Methadone Medical Maintenance in Primary Care
An Implementation Evaluation
Joseph O. Merrill, MD, MPH,1,6T. Ron Jackson, MSW,2Beryl A. Schulman, PhD, MSW,1,6
Andrew J. Saxon, MD,3Asaad Awan, Pharm D,4Sonja Kapitan, Pharm D, MPH,4
Molly Carney, PhD,6Lyndia C. Brumback, PhD,1,5,7Dennis Donovan, PhD3,6
1Departments of Medicine,2Social Work,3Psychiatry and Behavioral Sciences,4Pharmacy, and5Biostatistics,6Alcohol and Drug Abuse
Institute, and7Center for AIDS Research,University of Washington, Seattle, WA, USA.
BACKGROUND: Methadone is effective treatment for opioid addiction,
but regulations restrict its use. Methadone medical maintenance treats
stabilized methadone patients in a medical setting, but only experi-
mental programs have been studied.
OBJECTIVE: To evaluate the implementation of the first methadone
medical maintenance program established outside a reseach setting.
DESIGN: One-year program evaluation.
SETTING: A public hospital and a community opioid treatment pro-
PARTICIPANTS: Methadone patients with 41 year of clinical stability.
Eleven generalist physicians and 4 hospital pharmacists.
INTERVENTIONS: Regulatory exemptions were requested. Physicians
and pharmacists were trained. Patients were transferred to the medical
setting and permitted 1-month supplies of methadone.
MEASUREMENTS: Patient eligibility and willingness to enroll, treat-
ment retention, urine toxicology results, change in addiction severity
and functional status, medical services provided, patient and physician
satisfaction, and physician attitudes toward methadone maintenance.
RESULTS: Regulatory exemptions were obtained after a 14-month
process, and the program was cited in federal policy as acceptable for
widespread implementation. Forty-nine of 684 patients (7.2%) met sta-
bility criteria, and 30 enrolled. Twenty-eight were retained for 1 year,
and 2 transferred to other programs. Two patients had opioid-positive
urine tests and were managed in the medical setting. Previously unmet
medical needs were addressed, and the Addiction Severity Index (ASI)
medical composite score improved over time (P=.02). Patient and phy-
sician satisfaction were high, and physician attitudes toward metha-
done maintenance treatment became more positive (P=.007).
CONCLUSIONS: Methadone medical maintenance is complex to ar-
range but feasible outside a research setting, and can result in good
KEY WORDS: methadone; heroin addiction; opioid-related disorders;
outcome and process assessment.
J GEN INTERN MED 2005; 20:344–349.
term methadone treatment reduces the individual and societal
costs of addiction,2,3and is more effective than methadone
treatment of limited duration.4–6Access to methadone treat-
pioid addiction is a chronic medical condition most ef-
fectively treated with medication and counseling.1Long-
ment in the United States is restricted to opioid treatment pro-
grams (OTPs), which are isolated from medical practice and
highly regulated.7This has led to inadequate funding, incon-
sistent access to care, large treatment programs that face com-
munity opposition to expansion, and a medical system that
treats the complications of addiction rather than the primary
Treatment of methadone maintenance patients by physi-
cians outside the existing OTP system has been attempted us-
ing a model known as methadone medical maintenance.9,10
Successful long-term methadone maintenance patients trans-
fer from traditional programs to a medical setting and are al-
lowed fewer treatment visits and more take-home medication.
The medical setting can destigmatize treatment, reduce con-
tacts with unstable patients, and facilitate treatment of ne-
glected medical problems.11Previous long-term observational
studies of methadone medical maintenance documented good
treatment retention and few safety problems.12,13Short-term
randomized trials comparing methadone medical maintenance
with regular clinic-based methadone treatment have demon-
strated similar addiction-related outcomes and improved pa-
tient satisfaction.14,15These results are based on experimental
programs authorized through the Investigational New Drug
(IND) process of the U.S. Food and Drug Administration
Our goal was to integrate methadone medical mainte-
nance into the continuum of care for opioid dependence by
seeking nonexperimental regulatory approval for a program
based in a general internal medicine clinic. Our program eval-
uation sought to determine the proportion of patients eligible
and willing to enter methadone medical maintenance. We also
tested whether these patients would remain stable, as meas-
ured by their retention in treatment, urine toxicology results,
and change in addiction severity and functional status over
time. Other measures included the utilization of primary care
medical services, patient and physician satisfaction, and
change in physician attitudes toward methadone treatment
after training and methadone medical maintenance practice.
