Skip to main content
OpenTrials
Completed

NCT Number: NCT02456532

Safety and Efficacy of Chronic Hypnotic Use 2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HFHS Sleep Disorders Ctr

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

six months of nightly placebo

Zolpidem CR

Drug

six months of nightly zolpidem

Other names: Ambian CR

Eszopiclone

Drug

Other names: Lunesta

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Risks for Transition From Therapeutic Hypnotic Use to Abuse

Acronym: CIS2

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 28, 2015
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.