Enhancing Hypnotic Medication Discontinuation in Primary Care
1 other identifier
interventional
430
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2025
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
January 23, 2026
January 1, 2025
3.5 years
May 15, 2024
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Hypnotic discontinuation rates
Rates of successful hypnotic discontinuation among participants
Post-treatment at weeks 22 and 49 of participation
Insomnia remission rates
Rates of insomnia remission among participants
Post-treatment at weeks 22 and 49 of participation
Study Arms (2)
Digital cognitive behavioral therapy combined with structured medication tapering
EXPERIMENTALdCBTI delivered in tandem with SMT during intervention phase.
Structured medication tapering alone
EXPERIMENTALStructured medication tapering delivered alone with general sleep hygiene information.
Interventions
Adaptive cloud-based software delivering cognitive behavioral therapy tailored to the needs of the individual patient.
A structured tapering of hypnotic (or other) medication to promote successful discontinuation by patients seeking to discontinue use.
Eligibility Criteria
You may qualify if:
- a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications;
- a desire to decrease/eliminate hypnotic use;
- a history of insomnia that meets DSM-560 criteria for insomnia disorder; and
- willingness to provide written informed consent to participate.
You may not qualify if:
- a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder;
- presence of an unstable, untreated, or terminal major medical or psychiatric disorder;
- alcohol or drug abuse within the past year;
- current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder);
- pregnancy;
- significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE);
- current use of medications known to cause insomnia (e.g., high dose corticosteroids);
- untreated comorbid sleep disorders;
- use of a sedating antidepressant or antipsychotic medication solely for sleep; and
- consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Jewish Health
Denver, Colorado, 80206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2024
First Posted
May 30, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
January 23, 2026
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
Not planned.