We sought to develop a methadone medical maintenance pro-
gram that could be approved by all regulatory stakeholders
outside the experimental (IND) process. This required a col-
laborative process of policy and clinical protocol development
involving federal, state, and local regulatory agencies as well as
clinical participants from Harborview Medical Center (HMC)—
an urban public teaching hospital—and Evergreen Treatment
Services (ETS)—a nonprofit community OTP. We requested
Accepted for publication October 22, 2004
None of the authors has any conflicts of interest related to this man-
uscript.An earlier version of this work was presented at the Society of
General Internal Medicine annual meeting, Atlanta, GA, May 1, 2002.
Address correspondence and requests for reprints to Dr. Merrill: Har-
borview Medical Center, 325 Ninth Avenue, Box 359780, Seattle, WA
98104 (e-mail: firstname.lastname@example.org).
federal and state exemptions from opioid addiction treatment
regulations to initiate an HMC methadone medical mainte-
nance program affiliated with ETS. Exemptions included ex-
tended take-home dose privileges, dispensing of solid-form
methadone in multidose containers, decreased time in treat-
ment before eligibility for maximum take-home doses, and the
ability of HMC to order methadone directly. Protocols for phar-
macist assessment and dispensing of methadone were sub-
mitted to the Washington State Board of Pharmacy.
Financing for methadone services at HMC was provided
by patients’ existing payment sources. ETS received approxi-
mately one third of patient fees for maintaining space for
transfers and for providing counseling, billing, and program
licensing services. HMC received the remainder of patients’
methadone treatment fees, with two thirds of the HMC share
funding pharmacy services and one third funding medical
clinic services. In addition, HMC received reimbursement for
primary care services through patients’ medical insurance or
HMC’s low-income program for uninsured patients.
All methadone maintenance patients at ETS were screened.
Eligible patients picked up methadone no more than 3 times
weekly and fulfilled the following requirements: reliable at-
tendance, monthly urinalysis negative for illicit drugs for 12
months, no clinical or breathalyzer evidence of current alcohol
abuse or dependence, no outstanding legal issues or unpaid
program fees, and no untreated major psychiatric illness doc-
umented by ETS staff. ETS clinical staff discussed qualifying
patients to evaluate evidence of their clinical stability, includ-
ing social support, employment, and education. Ten of the
most clinically stable patients were transferred in January
2000 so that program logistics could be tested. Twenty addi-
tional patients transferred 2 to 6 months later.
All 11 attending physicians who worked more than 1 ses-
sion per week in the HMC adult medicine clinic agreed to par-
ticipate. The 4 participating pharmacists were from the HMC
pharmacy, which serves patients who receive care from the
HMC inpatient services and outpatient clinics. No physician or
pharmacist had previous addiction medicine or methadone
maintenance training or experience.
The initial provider training consisted of two 3-hour group
sessions. The first included an interview with an eligible pa-
tient and a discussion of addiction and methadone treatment,
in particular, clinical monitoring, dealing with instability, dose
adjustment, and program logistics (especially record keeping
and confidentiality). The second session involved a visit to ETS
for review of methadone maintenance practices and discussion
with staff. Ongoing clinical support included distribution of
literature and clinical consultation as requested. Providers
discussed cases and program logistics at 2 additional evening
meetings during the first year.
