Back to resultsSafety and Efficacy of Chronic Hypnotic Use 2 (CIS2)
Primary Purpose
Chronic Insomnia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placebo
Zolpidem CR
Eszopiclone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia
Eligibility Criteria
Inclusion Criteria:
- DSM-5 diagnosis of insomnia
Exclusion Criteria:
- acute or unstable medical disease,
- current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Sites / Locations
- HFHS Sleep Disorders Ctr
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Zolpidem CR
Eszopiclone
Arm Description
Intervention: Six months of nightly placebo
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Intervention: Six months of eszopiclone 3 mg nightly use
Outcomes
Primary Outcome Measures
change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules
total possible nightly dose limited to upper clinical dose
discontinuation difficulty: nightly choice of 0, 1, 2, or 3 capsules
instruction to stop nightly hypnotic use
Secondary Outcome Measures
change in actigraphic determined sleep time
comparing the three treatment arms for hypnotic efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456532
Brief Title
Safety and Efficacy of Chronic Hypnotic Use 2
Acronym
CIS2
Official Title
Risks for Transition From Therapeutic Hypnotic Use to Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
February 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Six months of nightly placebo
Arm Title
Zolpidem CR
Arm Type
Active Comparator
Arm Description
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Arm Title
Eszopiclone
Arm Type
Active Comparator
Arm Description
Intervention: Six months of eszopiclone 3 mg nightly use
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
Zolpidem CR
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Primary Outcome Measure Information:
Title
change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules
Description
total possible nightly dose limited to upper clinical dose
Time Frame
last two weeks of month1 and 3
Title
discontinuation difficulty: nightly choice of 0, 1, 2, or 3 capsules
Description
instruction to stop nightly hypnotic use
Time Frame
last two weeks of month 6
Secondary Outcome Measure Information:
Title
change in actigraphic determined sleep time
Description
comparing the three treatment arms for hypnotic efficacy
Time Frame
first two weeks of months 1, 3, and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
DSM-5 diagnosis of insomnia
Exclusion Criteria:
acute or unstable medical disease,
current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy A Roehrs, PhD
Organizational Affiliation
Henry Ford Health System Sleep Disorders Ctr
Official's Role
Principal Investigator
Facility Information:
Facility Name
HFHS Sleep Disorders Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Chronic Hypnotic Use 2
We'll reach out to this number within 24 hrs