Clinical Trials Logo
  1. Home
  2. Chronic Insomnia
  3. NCT02456532

Safety and Efficacy of Chronic Hypnotic Use 2 — CIS2  

Chronic Insomnia Clinical Trial

Official title:
Risks for Transition From Therapeutic Hypnotic Use to Abuse

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02456532
Study type Interventional
Source Henry Ford Health System
Contact
Status Completed
Phase Phase 4
Start date August 5, 2015
Completion date February 22, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03171519 - Effects of Exercise and Acupuncture on Chronic Insomnia N/A
Completed NCT02515006 - Impact of Homeopathy for Persistent Insomnia in Patients With Cancer N/A
Recruiting NCT05247697 - Mirtazapine for Chronic Insomnia in Older Adults Phase 1
Active, not recruiting NCT04350866 - Enhancing Access to Insomnia Care in VA PCMHI Clinics
Active, not recruiting NCT04366284 - Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform N/A
Recruiting NCT04761796 - Sleep Time and Insomnia Factors Among Professional Flight Members
Completed NCT02688569 - Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study N/A
Completed NCT02236845 - Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients N/A
Completed NCT01949389 - Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders N/A
Completed NCT00414102 - Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia. Phase 4
Completed NCT00671294 - Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia. Phase 3
Completed NCT02392000 - Mobile Sleep Intervention for OEF, OIF and OND Veterans N/A
Recruiting NCT04471168 - Interest of Auriculotherapy in the Management of Chronic Insomnia N/A
Completed NCT02774642 - Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study) N/A
Completed NCT02290405 - Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Completed NCT05618002 - Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
Completed NCT01995838 - A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia Phase 2
Recruiting NCT05457790 - Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD) N/A
Completed NCT02272712 - The Effectiveness of Online Treatment for Insomnia in Cancer Survivors N/A
Completed NCT00915135 - Efficacy and Safety of Ramelteon on Chronic Insomnia Phase 2