Patients transferred to HMC with once or twice weekly
methadone pick-up and became eligible for once-per-month
take-home status within 3 to 6 months. Patients picking up 3
times per week at ETS began twice weekly pick-up for 2
months before transfer. Dispensing visits occurred in the med-
ical clinic before usual business hours; pharmacists assessed
patient stability and primary care issues, observed ingestion of
a dose, and dispensed 10 mg methadone tablets in multidose
containers. Pharmacists also supervised monthly urine toxi-
cology testing, observing patients entering and leaving bath-
room facilities and temperature testing each sample. To limit
methadone diversion, patients were required to attend random
medication ‘‘call-backs,’’ returning within 24 hours for verifi-
cation of appropriate methadone use and for unscheduled
urine testing. Concerns regarding clinical instability triggered
collaborative assessment by physicians, pharmacists, coun-
selors, and clinical support staff to determine the need for ad-
ditional monitoring and treatment. Physician visits were
initially scheduled monthly; frequency was later adjusted
based on clinical need. All patients were offered optional pri-
mary care at HMC and drug counseling at ETS. Physicians and
pharmacists documented methadone visits in a separate
methadone chart, and physicians documented nonmetha-
done-related medical care in the HMC medical record.
Program Evaluation Methods
Treatment status and urinalysis results were assessed
through review of HMC methadone charts. Trained research
staff not involved in clinical care interviewed patients at base-
line, 6 months, and 12 months using the Addiction Severity
Index (ASI), 5th Edition,16and the Medical Outcomes Study
Short-Form 36 (SF-36).17Patient satisfaction was measured
using standard questionnaires modified for this study18and
semistructured questions eliciting the program’s effect on their
lives. Tobacco use and cessation efforts, and hepatitis testing
and treatment, were assessed with structured questions. A
physician (JOM) reviewed each HMC medical record to assess
medical diagnoses and treatments received.
Prior to training, physicians were surveyed regarding their
perceived knowledge of methadone maintenance and their in-
terest in providing methadone treatment. At 6 and 12 months,
physician satisfaction was measured using standard question-
naires modified for this study.18Prior to training and again
after 6 months of practice, physician attitudes toward metha-
done maintenance treatment were measured using standard-
ized questions developed originally for the evaluation of
methadone clinic staff attitudes.19–21Finally, semistructured
interviews were conducted with physicians to evaluate their
clinical support needs and to identify strengths and weakness-
es of the program.
The University of Washington Human Subjects Commit-
tee approved all study procedures, including written informed
consent from patients and physicians.
Baseline characteristics, treatment retention, and urine drug
toxicology are reported descriptively. To determine whether
ASI and SF-36 scores changed over time, the scores at base-
line, 6 months, and 12 months were analyzed using a random-
effects model. Specifically, we fit a linear regression model that
included random participant-to-participant variability in the
slope and intercept; the model accounts for correlation among
repeated measures from a participant.
Patient and physician satisfaction data are reported de-
scriptively, and data from semistructured interviews are sum-
marized based on qualitative analysis of responses. Change in
Merrill et al., Methadone Medical Maintenance in Primary Care
physician responses to questions concerning their attitudes
toward methadone treatment was assessed for each individual
question and for a summary score using the Wilcoxon signed
The policy process required sequential regulatory approval,
first from King County, then from the Washington State Divi-
sion of Alcohol and Substance Abuse. After state approval, the
FDA accepted program exemptions contingent upon approval
by the Drug Enforcement Administration (DEA). The DEA
process required review of program procedures at the nation-
al and regional levels, and inspection of the HMC site. The
approval process began in September 1998 and ended in
December 1999 with the granting of a DEA Narcotic Treat-
ment Program license.Soon
were approved by the Washington State Board of Pharmacy.
In March 2000, the FDA and the Center for Substance
Abuse Treatment (CSAT) announced the availability of meth-
adone medical maintenance exemptions, citing our program
as a model.22
Eligibility and Recruitment
Figure 1 outlines the screening process for the 684 ETS pa-
tients. Of the 109 patients with take-home privileges, 49 met
our inclusion criteria and 30 agreed to enroll. If patients with 6
rather than 12 months of stability had been eligible, 3 addi-
tional patients would have qualified (data not shown). One pa-
tient who did not qualify due to outstanding fees at ETS was
mistakenly permitted to enter the program, was soon found to
be clinically unstable, and was transferred back to ETS.
