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Enhancing Hypnotic Medication Discontinuation in Primary Care

Key facts

Who runs it
National Jewish Health
Where
Denver, United StatesSee the site
Trial code
Status
Recruiting
People taking part
250 people, planned
Started
1 Jan 2025
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Digital Cognitive Behavioral Therapy
  • Structured Medication Tapering
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Who cannot take part

  • Appendix A: Eligible Medications
  • Zolpidem (Ambien, Ambien CR)
  • Lorazepam (Ativan)
  • Clonazepam (Klonopin)
  • Eszopiclone (Lunesta)
  • Temazepam (Restoril)
  • Zaleplon (Sonata)
  • Alprazolam (Xanax)
  • Diazepam (Valium)
  • Trazodone (Desyrel)
  • Doxepin (Silenor)
  • Quetiapine (Seroquel), ≤100mg only
  • Mirtazapine (Remeron)
  • Hydroxyzine (Vistaril)
  • Doxepin (Silenor)
  • Prazepam (Centrax)
  • Flurazepam (Dalmane)
  • Quazepam (Doral)
  • Triazolam (Halcion)
  • Cholordiazepoxide (Librium)
  • Halazepam (Paxipam)
  • Estazolam (Prosom)
  • Oxazepam (Serax)
  • Clorazepate (Tranxene)

Where in United States

  • National Jewish HealthDenver, United StatesContact: RJ JohnsonTaking people

About the trial

What the trial wants to find out

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 or other medical clinics.

Read full original descriptionShow less

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 250 patients reliant on hypnotics across collaborating clinics and the general public . 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 medical settings. 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.

The 2 groups in the trial

  • Digital cognitive behavioral therapy combined with structured medication taperingTreatment being tested

    dCBTI delivered in tandem with SMT during intervention phase.

    Treatment: Digital Cognitive Behavioral Therapy and Structured Medication Tapering

  • Structured medication tapering aloneTreatment being tested

    Structured medication tapering delivered alone with general sleep hygiene information.

    Treatment: Structured Medication Tapering

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy
Record updated
12 November 2026