Chronic InsomniaPhase 4CIS2NCT02456532
Safety and Efficacy of Chronic Hypnotic Use 2
A Phase 4 study testing Zolpidem CR and Eszopiclone in people with Chronic Insomnia, run by Henry Ford Health System at 1 site in United States.
Trial summary
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Zolpidem CR and Eszopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2015to 22 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of insomnia
Who cannot join
- acute or unstable medical disease,
- current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risks for Transition From Therapeutic Hypnotic Use to Abuse
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.
Read the detailed description
Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.
- Conditions
- Chronic Insomnia
- Being tested
- placebo, Zolpidem CR, Eszopiclone
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
six months of nightly placebo
Zolpidem CRDrug
Also called Ambian CR
six months of nightly zolpidem
EszopicloneDrug
Also called Lunesta
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention: Six months of nightly placebo Receives: Drug: placebo |
| Zolpidem CR | Active comparator | Intervention: Six months of zolpidem cr 12.5 mg nightly use Receives: Drug: Zolpidem CR |
| Eszopiclone | Active comparator | Intervention: Six months of eszopiclone 3 mg nightly use Receives: Drug: Eszopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary
Measured: total number of capsules chosen in week 1 and week 2 of the discontinuation period
Secondary outcomes (1)
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period
comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period
Measured: mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study start5 Aug 2015
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Roehrs, PhD, Henry Ford Health System
- Investigators
- Timothy A Roehrs, PhD, Principal investigator, Henry Ford Health System Sleep Disorders Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456532
- Sponsor's protocol ID
- #9384
- Acronym
- CIS2
- Status last verified
- Jul 2023
- First submitted
- 6 May 2015
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks for Transition From Therapeutic Hypnotic Use to Abuse
- ClinicalTrials.gov ID
- NCT02456532
- Acronym / sponsor ID
- CIS2 / #9384
- Conditions
- Chronic Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 5 Aug 2015 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.
Detailed description
Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboIntervention: Six months of nightly placebo |
| Zolpidem CR | Active comparator | Drug: Zolpidem CRIntervention: Six months of zolpidem cr 12.5 mg nightly use |
| Eszopiclone | Active comparator | Drug: EszopicloneIntervention: Six months of eszopiclone 3 mg nightly use |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-5 diagnosis of insomnia
Key exclusion criteria (2 listed)
- acute or unstable medical disease,
- current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
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 |
|---|---|---|
| placebosix months of nightly placebo | Drug | Placebo |
| Zolpidem CRAlso: Ambian CRsix months of nightly zolpidem | Drug | Zolpidem CR |
| EszopicloneAlso: Lunesta | Drug | Eszopiclone |
Primary outcome
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
Time frame: total number of capsules chosen in week 1 and week 2 of the discontinuation period
instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary
1 secondary outcome
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period
Time frame: mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Timothy A Roehrs, PhD principal investigator
Henry Ford Health System Sleep Disorders Ctr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem CR and Eszopiclone in people with Chronic Insomnia, run by Henry Ford Health System at 1 site in United States.
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 1 inclusion and 2 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 29 Mar 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period (time frame: total number of capsules chosen in week 1 and week 2 of the discontinuation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.