TY - JOUR
AU - T. J. Stopka
AU - D. C. Babineau
AU - E. B. Gibson
AU - C. E. Knott
AU - D. M. Cheng
AU - J. Villani
AU - J. M. Wai
AU - D. Blevins
AU - J. L. David
AU - D. A. Goddard-Eckrich
AU - M. R. Lofwall
AU - R. Massatti
AU - J. DeFiore-Hyrmer
AU - M. S. Lyons
AU - L. C. Fanucchi
AU - D. R. Harris
AU - J. Talbert
AU - L. Hammerslag
AU - D. Oller
AU - R. R. Balise
AU - D. J. Feaster
AU - W. Soares
AU - G. A. Zarkin
AU - L. Glasgow
AU - E. Oga
AU - J. McCarthy
AU - L. D'Costa
AU - R. Chahine
AU - S. Gomori
AU - N. Dalvi
AU - S. Shrestha
AU - C. Garner
AU - A. Shadwick
AU - P. Salsberry
AU - M. W. Konstan
AU - B. Freisthler
AU - J. Winhusen
AU - N. El-Bassel
AU - J. H. Samet
AU - S. L. Walsh
A1 - 
AB - IMPORTANCE: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. OBJECTIVE: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. INTERVENTION: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. MAIN OUTCOMES AND MEASURES: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. RESULTS: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.
AD - Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.; Research Triangle Institute, Research Triangle Park, North Carolina.; Department of Medicine, Boston Medical Center, Boston, Massachusetts.; Boston University School of Public Health, Boston, Massachusetts.; National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland.; Department of Psychiatry, Columbia University; Division on Substance Use Disorders, New York State Psychiatric Institute, New York.; College of Medicine, University of Kentucky Center on Drug and Alcohol Research, Lexington.; Ohio Department of Mental Health and Addiction Services, Columbus.; State of Ohio Board of Pharmacy, Columbus.; College of Medicine, Ohio State University, Columbus.; College of Pharmacy, University of Kentucky, Lexington.; Department of Public Health Sciences, University of Miami, Miami, Florida.; UMass Chan Medical School-Baystate, Springfield, Massachusetts.; Office of Prescription Monitoring and Drug Control, Massachusetts Department of Public Health, Boston.; RecoveryOhio, Office of Ohio Governor Mike DeWine, Columbus.; Health Behavior and Health Promotion, Ohio State University, Columbus.; Case Western Reserve University School of Medicine, Cleveland, Ohio.; University of Cincinnati College of Medicine, Cincinnati, Ohio.; Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center, Boston, Massachusetts.
AN - 38386322
BT - JAMA Netw Open
C5 - Opioids & Substance Use; Key & Foundational
CP - 2
DA - Feb 5
DO - 10.1001/jamanetworkopen.2024.0132
DP - NLM
ET - 20240205
IS - 2
JF - JAMA Netw Open
LA - eng
N2 - IMPORTANCE: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. OBJECTIVE: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. INTERVENTION: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. MAIN OUTCOMES AND MEASURES: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. RESULTS: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.
PY - 2024
SN - 2574-3805
SP - e240132
ST - Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial
T1 - Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial
T2 - JAMA Netw Open
TI - Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial
U1 - Opioids & Substance Use; Key & Foundational
U3 - 10.1001/jamanetworkopen.2024.0132
VL - 7
VO - 2574-3805
Y1 - 2024
ER -