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Principal Investigator: Rebecca Kathryn McHugh
Organization: MCLEAN HOSPITAL
Fiscal Year: 2024
Award: $350,550
Funding agency: National Institute on Drug Abuse
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.
Terms: <Address><Age><Area><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Buprenorphine><Clinical><Clinical Treatment><Clinical Trials><Cognition Therapy><Cognitive Psychotherapy><Cognitive Therapy><Cognitive treatment><Combined Modality Therapy><Common Data Element><Conditioning Therapy><Counseling><Data><Data Analyses><Data Analysis><Data Set><Decision Making><Drops><Drug Screening><Drugs><Employment><Engineering><Epidemic><Family><Functional impairment><Funding><Future><Heterogeneity><Impairment><Individual><Knowledge><Legal><Maintenance><Manuals><Measures><Medication><Medicine><Mental disorders><Mental health disorders><Methodology><Methods><Multimodal Therapy><Multimodal Treatment><NIDA><National Academy of Sciences><National Institute of Drug Abuse><National Institute on Drug Abuse><Opiates><Opioid><Opioid Analgesics><Outcome><Participant><Patient Self-Report><Patients><Personalized medical approach><Persons><Pharmaceutical Preparations><Psychiatric Disease><Psychiatric Disorder><Public Health><Randomization trial><Relapse><Reporting><Research><Review Literature><Role><Sample Size><Sampling><Self-Report><Structure><Subgroup><Substance Use Disorder><Testing><United States><United States National Academy of Sciences><Update><Urine><Work><ages><behavior intervention><behavioral intervention><buprenorphine treatment><chronic pain><clinical care><cocaine use><cognitive behavior intervention><cognitive behavior modification><cognitive behavior therapy><cognitive behavioral intervention><cognitive behavioral modification><cognitive behavioral therapy><cognitive behavioral treatment><combination therapy><combined modality treatment><combined treatment><data harmonization><data interpretation><drug/agent><effective therapy><effective treatment><efficacy testing><functional improvement><functional outcomes><harmonized data><heroin intake><heroin use><improve function><improved><improved functional outcomes><individualized approach><innovate><innovation><innovative><interest><medication for opioid use disorder><mental illness><multi-modal therapy><multi-modal treatment><non-medical opioid use><non-narcotic analgesic><non-opiate analgesic><non-opioid><non-opioid analgesic><non-opioid therapeutics><nonmedical opioid use><nonnarcotic analgesics><nonopiate analgesic><nonopioid><nonopioid analgesics><novel><opiate analgesia><opiate analgesic><opiate consumption><opiate crisis><opiate drug use><opiate intake><opiate misuse><opiate overdose><opiate pain medication><opiate pain reliever><opiate related overdose><opiate use><opiate use disorder><opioid analgesia><opioid anesthetic><opioid consumption><opioid crisis><opioid drug overdose><opioid drug use><opioid epidemic><opioid induced overdose><opioid intake><opioid intoxication><opioid medication overdose><opioid misuse><opioid overdose><opioid pain medication><opioid pain reliever><opioid painkiller><opioid poisoning><opioid related overdose><opioid toxicity><opioid use><opioid use disorder><overdose death><overdose fatalities><patient subclass><patient subcluster><patient subgroups><patient subpopulations><patient subsets><patient subtypes><personalization of treatment><personalized approach><personalized medicine><personalized therapy><personalized treatment><precision approach><predict responsiveness><predicting response><primary outcome><psychiatric illness><psychological disorder><randomized trial><randomized, clinical trials><response><response to therapy><response to treatment><secondary analysis><social role><substance use><substance use and disorder><substance using><systematic review><tailored approach><therapeutic response><therapy response><treatment effect><treatment response><treatment responsiveness><trial regimen><trial treatment>