Actively Recruiting
Enhancing Hypnotic Medication Discontinuation in Primary Care
Led by National Jewish Health · Updated on 2026-01-23
430
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 strategies to disseminate effective treatments in primary care. Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improve the quality of life for millions of chronic users of sleep aids.
CONDITIONS
Official Title
Enhancing Hypnotic Medication Discontinuation in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of using benzodiazepine or non-benzodiazepine hypnotic medications for more than 6 consecutive months and more than 5 nights per week on average
- Desire to decrease or eliminate hypnotic medication use
- Diagnosis of insomnia disorder according to DSM-5 criteria
- Willingness to provide written informed consent to participate
You will not qualify if you...
- Lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder
- Presence of unstable, untreated, or terminal major medical or psychiatric disorders
- Alcohol or drug abuse within the past year
- Current use of benzodiazepine for disorders other than insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder)
- Pregnancy
- Significant cognitive impairment indicated by a Mini-Mental State Examination score of 24 or less
- Current use of medications known to cause insomnia, such as high-dose corticosteroids
- Untreated comorbid sleep disorders
- Use of sedating antidepressant or antipsychotic medication solely for sleep
- Consuming more than 2 alcoholic drinks per day at least 5 times per week or any use of marijuana at least 5 times per week
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
Research Team
R
RJ Johnson, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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