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Sleep Without Insomnia or The Use of Chronic Hypnotics

About

Brief Summary

Sleeping medications, called hypnotics, are often prescribed for insomnia and are associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving "placebo" effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. In this study, investigators are comparing two programs for discontinuing hypnotic medications-a program that addresses placebo effects associated with hypnotic use and a program that does not address these effects.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
55 Years
Maximum Age
N/A

Inclusion Criteria:

  • Age >= 55 years
  • Use of lorazepam, alprazolam, temazepam,and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
  • Current or prior insomnia symptoms
  • Available to attend weekly in-person sessions over 9 weeks

Exclusion Criteria:

High risk for complications in outpatient hypnotic discontinuation program:

  • Seizure disorder
  • Supratherapeutic or high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night).
  • High baseline risk of complicated withdrawal;benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g.,seizure, delirium at baseline (prior to taper))
  • Polydrug use (e.g., chronic high dose opioids)
  • Unable to keep study medications in secure location
  • Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at multiple pharmacies during overlapping time periods, diversion) Discontinuation of hypnotic not appropriate: -Study-targeted hypnotic used to treat another clinical condition (e.g., panic disorder) Poor candidate for cognitive behavioral therapy for insomnia:
  • Presence of bipolar disorder
  • Cognitive impairment (e.g., Mini-Mental State Examination < 24)
  • Sleep/wake difficulty is better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders
  • Untreated sleep-disordered breathing (respiratory event index >= 15 and < 30 plus excessive daytime sleepiness, or REI >=30)
  • Medically/psychiatrically unstable (e.g., planned major surgery during the study period;psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
  • Unstable housing situation

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Study Stats
Protocol No.
18-001009
Category
Medicine-Va Wadsworth Medical Center
Principal Investigator
CONSTANCE FUNG
Contact
Sara Ghadimi
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03687086
For detailed technical eligibility, visit ClinicalTrials.gov.