Addiction Treatment Outcomes
Baseline patient characteristics are presented in Table 1. Al-
though our eligibility criteria permitted entry of patients with
only 1 year of clinical stability, most exhibited long-term treat-
ment. Twenty-eight of 30 patients (93%) remained at HMC over
1 year. One transferred to a new ETS methadone program near
the patient’s home and a second moved from Washington State,
transferring to another methadone maintenance program.
During the first year, 28 of 30 patients (93.3%) had all
negative urinalysis results (445 of 449 total tests, 99.1%). Pa-
tients with positive urinalysis or other signs of possible insta-
bility (e.g., job stress, mental health issues) were managed
with increased frequency of physician and pharmacist visits,
and counseling at ETS. Overall, 19 patients had no ETS visits,
five had 1 to 5 visits, three had 6 to 10 visits, and three had
over 10 visits.
Random call backs (n=33) involved all patients between
months 4 and 12, and all call backs verified accurate metha-
done adherence. All associated unscheduled urinalysis tests
(7.3% of all tests) were negative for drugs of abuse and positive
The mean ASI composite scores and SF-36 scale scores
are presented in Table 2. ASI composite scores were generally
low at baseline. With the exception of the ASI medical com-
posite score, the slopes of ASI and SF-36 scores were not sig-
nificantly different from zero, suggesting that the scores did
not change over time. The ASI medical composite score showed
some improvement (slope=?.014/month; P=.02, unadjusted
for multiple comparisons).
Provision of Primary Medical Care
Of the 28 patients who remained at HMC for the first year, 26
received primary care at HMC, and 2 chose only opioid de-
pendence treatment. Visits to pharmacists (mean 26 visits,
range 17 to 64) and physicians (mean 11 visits, range 5 to 22)
allowed frequent opportunities to address primary care med-
Hepatitis C Virus. By the end of the first year, 20 of 28 patients
(71%) were identified as having been exposed to hepatitis C
virus (HCV), including 5 whose HCV status was newly clarified
at HMC. Nine patients were referred for further hepatitis eval-
uation during the first year, 7 were seen by a hepatologist, and
1 completed HCV treatment.
FIGURE1. Eligibility and recruitment for
Table1. Characteristics of Methadone Medical Maintenance
Patients (N=30) Characteristic
Mean age, y (SD)
Males, n (%)
White, n (%)
Employed/student, n (%)
Married/partnered, n (%)
Education, mean years (SD)
Age first used opioids, mean (SD)
Age first methadone treatment, mean (SD)
Methadone admits, mean (SD)
Years on methadone, mean (SD)
Current treatment duration, mean years (SD)
Years on methadone, range
Years with take-home privileges, mean years (SD)
mg/day methadone, mean (SD)
mg/day methadone, range
Insurance status, n (%)
Other medical insurance
SD, standard deviation.
Merrill et al., Methadone Medical Maintenance in Primary Care
Tobacco Use. Seventeen patients (60.7%) were current smok-
ers at baseline; 14 received cessation counseling by their phy-
sicians, 8 were referred to a pharmacy-based tobacco
cessation program, and 4 received pharmacotherapy for to-
bacco cessation. Six patients reported quit attempts during
the first year, and 3 were not smoking at 12 months; 8 reported
smoking less at 12 months than at baseline.
Hypertension. Eleven patients (39%) received pharmacothera-
py for hypertension. Four were treated for the first time at
HMC, and 2 others changed previously established hyperten-
Psychiatric Disorders. Depression and/or anxiety disorders
were diagnosed and treated for the first time in 4 patients. Thir-
teen patients had previous psychiatric disorders, 6 of whom re-
ceived changes in their pharmacotherapy during the first year.
Twenty-six of 30 (86.7%) patients reported being very satisfied
with the treatment they received and 2 (6.7%) somewhat sat-
isfied; the 2 transferred patients were not assessed. In semi-
satisfaction with the reduced frequency of visits, the individu-
alized professional care they received from physicians and
pharmacists, the attention to neglected health problems, and
the freedom from stigma associated with traditional OTPs. Ap-
pointment scheduling was the most frequent complaint, as it
proved difficult to coordinate pharmacy and physician ap-
pointments consistently. All 28 patients preferred the medical
setting to a drug treatment setting, and all planned to stay in
All physicians were general internists and had, on average, 10
years clinical experience after residency. None initially con-
sidered their level of knowledge sufficient to administer meth-
adone, but all expressed interest in being trained to provide
methadone to stabilized patients.
