Safety and Efficacy of Chronic Hypnotic Use 2

Chronic Insomnia Clinical Trial

— CIS2  

Official title:

Risks for Transition From Therapeutic Hypnotic Use to Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456532
• Other study ID #: #9384
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2015
• Est. completion date: February 22, 2022

Study information

• Verified date: July 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• placebo
six months of nightly placebo
• Zolpidem CR
six months of nightly zolpidem
• Eszopiclone

Locations

Country	Name	City	State
United States	HFHS Sleep Disorders Ctr	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period	instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary	total number of capsules chosen in week 1 and week 2 of the discontinuation period
Secondary	Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period	comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period	mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period