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Study identifier: NCT06435520 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Enhancing Hypnotic Medication Discontinuation in Primary Care

Condition: Insomnia · Hypnotic Dependence  ·  Sponsor: National Jewish Health

PhasePhase 4
Planned participants430
Who can joinAll sexes, 21 Years to no upper limit
Healthy volunteersNo

About this study

Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care. Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care. In response to this need, the project aims to conduct a large randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms. Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation…

This description comes directly from the study's public registry record.

Talk to the study team

RJ Johnson, MA  ·  303-398-1058  ·  chp@njhealth.org

Always discuss trial participation with your own doctor first.

Locations (1)

National Jewish HealthDenver, Colorado, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06435520