At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 41 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risks for Transition From Therapeutic Hypnotic Use to Abuse
In Brief
A Phase 4 clinical trial evaluating placebo, Zolpidem CR, and 1 other intervention for Chronic Insomnia. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionFeb 2022
TodayJul 2026
First PostedMay 28, 2015
Enrollment StartAug 5, 2015
Primary CompletionFeb 22, 2022
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.1 years ago
Interventions
placebodrug
six months of nightly placebo
Zolpidem CRdrug
six months of nightly zolpidem
Eszopiclonedrug