Insomnia ChronicNCT05277038
Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
An observational study of Insomnia Chronic and Pain, Chronic, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Chronic, Pain, Chronic
- What is being tested?
- Clonidine 0.1mg pill, Clonidine 0.2mg pill and Zopiclone 3.75mg pill
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 5 Nov 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of consecutive adult patients who underwent pain management at a Canadian pain clinic
Who may be able to join
- 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
Show all 9Show fewer
- regular pain diary
- informed consent for diary review
- consent for clinical record quality assurance review.
Who cannot join
- obstructive sleep apnoea
- body mass index (BMI) ≥40
- organ insufficiency
- cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Insomnia Chronic, Pain, Chronic
- Being tested
- Clonidine 0.1mg pill, Clonidine 0.2mg pill, Zopiclone 3.75mg pill, Zopiclone 7.5mg pill
- Keywords
- sedative, hypnotic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine 0.1mg pillDrug
Also called Clonidine 0.1mg tablet
Routine prescription for insomnia
Clonidine 0.2mg pillDrug
Also called Clonidine 0.2mg tablet
Routine prescription for insomnia
Zopiclone 3.75mg pillDrug
Also called Zopiclone 3.75mg tablet
Routine prescription for insomnia
Zopiclone 7.5mg pillDrug
Also called Zopiclone 7.5mg tablet
Routine prescription for insomnia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Clonidine 0.1mg pill; Drug: Clonidine 0.2mg pill; Drug: Zopiclone 3.75mg pill; Drug: Zopiclone 7.5mg pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (1)
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Mar 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olu Bamgbade, MD, FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277038
- Sponsor's protocol ID
- SalemAnaesth 2021 ClonZop
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lader M. Zopiclone: is there any dependence and abuse potential? J Neurol. 1997 Apr;244(4 Suppl 1):S18-22. doi: 10.1007/BF03160567.
PubMed 9112585
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05277038
- Acronym / sponsor ID
- SalemAnaesth 2021 ClonZop
- Conditions
- Insomnia Chronic, Pain, Chronic
- Keywords
- sedative, hypnotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonidine vs Zopiclone for insomnia | – | Drug: Clonidine 0.1mg pill, Drug: Clonidine 0.2mg pill, Drug: Zopiclone 3.75mg pill, Drug: Zopiclone 7.5mg pillConsecutive 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of consecutive adult patients who underwent pain management at a Canadian pain clinic
Key inclusion criteria (9 listed)
- adult chronic pain patients
- good treatment compliance
- severe chronic insomnia
- failure of non-pharmacologic sleep therapy
- regular zopiclone therapy for 3 months or more
Key exclusion criteria (19 listed)
- obstructive sleep apnoea
- body mass index (BMI) ≥40
- organ insufficiency
- cognitive disorder
- inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine 0.1mg pillAlso: Clonidine 0.1mg tabletRoutine prescription for insomnia | Drug | Clonidine vs Zopiclone for insomnia |
| Clonidine 0.2mg pillAlso: Clonidine 0.2mg tabletRoutine prescription for insomnia | Drug | Clonidine vs Zopiclone for insomnia |
| Zopiclone 3.75mg pillAlso: Zopiclone 3.75mg tabletRoutine prescription for insomnia | Drug | Clonidine vs Zopiclone for insomnia |
| Zopiclone 7.5mg pillAlso: Zopiclone 7.5mg tabletRoutine prescription for insomnia | Drug | Clonidine vs Zopiclone for insomnia |
Primary outcome
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
1 secondary outcome
Pain score, objective measurement using the validated Numeric Pain Rating scale
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Background: PubMed 9112585Lader M. Zopiclone: is there any dependence and abuse potential? J Neurol. 1997 Apr;244(4 Suppl 1):S18-22. doi: 10.1007/BF03160567.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olu Bamgbade, MD, FRCPC principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia Chronic and Pain, Chronic, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality score, objective measurement using the validated Likert sleep scale (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.