Physicians reviewed each case with a clinical support pro-
vider at least 3 times during the year. Additional clinical sup-
port requests (multiple discussions for 5 patients, occasional
discussion for 6, and little or no discussion for 18) usually
concerned dose change assessment, acute medical or mental
health problems, or possible patient instability. When asked
after 1 year to cite areas where additional training would have
been helpful, physicians most frequently mentioned the man-
agement of mental health diagnoses in the setting of addiction
Of the 10 physicians who completed the first year, 6 were
completely satisfied with the educational value of the program,
and 4 somewhat satisfied. In assessing satisfaction with treat-
ing each patient, physicians were completely satisfied in 14 of
28 cases (50%), somewhat satisfied in 12 (43%), and neutral or
somewhat dissatisfied in 2 (7%). Physicians reported very good
to excellent rapport with 23 (82%) patients and fair to good
rapport with the rest. Comparing them to other patients in
their public hospital practices, physicians generally viewed the
methadone medical maintenance patients as equally or more
compliant, equally or less in need of emotional support, and
the same or lower on acuity of psychosocial stressors. Physi-
cians were gratified to witness how patients benefited from the
program, and all indicated willingness to care for additional
methadone medical maintenance patients.
Physicians expressed concern regarding federal confidenti-
alityrules requiring segregation of methadone-related documen-
tation from primary care records. In providing both methadone
and primary care, these physicians had toassesswhether symp-
toms represented addiction-related instability, methadone dos-
ing, or other medical or psychiatric disorders, and they found
segregated record keeping to be artificial and constraining.
Physician attitudes toward methadone treatment became
more positive after training and 6 months of methadone med-
ical maintenance practice (Table 3). Significant changes
suggesting more positive attitudes toward methadone mainte-
nance treatment were found for 3 of 5 questions and for a
summary score combining all questions. After 1 year, physi-
cians noted significant learning about addiction and change in
their views of patients with addiction problems.
Our program was the first to obtain regulatory exemptions for
methadone medical maintenance in a nonexperimental set-
ting. Critical features of this model include close affiliation
with a cooperative OTP, training and clinical support for gen-
eralist physicians and pharmacists, and integrated primary
care medical services. These features enabled regulatory ap-
proval and good clinical outcomes, although substantial effort
was required to obtain exemptions and develop office proce-
Table2. Mean Baseline and Follow-up Addiction Severity Index?
Composite Scores and SF-36wScale Scores for Medical Mainte-
nance Patients (N=28)
Baseline 6-Month 12-MonthSlope (SE)
?Addiction Severity Index (ASI) composite scores range from 0 to 1, with
higher scores indicating more severe problems.
wMedical Outcomes Study Short-Form 36 (SF-36) scores range from 0 to
100 with higher values indicating higher functional status.
zThe ASI Medical Composite score is derived from 3 questions: 1) How
many days have you experienced medical problems in the last 30 days?
2) How bothered or troubled have you been by these medical problems in
the past 30 days? and 3) How important to you now is treatment for
these medical problems?
SE, standard error; ASI, Addiction Severity Index; SF-36, Medical Out-
comes Study Short-Form 36.
Merrill et al., Methadone Medical Maintenance in Primary Care
dures and protocols. Our program applied to a minority of
methadone maintenance patients, but given the close to
200,000 patients receiving methadone treatment in the Unit-
ed States today, extending this model could enhance care for a
significant number of stable patients.
Patients remained stable after transferring to methadone
medical maintenance. Our addiction outcomes were compa-
rableto thoseof earlier successful
grams,9,14,15and in addition we found possible improvement
in patients’ medical status over time. Similar temporal impro-
vements were not found in previous office-based methadone
trials that used the same ASI medical status measure.18,23
These trials, however, provided no integrated primary care
services. While our observational design is limited, these re-
sults suggest that when methadone medical maintenance de-
livers multiple interventions for previously unaddressed
medical problems, important health gains result. The benefits
of medical care in conjunction with addiction treatment have
been documented in other settings24–27and add to the ration-
ale for integrating these systems of care.
