Patient-centered methadone treatment: a randomized clinical trial

Robert P. Schwartz; Sharon M. Kelly; Shannon G. Mitchell; Jan Gryczynski; Kevin E. O'Grady; Devang Gandhi; Yngvild Olsen; Jerome H. Jaffe

doi:10.1111/add.13622

Patient-centered methadone treatment: a randomized clinical trial

Robert P. Schwartz, Sharon M. Kelly, Shannon G. Mitchell, Jan Gryczynski, Kevin E. O'Grady, Devang Gandhi, Yngvild Olsen, Jerome H. Jaffe

School of Medicine

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Background and Aims: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. Design: Two-arm open-label randomized trial. Setting: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. Participants: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. Intervention: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). Measurements: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. Findings: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). Conclusions: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.

Original language	English (US)
Pages (from-to)	454-464
Number of pages	11
Journal	Addiction
Volume	112
Issue number	3
DOIs	https://doi.org/10.1111/add.13622
State	Published - Mar 1 2017

Keywords

Methadone treatment
opioid substitution therapy
opioid use disorder
patient-centered care
therapeutic alliance
treatment retention

ASJC Scopus subject areas

Medicine (miscellaneous)
Psychiatry and Mental health

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10.1111/add.13622

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@article{961be6fb1b5546c1ae27888fda5c5dd4,

title = "Patient-centered methadone treatment: a randomized clinical trial",

abstract = "Background and Aims: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. Design: Two-arm open-label randomized trial. Setting: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. Participants: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. Intervention: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). Measurements: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. Findings: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). Conclusions: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.",

keywords = "Methadone treatment, opioid substitution therapy, opioid use disorder, patient-centered care, therapeutic alliance, treatment retention",

author = "Schwartz, {Robert P.} and Kelly, {Sharon M.} and Mitchell, {Shannon G.} and Jan Gryczynski and O'Grady, {Kevin E.} and Devang Gandhi and Yngvild Olsen and Jaffe, {Jerome H.}",

note = "Funding Information: We wish to thank the staff at University of Maryland and REACH MTPs, the study's research assistants and the patient participants, without whom this research would not have been possible. This study was supported through National Institute on Drug Abuse (NIDA) Grant no. 2R01DA15842 (Principal Investigator Robert P. Schwartz). NIDA or the National Institutes of Health had no role in the design and conduct of the study; data acquisition, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIDA or the National Institutes of Health. Publisher Copyright: {\textcopyright} 2016 Society for the Study of Addiction",

year = "2017",

month = mar,

day = "1",

doi = "10.1111/add.13622",

language = "English (US)",

volume = "112",

pages = "454--464",

journal = "Addiction",

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T1 - Patient-centered methadone treatment

T2 - a randomized clinical trial

AU - Schwartz, Robert P.

AU - Kelly, Sharon M.

AU - Mitchell, Shannon G.

AU - Gryczynski, Jan

AU - O'Grady, Kevin E.

AU - Gandhi, Devang

AU - Olsen, Yngvild

AU - Jaffe, Jerome H.

N1 - Funding Information: We wish to thank the staff at University of Maryland and REACH MTPs, the study's research assistants and the patient participants, without whom this research would not have been possible. This study was supported through National Institute on Drug Abuse (NIDA) Grant no. 2R01DA15842 (Principal Investigator Robert P. Schwartz). NIDA or the National Institutes of Health had no role in the design and conduct of the study; data acquisition, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIDA or the National Institutes of Health. Publisher Copyright: © 2016 Society for the Study of Addiction

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Background and Aims: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. Design: Two-arm open-label randomized trial. Setting: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. Participants: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. Intervention: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). Measurements: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. Findings: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). Conclusions: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.

AB - Background and Aims: Methadone patients who discontinue treatment are at high risk of relapse, yet a substantial proportion discontinue treatment within the first year. We investigated whether a patient-centered approach to methadone treatment improved participant outcomes at 12 months following admission, compared with methadone treatment-as-usual. Design: Two-arm open-label randomized trial. Setting: Two methadone treatment programs (MTPs) in Baltimore, MD, USA. Participants: Three hundred newly admitted MTP patients were enrolled between 13 September 2011 and 26 March 2014. Their mean age was 42.7 years [standard deviation (SD) = 10.1] and 59% were males. Intervention: Newly admitted MTP patients were assigned randomly to either patient-centered methadone treatment (PCM; n = 149), which modified the MTP's rules (e.g. counseling attendance was optional), and counselor roles (e.g. counselors were not responsible for enforcing clinic rules) or treatment-as-usual (TAU; n = 151). Measurements: The primary outcome was opioid-positive urine test at 12-month follow-up. Other 12-month outcomes included days of heroin and cocaine use, cocaine-positive urine tests, meeting DSM-IV opioid and cocaine dependence diagnostic criteria, HIV risk behavior and quality of life and retention in treatment. Findings: There was no significant difference between PCM and TAU conditions in opioid-positive urine screens at 12 months [adjusted odds ratio = 0.98; 95% confidence interval (CI) = 0.61, 1.56]. There were also no significant differences in any of the secondary outcome measures (all Ps > 0.05) except Quality of Life Global Score (P = 0.04; 95% CI = 0.01, 0.45). There were no significant differences between conditions in the number of individual or group counseling sessions attended. (Ps > 0.05). Conclusions: Patient-centered methadone treatment (with optional counseling and the counselor not serving as the treatment program disciplinarian) does not appear to be more effective than methadone treatment-as-usual.

KW - Methadone treatment

KW - opioid substitution therapy

KW - opioid use disorder

KW - patient-centered care

KW - therapeutic alliance

KW - treatment retention

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Patient-centered methadone treatment: a randomized clinical trial

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