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Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

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ClinicalTrials.gov Identifier: NCT05277038
Recruitment Status : Completed
First Posted : March 14, 2022
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
Salem Anaesthesia Pain Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Insomnia Chronic Pain, Chronic Drug: Clonidine 0.1mg pill Drug: Clonidine 0.2mg pill Drug: Zopiclone 3.75mg pill Drug: Zopiclone 7.5mg pill

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 150 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
Actual Study Start Date : March 1, 2022
Actual Primary Completion Date : November 5, 2022
Actual Study Completion Date : November 5, 2022


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.
Drug: Clonidine 0.1mg pill
Routine prescription for insomnia
Other Name: Clonidine 0.1mg tablet

Drug: Clonidine 0.2mg pill
Routine prescription for insomnia
Other Name: Clonidine 0.2mg tablet

Drug: Zopiclone 3.75mg pill
Routine prescription for insomnia
Other Name: Zopiclone 3.75mg tablet

Drug: Zopiclone 7.5mg pill
Routine prescription for insomnia
Other Name: Zopiclone 7.5mg tablet




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A cohort of consecutive adult patients who underwent pain management at a Canadian pain clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05277038


Locations
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Canada, British Columbia
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, Canada, V3S 7J1
Sponsors and Collaborators
Salem Anaesthesia Pain Clinic
Investigators
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Principal Investigator: Olu Bamgbade, MD, FRCPC Salem Anaesthesia Pain Clinic
Publications:
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Responsible Party: Salem Anaesthesia Pain Clinic
ClinicalTrials.gov Identifier: NCT05277038    
Other Study ID Numbers: SalemAnaesth 2021 ClonZop
First Posted: March 14, 2022    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salem Anaesthesia Pain Clinic:
sedative
hypnotic
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Clonidine
Zopiclone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants