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Safety and Efficacy of Chronic Hypnotic Use 2

NCT02456532 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-03-29

Study results available
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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.

Conditions

  • Chronic Insomnia

Interventions

DRUG

placebo

six months of nightly placebo

DRUG

Zolpidem CR

six months of nightly zolpidem

DRUG

Eszopiclone

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Timothy A Roehrs, PhD · Henry Ford Health System Sleep Disorders Ctr

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-05
Primary Completion
2022-02-22
Completion
2022-02-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456532 on ClinicalTrials.gov