CIS2: Safety and Efficacy of Chronic Hypnotic Use 2

Sponsor

Henry Ford Health System (Other)

Overall Status

Completed

CT.gov ID

NCT02456532

Collaborator

(none)

Enrollment

Location

Arms

79.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

42 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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change in number capsules chosen: nightly choice of 0, 1, 2, or 3 capsules [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 [last two weeks of month 6]
instruction to stop nightly hypnotic use

Secondary Outcome Measures

change in actigraphic determined sleep time [first two weeks of months 1, 3, and 6]
comparing the three treatment arms for hypnotic efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HFHS Sleep Disorders Ctr	Detroit	Michigan	United States	48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

Principal Investigator: Timothy A Roehrs, PhD, Henry Ford Health System Sleep Disorders Ctr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy Roehrs, PhD, Senior Bioscientist, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT02456532

Other Study ID Numbers:

#9384

First Posted:

May 28, 2015

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Zolpidem

Eszopiclone

Study Results

No Results Posted as of Aug 24, 2022