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The Role of Behavior Therapy Combined with Buprenorphine for the Treatment of Opioid Use Disorder

Award Number: R01DA054113
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2022
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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The Role of Behavior Therapy Combined with Buprenorphine for the Treatment of Opioid Use Disorder - Project Summary/Abstract The misuse of opioids has reached an epidemic level in the United States, with approximately 2 million people suffering from opioid use disorder and over 46,800 opioid overdose fatalities in 2019. Medication-based treatment for opioid use disorder—such as buprenorphine maintenance—is effective and can save lives, however, approximately half of people who receive buprenorphine do not adequately respond or drop out of treatment. In contrast to other substance use disorders, the addition of behavior therapy to buprenorphine has not consistently shown improvements in opioid use outcomes for opioid use disorder. Preliminary evidence suggests that not everyone may need the addition of behavior therapy to buprenorphine to reduce opioid use, but that certain subgroups of people may benefit from behavior therapy. The ability to understand heterogeneity in response to treatment for opioid use disorder is hampered by the need for very large sample sizes to test questions about moderators of treatment response. Understanding subgroup differences can ultimately inform personalized medicine approaches to the treatment of opioid use disorder. Our objective for this proposal is to answer urgent questions about subgroup responses to behavioral therapy by harmonizing data from 4 completed clinical trials of treatment for opioid use disorder. These NIDA-funded randomized trials each tested the efficacy of behavior therapy added to buprenorphine maintenance for opioid use disorder and include common data elements, allowing for their harmonization. Our project aims include: (1) to identify subgroups who respond to behavior therapy when added to buprenorphine maintenance for opioid use disorder, (2) to quantify the efficacy of behavior therapy for improving buprenorphine treatment retention, and (3) to quantify the efficacy of behavior therapy for functional outcomes. The results from this study will provide important information about who responds to behavior therapy and the effect of behavior therapy on non-opioid use endpoints. Our proposal will utilize well-validated longitudinal data analysis methods, including a rigorous approach to missing data. By using existing datasets, this proposal provides an efficient way to answer urgent questions about the treatment of opioid use disorder and provides significant added value to these trials. These findings can be immediately used to inform personalized approaches to treatment for opioid use disorder and will also contribute to understanding of the impact of behavior therapy on endpoints of interest to patients and families.


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 = $0 )
2026	2024	THE MCLEAN HOSPITAL CORPORATION	115 MILL ST	BELMONT	MA	02478	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	3	3/24/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $350,550 )
2024	2024	THE MCLEAN HOSPITAL CORPORATION	115 MILL ST	BELMONT	MA	02478	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	3	4/23/2024	NON-COMPETING CONTINUATION	$350,550
														Subtotal = $350,550

Issue Date FY: 2023 ( Subtotal = $350,550 )
2023	2023	MCLEAN HOSPITAL CORPORATION, THE	115 MILL ST	BELMONT	MA	02478	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	2	3/29/2023	NON-COMPETING CONTINUATION	$350,550
														Subtotal = $350,550

Issue Date FY: 2022 ( Subtotal = $350,550 )
2022	2022	MCLEAN HOSPITAL CORPORATION, THE	115 MILL ST	BELMONT	MA	02478	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	1	4/20/2022	NEW	$350,550
														Subtotal = $350,550

Grand Total All Awards = $1,051,650

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The Role of Behavior Therapy Combined with Buprenorphine for the Treatment of Opioid Use Disorder

Award Number: R01DA054113

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2022

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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