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.
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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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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