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Safety and Efficacy of Chronic Hypnotic Use 2 (CIS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02456532
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Timothy Roehrs, PhD, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 28, 2015
Last Update Posted Date August 15, 2019
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules [ Time Frame: last two weeks of month1 and 3 ]
    total possible nightly dose limited to upper clinical dose
  • discontinuation difficulty: nightly choice of 0, 1, 2, or 3 capsules [ Time Frame: last two weeks of month 6 ]
    instruction to stop nightly hypnotic use
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
change in actigraphic determined sleep time [ Time Frame: first two weeks of months 1, 3, and 6 ]
comparing the three treatment arms for hypnotic efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Chronic Hypnotic Use 2
Official Title  ICMJE Risks for Transition From Therapeutic Hypnotic Use to Abuse
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE
  • Drug: placebo
  • Drug: Zolpidem CR
  • Drug: Eszopiclone
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Six months of nightly placebo
    Intervention: Drug: placebo
  • Active Comparator: Zolpidem CR
    Intervention: Six months of zolpidem cr 12.5 mg nightly use
    Intervention: Drug: Zolpidem CR
  • Active Comparator: Eszopiclone
    Intervention: Six months of eszopiclone 3 mg nightly use
    Intervention: Drug: Eszopiclone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gail Koshorek, BS 313-916-5179 gkoshor1@hfhs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02456532
Other Study ID Numbers  ICMJE #9384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy Roehrs, PhD, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy A Roehrs, PhD Henry Ford Health System Sleep Disorders Ctr
PRS Account Henry Ford Health System
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP