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. 2024 Feb 5;7(2):e240132.
doi: 10.1001/jamanetworkopen.2024.0132.

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial

Thomas J Stopka  1 , Denise C Babineau  2 , Erin B Gibson  3 , Charles E Knott  2 , Debbie M Cheng  4 , Jennifer Villani  5 , Jonathan M Wai  6 , Derek Blevins  6 , James L David  6 , Dawn A Goddard-Eckrich  6 , Michelle R Lofwall  7 , Richard Massatti  8 , Jolene DeFiore-Hyrmer  9 , Michael S Lyons  10 , Laura C Fanucchi  7 , Daniel R Harris  11 , Jeffery Talbert  11 , Lindsey Hammerslag  7 , Devin Oller  7 , Raymond R Balise  12 , Daniel J Feaster  12 , William Soares  13 , Gary A Zarkin  2 , LaShawn Glasgow  2 , Emmanuel Oga  2 , John McCarthy  2 , Lauren D'Costa  2 , Rouba Chahine  2 , Steve Gomori  2 , Netrali Dalvi  14 , Shikhar Shrestha  1 , Chad Garner  9 , Aimee Shadwick  15 , Pamela Salsberry  16 , Michael W Konstan  17 , Bridget Freisthler  10 , John Winhusen  18 , Nabila El-Bassel  6 , Jeffrey H Samet  3   19 , Sharon L Walsh  7
Affiliations

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial

Thomas J Stopka et al. JAMA Netw Open. .

Erratum in

  • Errors in Definitions Used by Research Sites.
    [No authors listed] [No authors listed] JAMA Netw Open. 2024 Aug 1;7(8):e2433598. doi: 10.1001/jamanetworkopen.2024.33598. JAMA Netw Open. 2024. PMID: 39158918 Free PMC article. No abstract available.

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Stopka and Babineau reported receiving grants from the National Institute on Drug Abuse (NIDA) during the conduct of the study. Ms Gibson reported receiving grants from the NIDA and Substance Abuse and Mental Health Services Administration during the conduct of the study. Dr Cheng reported receiving grants from the NIDA during the conduct of the study. Dr Wai reported receiving grants from the National Institute on Alcohol Abuse and Alcoholism during the conduct of the study; and grants from Substance Abuse and Mental Health Services Administration (SAMHSA) from Department of Defense US Army Medical Research Acquisition Activity outside the submitted work. Dr Blevins reported receiving personal fees from Pear Therapeutics Inc outside the submitted work. Dr Lofwall reported receiving consultant fees from Berkshire Biomedical Research, Braeburn Research, Journey Colab Research, and Titan Pharmaceuticals outside the submitted work. Mrs DeFiore-Hyrmer reported receiving grants from the US Department of Justice, Bureau of Justice Assistance. Dr Lyons reported receiving grants from the National Institutes of Health (NIH) Substance Abuse and Mental Health Services Administration HEALing Communities Study during the conduct of the study. Dr Fanucchi reported grants from the NIH during the conduct of the study. Dr Feaster reported receiving grants from the NIDA during the conduct of the study. Dr Glasgow reported receiving grants from the NIDA. Dr Chahine reported receiving grants from the NIH and SAMHSA during the conduct of the study. Dr Shadwick reported receiving salary from the Ohio Department of Mental Health and Addiction Services Salary during the conduct of the study, and being the RecoveryOhio Director in the Office of Governor Mike DeWine. Dr Salsberry reported receiving grants from the NIDA during the conduct of the study. Dr Konstan reported receiving grants from the NIH during the conduct of the study. Dr Freisthler reported receiving grants from the NIDA during the conduct of the study. Dr Samet reported receiving grants from the NIH during the conduct of the study. Dr Walsh reported receiving grants from the NIDA during the conduct of the study and personal fees from Braeburn Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Titan Pharmaceuticals, and Opiant outside the submitted work; in addition, Dr Walsh had a patent for Tradipitant #62682831 issued by the University of Kentucky and Vanda Pharmaceuticals. No other disclosures were reported.

Figures

Figure.
Figure.. Flow Diagram of the HEALing Communities Study in Kentucky, Massachusetts, New York, and Ohio
See this image and copyright information in PMC

References

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