Affiliation with an existing OTP was required for regula-
tory approval and guarantees continuity of care if patients re-
lapse and need more frequent methadone dispensing. ETS
fully supported providing these services to eligible patients.
Other programs might be concerned that the transfer of stable
patients could affect staff morale or put a significant strain on
revenues, as many programs receive comparable reimburse-
ment for the most stable patients and for new patients with
multiple problems. This could impede widespread implemen-
tation of methadone medical maintenance. However, patients
who can benefit from a lower intensity of care should not suffer
from such adverse payment mechanisms.
Our program is unique in providing methadone mainte-
nance treatment in the ‘‘real world’’ medical practices of gen-
eralist physicians with no previous addiction medicine
experience. Our brief initial training program and ongoing
clinical support and consultation parallels practice patterns
in other medical specialties. Physicians expressed satisfaction
with this approach, and although we studied a small number
of physicians, there was evidence of increasingly positive atti-
tudes toward methadone maintenance. Such attitudes have
been associated with improved patient treatment retention.28
Physicians perceived co-occurring mental health issues as a
challenging aspect of care for this population, making this a
potential target for additional training.
No previous U.S. methadone medical maintenance pro-
gram has incorporated clinical pharmacists into methadone
dispensing and assessment of patients. Regular pharmacist
contact with patients facilitated their major role in clinical care
coordination. Pharmacists have been involved in the expan-
sion of methadone treatment capacity in other countries,29
and could play a similar role in the United States.
Our small sample size did not allow for meaningful cost
estimates, though costs will influence widespread implementa-
tion of this model. Reduced addiction services utilization has
been documented in methadone medical maintenance due to
additional take-home methadone doses.14However, Washing-
ton State methadone maintenance reimbursement policy does
not allow a commensurate reduction in charges for patients in
methadone medical maintenance. Thus, the additional provi-
sion of primary medical care inconjunction withaddiction treat-
ment monitoring may have increased overall costs of care while
adding the benefits of medical services. Initial grant funding was
required to develop and evaluate this program but did not sup-
port clinical services, allowing the continuation of this program
as a self-funding, collaborative project of HMC and ETS.
The relatively infrequent monitoring of patients in meth-
adone medical maintenance may have missed some drug use,
as more frequent testing and hair analysis has detected more
use in a similar population.18However, unremitting dependent
use is likely to be detected by monthly tests and clinical ob-
servations, and the clinical significance of intermittent use in
this setting is not clear. Random call backs discovered no
additional drug use or major irregularities in methadone
adherence, and these have been continued for patients re-
maining in our program. This diversion control measure was
not overly burdensome and may encourage patient adherence
while providing verification of appropriate methadone use.
Methadone medical maintenance cannot substantially
address the urgent need to increase access to initial metha-
done treatment in the United States, particularly for those in
need of public funding. Other countries have successfully in-
Table3. Physician Attitudes Toward Methadone Maintenance Before and After Methadone Medical Maintenance Training and Practice
Question Baseline Meanw(SD) Post Training and
1) No limits should be set on the duration of methadone
2) Methadone should be gradually withdrawn once a
maintenance patient has ceased using illegal opiates.z
3) Abstinence from all opioids (including methadone) should be
the principal goal of methadone maintenance.z
4) Maintenance patients should be given enough methadone to
prevent the onset of withdrawal symptoms.
5) When a methadone maintenance patient becomes pregnant,
she should be withdrawn from methadone.z
4.1 (0.74)4.8 (0.42) .02
3.8 (0.63) 4.5 (0.97) .08
3.9 (0.99)4.7 (0.48) .01
4 (0.67)4.6 (0.70) .03
4 (0.82)4.5 (0.71) .06
19.8 (2.86) 23.1 (2.51).01
?P values were obtained from Wilcoxon signed rank test (two-tailed), which tests the null hypothesis that each change comes from a distribution that is
symmetric with a mean of zero.
wBased on a 5-point scale (strongly agree to strongly disagree) with higher scores indicating more positive attitudes toward methadone maintenance
zBefore calculating means, scores were reversed for questions 2, 3, and 5 so that a higher value indicated more positive attitudes toward methadone
SD, standard deviation.
