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Non-Benzodiazepine Hypnotic

Zolpidem CR for Chronic Insomnia (CIS2 Trial)

Phase 4
Waitlist Available
Led By Timothy A Roehrs, PhD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of insomnia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total number of capsules chosen in week 1 and week 2 of the discontinuation period
Awards & highlights

CIS2 Trial Summary

This trial will study whether people with insomnia who are at risk for abuse will be more likely to abuse a drug with mood effects.

Eligible Conditions
  • Chronic Insomnia

CIS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CIS2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total number of capsules chosen in week 1 and week 2 of the discontinuation period
This trial's timeline: 3 weeks for screening, Varies for treatment, and total number of capsules chosen in week 1 and week 2 of the discontinuation period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
Secondary outcome measures
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period

CIS2 Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Zolpidem CRActive Control1 Intervention
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Group II: EszopicloneActive Control1 Intervention
Intervention: Six months of eszopiclone 3 mg nightly use
Group III: PlaceboPlacebo Group1 Intervention
Intervention: Six months of nightly placebo

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,841 Total Patients Enrolled
Timothy A Roehrs, PhDPrincipal InvestigatorHenry Ford Health System Sleep Disorders Ctr

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Chronic Hypnotic Use 2
Timothy Roehrs, PhD 2015. "Safety and Efficacy of Chronic Hypnotic Use 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02456532.
~4 spots leftby Apr 2025
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