Helping patients reduce reliance on sleep medications in primary care

Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy

This study is testing a new way to help people with insomnia safely cut back on sleep medications by using a combination of online therapy and a plan to reduce their medication, compared to regular care.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 430 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National Jewish Health (Academic / other)
• Locations: 1 site (Denver, Colorado)
• Trial ID: NCT06435520 on ClinicalTrials.gov

What this trial studies

This project aims to address the challenge of hypnotic medication dependence among insomnia sufferers in primary care settings. It will conduct a large randomized trial comparing a combined digital cognitive behavioral therapy (dCBTI) and structured medication tapering intervention against standard care. The goal is to validate a cost-effective approach that helps patients safely reduce or discontinue their use of hypnotics while managing their insomnia effectively. By bridging the gap between research and clinical practice, this study seeks to improve patient outcomes in managing insomnia.

Who should consider this trial

Good fit: Ideal candidates are individuals with a history of extended use of hypnotic medications for insomnia who wish to decrease or eliminate their use.

Not a fit: Patients with severe psychiatric disorders, significant cognitive impairment, or those currently using hypnotics for other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the reliance on hypnotic medications and improve sleep quality for patients with insomnia.

How similar studies have performed: Previous studies have shown promise in using cognitive behavioral therapy and medication tapering for insomnia, indicating that this approach could be effective.

Eligibility criteria

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.

Where this trial is running

Denver, Colorado

• National Jewish Health — Denver, Colorado, United States (Recruiting)

Study contacts

• Study coordinator: RJ Johnson, MA

Conditions Insomnia; Hypnotic Dependence