Merrill et al., Methadone Medical Maintenance in Primary Care
creased access to methadone by allowing generalist physicians Download full-text
to initiate treatment, with outcomes comparable to clinic-
based practice.29–32In the United States, initial treatment
may be provided by trained and certified physicians using
buprenorphine, a new medication recently approved by the
FDA for treatment of opioid dependence.33The reduced regu-
latory burden that applies to buprenorphine compared with
methadone medical maintenance may make it more attractive
to physicians. However, access to buprenorphine or metha-
done will remain restricted unless funding levels for addiction
treatment are increased or parity between medical and addic-
tion treatment insurance is established.
Recent changes in federal regulations permit OTPs new
clinical flexibility.34Clinics may now give 1-month supplies of
take-home methadone to successful patients after 2 years in
treatment, addressing part of the rationale for methadone
medical maintenance. However, integrated methadone medi-
cal maintenance can provide the additional benefits of enhanc-
ing patient satisfaction with methadone treatment, reducing
patient contact with less stabilized patients, developing phy-
sician expertise in addictions, and improving the medical care
of patients in methadone treatment. The new regulations ex-
plicitly request exemption applications to create methadone
medical maintenance programs and thus expand access to
this care model for other stabilized methadone maintenance
While complex, it is feasible to obtain regulatory approval
and train generalist physicians and pharmacists to provide
methadone medical maintenance with good patient outcomes,
high levels of patient and provider satisfaction, and potential
improvement in physician attitudes toward methadone treat-
ment. While the complexity of regulatory policy and program
protocol development is substantial and may limit expansion
of this model of care, the precedent set by our program should
facilitate smoother regulatory approval for future programs.
This work was assisted by a grant from the Robert Wood John-
son Foundation Substance Abuse Policy Research Program
(RWJF grant 34895). We are grateful for the data manage-
ment and statistical support of Katie Weaver, for the comments
of Elizabeth Dickinson on earlier versions of the manuscript, and
for the participation of patients and providers.
1. Dole VP. Implications of methadone maintenance for theories of narcotic
addiction. JAMA. 1988;260:3025–9.
2. Effective medical treatment of opiate addiction. National Consensus De-
velopment Panel on Effective Medical Treatment of Opiate Addiction.
3. Barnett PG, Hui SS. The cost-effectiveness of methadone maintenance.
Mt Sinai J Med. 2000;67:365–74.
4. Ball J. The Effectiveness of Methadone Maintenance Treatment: Pa-
tients, Programs, Services, and Outcomes. New York, NY: Springer-Ver-
5. Sees KL, Delucchi KL, Masson C, et al. Methadone maintenance vs
180-day psychosocially enriched detoxification for treatment of opioid
dependence: a randomized controlled trial. JAMA. 2000;283:1303–10.
6. Gossop M, Marsden J, Stewart D, Treacy S. Outcomes after methadone
maintenance and methadone reduction treatments: two-year follow-up
results from the National Treatment Outcome Research Study. Drug Al-
cohol Depend. 2001;62:255–64.
7. Rettig RA, Yarmolinsky A, eds. Federal Regulation of Methadone Treat-
ment. Washington, DC: National Academy Press; 1995.
8. Merrill JO. Policy progress for physician treatment of opiate addiction. J
Gen Intern Med. 2002;17:361–8.
9. Novick DM, Pascarelli EF, Joseph H, et al. Methadone maintenance
patients in general medical practice. A preliminary report. JAMA.
10. Novick DM, Joseph H. Medical maintenance: the treatment of chronic
opiate dependence in general medical practice. J Subst Abuse Treat.
11. Novick DM, Richman BL, Friedman JM, et al. The medical status of
methadone maintenance patients in treatment for 11–18 years. Drug
Alcohol Depend. 1993;33:235–45.
