Actively Recruiting

Phase 4
Age: 21Years +
All Genders
NCT06435520

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

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here