OnxeoSimbec ResearchCompletedHealthyUnited Kingdom