Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
CompletedNCT05277038
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Brief summary (from the registry)
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.
Study details
- Official title
- Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
- Conditions
- Insomnia Chronic
- Pain, Chronic
- Interventions
- Drug: Clonidine 0.1mg pill
- Drug: Clonidine 0.2mg pill
- Drug: Zopiclone 3.75mg pill
- Drug: Zopiclone 7.5mg pill
- Sponsor
- Salem Anaesthesia Pain Clinic
- Start date
- 2022-03-01
- Primary completion
- 2022-11-05
- Sex
- All
- Age range
- from 20 Years to 99 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Salem Anaesthesia Pain Clinic | Surrey | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05277038