Recruiting

Hypnotic Discontinuation

Sponsor:

National Jewish Health

Code:

NCT06435520

Conditions

Insomnia

Hypnotic Dependence

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Digital Cognitive Behavioral Therapy

Structured Medication Tapering

Study Details

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.

Conditions

Insomnia

Hypnotic Dependence

Study ID

NCT06435520

Start date

Jan 1, 2025

Status verified date

Jan, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Digital cognitive behavioral therapy combined with structured medication tapering

dCBTI delivered in tandem with SMT during intervention phase.

experimental: Structured medication tapering alone

Structured medication tapering delivered alone with general sleep hygiene information.

Interventions

Digital Cognitive Behavioral Therapy

Adaptive cloud-based software delivering cognitive behavioral therapy tailored to the needs of the individual patient.

Structured Medication Tapering

A structured tapering of hypnotic (or other) medication to promote successful discontinuation by patients seeking to discontinue use.

Primary outcome measure

  • Hypnotic discontinuation rates [ Time Frame: Post-treatment at weeks 22 and 49 of participation ]
  • Insomnia remission rates [ Time Frame: Post-treatment at weeks 22 and 49 of participation ]

Central Contacts and Locations

Central contacts

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

More Information

Sponsor

National Jewish Health

Last update posted

Jan 23, 2026

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2026-01-23.