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

NCT05277038 | Completed DMC

• 1 other identifier: SalemAnaesth 2021 ClonZop
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Pain, Chronic

Keywords

sedative; hypnotic

Outcome Measures

Primary Outcomes (1)

• Sleep quality score, objective measurement using the validated Likert sleep scale

  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 Outcomes (1)

• Pain score, objective measurement using the validated Numeric Pain Rating scale

  3 weeks

Study Arms (1)

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; Drug: Clonidine 0.2mg pill; Drug: Zopiclone 3.75mg pill; Drug: Zopiclone 7.5mg pill

Interventions

Clonidine 0.1mg pill DRUG

Routine prescription for insomnia

Also known as: Clonidine 0.1mg tablet

Clonidine vs Zopiclone for insomnia

Clonidine 0.2mg pill DRUG

Routine prescription for insomnia

Also known as: Clonidine 0.2mg tablet

Clonidine vs Zopiclone for insomnia

Zopiclone 3.75mg pill DRUG

Routine prescription for insomnia

Also known as: Zopiclone 3.75mg tablet

Clonidine vs Zopiclone for insomnia

Zopiclone 7.5mg pill DRUG

Routine prescription for insomnia

Also known as: Zopiclone 7.5mg tablet

Clonidine vs Zopiclone for insomnia

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of consecutive adult patients who underwent pain management at a Canadian pain clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Salem Anaesthesia Pain Clinic: lead

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location

Related Publications (1)

• Lader M. Zopiclone: is there any dependence and abuse potential? J Neurol. 1997 Apr;244(4 Suppl 1):S18-22. doi: 10.1007/BF03160567.

  PMID: 9112585 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Pain

Interventions

Clonidine; Tablets; zopiclone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Olu Bamgbade, MD, FRCPC

  Salem Anaesthesia Pain Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 14, 2022
• Study Start: March 1, 2022
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)