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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277038
• Other study ID #: SalemAnaesth 2021 ClonZop
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: March 2022
• Source: Salem Anaesthesia Pain Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia Chronic
• Pain, Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Clonidine 0.1mg pill
Routine prescription for insomnia
• Clonidine 0.2mg pill
Routine prescription for insomnia
• Zopiclone 3.75mg pill
Routine prescription for insomnia
• Zopiclone 7.5mg pill
Routine prescription for insomnia

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lader M. Zopiclone: is there any dependence and abuse potential? J Neurol. 1997 Apr;244(4 Suppl 1):S18-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score, objective measurement using the validated Numeric Pain Rating scale	Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain	3 weeks