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

Award Number: R01DA057266
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2028

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Enhancing Hypnotic Medication Discontinuation in Primary Care through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy - PROJECT SUMMARY/ABSTRACT Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use them. Although evidenced-based physician-supervised medication tapering (SMT) protocols have shown efficacy, such interventions have yet to be disseminated widely in primary care. Most primary care providers (PCPs) are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as cognitive behavioral insomnia therapy (CBTI), but such treatment is often difficult to access outside of specialty sleep centers. Given this gap between research and clinical practice, there is a pressing need to develop and validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary care. In response to PAR-20-183, This application has been carefully designed to address these issues. We will conduct a large randomized trial to compare the combined digital CBT (dCBTI)/SMT intervention, to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement. A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research network affiliated with the University of Colorado Medical School in Aurora, Colorado will serve as study participants. The main objective of the project is to compare the performance of dCBTI+SMT with SMT used alone for achieving hypnotic reduction/discontinuation and insomnia symptom improvement. In addition, we will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and system-level factors that may impact adoption, implementation and maintenance of the types of interventions tested. Findings from the effectiveness/implementation should help design future trials of implementation strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should these treatments prove effective in the current trial. We also will gather exploratory data to determine who responds best to dCBTI/SMT. This study will provide new and useful information about the feasibility, clinical utility, and patient-, provider-, and system-level acceptability of these interventions to manage insomnia and reduce/eliminate hypnotic use in primary care. This project should serve as a necessary first step toward the eventual dissemination of accessible, cost-effective strategies to manage a significant public health problem and improve the quality of life of millions of chronic users of controlled-substance sleep aids.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $526,276 )
2026	2026	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	000	3	1/30/2026	NON-COMPETING CONTINUATION	$473,648
2026	2026	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	001	3	2/6/2026	NON-COMPETING CONTINUATION	$52,628
														Subtotal = $526,276

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	000	2	7/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $538,289 )
2024	2024	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	001	2	7/3/2024	NON-COMPETING CONTINUATION	$538,289
2024	2023	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	000	1	5/14/2024	NEW	$0
														Subtotal = $538,289

Issue Date FY: 2023 ( Subtotal = $535,473 )
2023	2023	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	000	1	7/27/2023	NEW	$535,473
2023	2023	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Drug Use and Addiction Research Programs	001	1	9/6/2023	NEW	$0
														Subtotal = $535,473

Grand Total All Awards = $1,600,038

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

Award Number: R01DA057266

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2028

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