Safety and Efficacy of Chronic Hypnotic Use 2
CIS2
Risks for Transition From Therapeutic Hypnotic Use to Abuse
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedStudy Start
First participant enrolled
August 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedResults Posted
Study results publicly available
March 29, 2024
CompletedMarch 29, 2024
July 1, 2023
6.6 years
May 6, 2015
June 15, 2023
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period
mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period
Study Arms (3)
Placebo
PLACEBO COMPARATORIntervention: Six months of nightly placebo
Zolpidem CR
ACTIVE COMPARATORIntervention: Six months of zolpidem cr 12.5 mg nightly use
Eszopiclone
ACTIVE COMPARATORIntervention: Six months of eszopiclone 3 mg nightly use
Interventions
Eligibility Criteria
You may qualify if:
- DSM-5 diagnosis of insomnia
You may not qualify if:
- acute or unstable medical disease,
- current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HFHS Sleep Disorders Ctr
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Difficulty reaching proposed enrollment target: 41 of projected 120 participants completed the study- in part due to COVID. Study is to be considered preliminary
Results Point of Contact
- Title
- Timothy Roehrs
- Organization
- Henry Ford Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy A Roehrs, PhD
Henry Ford Health System Sleep Disorders Ctr
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Bioscientist
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 28, 2015
Study Start
August 5, 2015
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
March 29, 2024
Results First Posted
March 29, 2024
Record last verified: 2023-07