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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. Identifier: NCT02456532
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : April 6, 2021
Information provided by (Responsible Party):
Timothy Roehrs, PhD, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: placebo Drug: Zolpidem CR Drug: Eszopiclone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Risks for Transition From Therapeutic Hypnotic Use to Abuse
Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Intervention: Six months of nightly placebo
Drug: placebo
Active Comparator: Zolpidem CR
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Drug: Zolpidem CR
Active Comparator: Eszopiclone
Intervention: Six months of eszopiclone 3 mg nightly use
Drug: Eszopiclone

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02456532

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Contact: Gail Koshorek, BS 313-916-5179

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United States, Michigan
HFHS Sleep Disorders Ctr Recruiting
Detroit, Michigan, United States, 48202
Contact: Gail Koshorek, BS    313-916-5179   
Contact: Dana Withrow, MHA    313-916-5302   
Sponsors and Collaborators
Henry Ford Health System
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Principal Investigator: Timothy A Roehrs, PhD Henry Ford Health System Sleep Disorders Ctr
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Responsible Party: Timothy Roehrs, PhD, Senior Bioscientist, Henry Ford Health System Identifier: NCT02456532    
Other Study ID Numbers: #9384
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action