Safety and Efficacy of Chronic Hypnotic Use 2

NCT ID: NCT02456532

Last Updated: 2024-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-05

Study Completion Date

2022-02-22

Brief Summary

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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

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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

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Intervention: Six months of nightly placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

six months of nightly placebo

Zolpidem CR

Intervention: Six months of zolpidem cr 12.5 mg nightly use

Group Type ACTIVE_COMPARATOR

Zolpidem CR

Intervention Type DRUG

six months of nightly zolpidem

Eszopiclone

Intervention: Six months of eszopiclone 3 mg nightly use

Group Type ACTIVE_COMPARATOR

Eszopiclone

Intervention Type DRUG

Interventions

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placebo

six months of nightly placebo

Intervention Type DRUG

Zolpidem CR

six months of nightly zolpidem

Intervention Type DRUG

Eszopiclone

Intervention Type DRUG

Other Intervention Names

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Ambian CR Lunesta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Timothy Roehrs, PhD

Senior Bioscientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy A Roehrs, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System Sleep Disorders Ctr

Locations

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HFHS Sleep Disorders Ctr

Detroit, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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#9384

Identifier Type: -

Identifier Source: org_study_id

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