Status:
ACTIVE_NOT_RECRUITING
Use of Blinded Tapering for Hypnotic Discontinuation
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Hypnotic Dependence Among Those With Insomnia
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The study will employ a randomized longitudinal clinical trial design to evaluate the relative efficacy of a blinded hypnotic tapering protocol when used in combination with therapist delivered Cognit...
Detailed Description
Treatment-seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine (BZD) or...
Eligibility Criteria
Inclusion
- be currently using one or more BZD or newer BzRA hypnotics at bedtime for insomnia management;
- have been using one or more such agents at least 5 nights/week for at least the past 12 months;
- express interest in discontinuing hypnotic use and learning to manage their insomnia without medications;
- report one or more failed attempts to discontinue hypnotic use in the past;
- provide written consent to participate.
- have an insomnia severity index score \> 10 indicating at least mild insomnia symptoms without sleep medication
Exclusion
- an untreated, or unstable psychiatric disorder as suggested by current active symptoms or a medication regimen that has been changed within the past 2 months;
- a lifetime diagnosis of any psychotic or bipolar disorder
- an imminent risk for suicide
- evidence of alcohol or drug abuse (other than hypnotics) within the past year, since such abuse patterns suggest specialized substance abuse treatment may be indicated
- unstable or terminal physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia) or sleep disruptive medical condition
- current use of medications known to cause insomnia (e.g., corticosteroids)
- screening evidence of circadian rhythm sleep disorder (e.g., delayed sleep phase syndrome) or other sleep disorder (e.g. narcolepsy, idiopathic hypersomnolence, Rapid Eye Movement (REM) behavior disorder) for which CBTI would not represent optimal therapy
- habitual bedtimes later than 2:00 AM or rising times later than 10:00 AM;
- consuming \> 2 alcoholic beverages/day or any cannabis products at least 5 times/week
- pregnant women or mothers with care-taking responsibilities for infants due to the sleep-disruption caused by such circumstances
- clinical or polysomnographic evidence of undiagnosed and untreated restless legs syndrome (RLS), sleep apnea or periodic limb movements (PLMS) that require alternative therapies and would limit participants' responses to CBTI
Key Trial Info
Start Date :
December 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04050176
Start Date
December 16 2019
End Date
June 30 2026
Last Update
February 24 2025
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206