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Fiellin DA, O'Connor PG, Chawarski M, Pakes JP, Pantalon MV, Schottenfeld RS. Methadone Maintenance in Primary Care: A Randomized Controlled Trial. JAMA. 2001;286(14):1724–1731. doi:https://doi.org/10.1001/jama.286.14.1724
Author Affiliations: Departments of Internal Medicine (Drs Fiellin and O'Connor) and Psychiatry (Drs Chawarski, Pantalon, and Schottenfeld), Yale University School of Medicine, New Haven, Conn; and the Department of Health Care Policy, Harvard Medical School, Boston, Mass (Ms Pakes).
Context Methadone maintenance is an effective treatment for opioid dependence,
yet its use is restricted to federally licensed narcotic treatment programs
(NTPs). Office-based care of stabilized methadone maintenance patients is
a promising alternative but no data are available from controlled trials regarding
this type of program.
Objective To determine the feasibility and efficacy of office-based methadone
maintenance by primary care physicians vs in an NTP for stable opioid-dependent
Design Six-month, randomized controlled open clinical trial conducted February
Setting Offices of 6 primary care internists and an NTP.
Patients Forty-seven opioid-dependent patients who had been receiving methadone
maintenance therapy in an NTP without evidence of illicit drug use for 1 year
and without significant untreated psychiatric comorbidity were randomized;
1 patient refused to participate after treatment assignment to NTP.
Interventions Patients were randomly assigned to receive office-based methadone maintenance
from primary care physicians, who received specialized training in the care
of opioid-dependent patients (n = 22), or usual care at an NTP (n = 24).
Main Outcome Measures Illicit drug use, clinical instability (persistent drug use), patient
and clinician satisfaction, functional status, and use of health, legal, and
social services, compared between the 2 groups.
Results Eleven of 22 (50%; 95% confidence interval [CI], 29%-71%) patients in
office-based care compared with 9 of 24 (38%; 95% CI, 21%-57%) of NTP patients
had a self-report or urine toxicology test result indicating illicit opiate
use (P = .39). Hair toxicology testing detected an
additional 2 patients in each treatment group with evidence of illicit drug
use, but this did not change the overall findings. Ongoing illicit drug use
meeting criteria for clinical instability occurred in 4 of 22 (18%; 95% CI,
7%-39%) patients in office-based care compared with 5 of 24 (21%; 95% CI,
9%-41%) NTP patients (P = .82). Sixteen of the 22
(73%; 95% CI, 54%-92%) office-based patients compared with 3 of the 24 (13%;
95% CI, 0%-26%) NTP patients thought the quality of care was excellent (P = .001). There were no differences over time within or
between groups in functional status or use of health, legal, or social services.
Conclusions Our results support the feasibility and efficacy of transferring stable
opioid-dependent patients receiving methadone maintenance to primary care
physicians' offices for continuing treatment and suggest guidelines for identifying
patients and clinical monitoring.
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