12. Salsitz EA, Joseph H, Frank B, et al. Methadone medical maintenance
(MMM): treating chronic opioid dependence in private medical practice—
a summary report (1983–1998). Mt Sinai J Med. 2000;67:388–97.
13. Schwartz RP, Brooner RK, Montoya ID, Currens M, Hayes M. A 12-
year follow-up of a methadone medical maintenance program. Am J Ad-
14. King VL, Stoller KB, Hayes M, et al. A multicenter randomized evalu-
ation of methadone medical maintenance. Drug Alcohol Depend.
15. Senay EC, Barthwell A, Marks R, Bokos PJ. Medical maintenance: an
interim report. J Addict Dis. 1994;13:65–9.
16. McLellan AT, Kushner H, Metzger D, et al. The Fifth Edition of the Ad-
diction Severity Index. J Subst Abuse Treat. 1992;9:199–213.
17. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey
(SF-36). I. Conceptual framework and item selection. Med Care.
18. Fiellin DA, O’Connor PG, Chawarski M, Pakes JP, Pantalon MV,
Schottenfeld RS. Methadone maintenance in primary care: a randomi-
zed controlled trial. JAMA. 2001;286:1724–31.
19. Caplehorn JR, Irwig L, Saunders JB. Attitudes and beliefs of staff
20. Caplehorn JR, Hartel DM, Irwig L. Measuring and comparing the atti-
tudes and beliefs of staff working in New York methadone maintenance
clinics. Subst Use Misuse. 1997;32:399–413.
21. McNeely J, Drucker E, Hartel D, Tuchman E. Office-based methadone
prescribing: acceptance by inner-city practitioners in New York. J Urban
22. Lepay D, Clark HW. Federal Advisory on Methadone Medical Mainte-
nance Exemptions. Washington, DC: Department of Health and Human
23. Senay EC, Barthwell AG, Marks R, Bokos P, Gillman D, White R. Med-
ical maintenance: a pilot study. J Addict Dis. 1993;12:59–76.
24. Weisner C, Mertens J, Parthasarathy S, Moore C, Lu Y. Integrating
primary medical care with addiction treatment: a randomized controlled
trial. JAMA. 2001;286:1715–23.
25. Laine C, Hauck WW, Gourevitch MN, Rothman J, Cohen A, Turner
BJ. Regular outpatient medical and drug abuse care and subsequent
hospitalization of persons who use illicit drugs. JAMA. 2001;285:2355–
26. Willenbring ML, Olson DH. A randomized trial of integrated outpatient
treatment formedically illalcoholic
27. Friedmann PD, Zhang Z, Hendrickson J, Stein MD, Gerstein DR. Ef-
fect of primary medical care on addiction and medical severity in sub-
stance abuse treatment programs. J Gen Intern Med. 2003;18:1–8.
28. Caplehorn JR, Lumley TS, Irwig L. Staff attitudes and retention of pa-
tients in methadone maintenance programs. Drug Alcohol Depend.
29. Weinrich M, Stuart M. Provision of methadone treatment in primary
care medical practices: review of the Scottish experience and implica-
tions for US policy. JAMA. 2000;283:1343–8.
30. Hutchinson SJ, Taylor A, Gruer L, et al. One-year follow-up of opiate
injectors treated with oral methadone in a GP-centred programme. Ad-
31. Gossop M, Stewart D, Browne N, Marsden J. Methadone treatment for
opiatedependent patientsin general practice and specialistclinic settings:
outcomes at 2-year follow-up. J Subst Abuse Treat. 2003;24:313–21.
32. Brands J, Brands B, Marsh D. The expansion of methadone prescribing
in Ontario, 1996–1998. Addict Res. 2000;8:485–96.
33. Fiellin DA, O’Connor PG. Clinical practice. Office-based treatment of
opioid-dependent patients. N Engl J Med. 2002;347:817–23.
34. Opioid drugs in maintenance and detoxification treatment of opiate ad-
diction; Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services. Final rule. Fed Regist.
Merrill et al., Methadone Medical Maintenance in Primary Care