Office-Based Methadone Treatment for Opioid Use Disorder and Pharmacy Dispensing: A Scoping Review
Abstract
Objective:
Methods:
Results:
Conclusions:
Methods
Search Strategies
Study Selection
Results
Study and Description | Study Design and Number of Patients | Setting and Location | Intervention | Main Findings | Limitations |
---|---|---|---|---|---|
U.S.-based RCTs | |||||
Fiellin et al. (12) | RCT, N=46; SAMHSA and DEA exceptions | Office-based primary care setting; New Haven, Conn. | Comparison of methadone OTP in primary care with OTP in stabilized patients on methadone. A: primary care methadone dispensed in the office (N=22); B: OTP methadone opioid agonist therapy (N=24) | Similar rates of illicit drug use, functional status, and use of health, legal, or social services; primary care methadone maintenance more likely to be rated excellent by patients | Small sample |
King et al. (13); 12-month follow-up results for King et al. (14) | RCT, N=92; SAMHSA and DEA exceptions | Primary care, office-based specialty setting compared with OTP; Baltimore | A: Methadone in office-based setting with 27 take-homes (N=33); B: methadone in OTP with 27 take-homes (N=32); C: usual methadone in OTP (N=27) | Low rates of drug use or failed medication recall; treatment satisfaction high in all groups; methadone patients initiated more new employment and family and social activities than usual methadone | Small sample |
King et al. (14); same study as King et al. (13) with fewer study participants and 6 months of follow-up | N=73 | Same as above | Same as above | Six months of follow-up; overall, 1% of urine specimens were positive for illicit drugs; no evidence of methadone diversion; low rates of medication misuse | |
Senay et al. (15) | RCT, N=130; FDA IND approval | Office-based specialty setting; U.S. | A: Medical methadone in office-based setting (N=89); B: usual methadone in OTP (N=41); OTP dispensed methadone for both patient groups | Retention rate, 73% for medical methadone compared with 73% for usual methadone treatment in OTP at 1 year; addiction severity similar in both groups at 1 year; no difference in positive urine toxicology screens | Small sample; dated study |
Tuchman et al. (16); Tuchman et al. (17) | RCT, N=26; SAMHSA and DEA exceptions | Primary care setting; Santa Fe and Albuquerque, N.M., U.S. | A: Medical methadone in primary care setting (physician office, community pharmacy, and social work) (N=14; analyzed: N=13) compared with B: methadone in OTP (N=12; analyzed: N= 9) | At 12 months, retention was 100% compared with 89%; illicit opioid use was 23% compared with 78%; urine toxicology positive for cocaine was 23% compared with 44%; and urine toxicology positive for benzodiazepines was 8% compared with 44% | Small sample; women only; loss to follow-up; allowed participants to switch conditions following randomization |
Non-U.S. RCTs | |||||
Carrieri et al. (18) | RCT, N=221 | Primary care or specialty care setting in France; methadone dispensed at pharmacies for patients in primary care | A: Methadone induction in primary care (N=155); B: methadone induction in specialty care (N=66) | Methadone induction in primary care is feasible and acceptable to physicians and patients and similar to induction in specialized care for abstinence and retention | |
Lintzeris et al. (19) | RCT, N=139 | Primarily primary care setting (18 general practitioner practice sites and one office-based specialist clinic); Australia | A: Office-based buprenorphine (with pharmacy dispensing); (N=73); B: methadone clinic-based buprenorphine (N=66) | Heroin use; retention similar in both groups | Study focused on initiation of buprenorphine; methadone patients had to be taking <60 mg/day before buprenorphine was initiated |
U.S.-based observational studies | |||||
Fiellin et al. (30); qualitative analysis of Fiellin (12) | Clinical chart audit of the 22 patients who received office-based methadone and focus group with six participating physicians providing care in the 2001 RCT of office-based methadone | Evaluation of processes of care during office-based treatment of OUD with methadone | Lapses in care (urine drug monitoring, paperwork completion) and barriers (logistics of dispensing, receipt of urine toxicology results, difficulties arranging psychiatric services, communications with OTP, and nonadherence to medication) identified; physicians recommended dispensing in pharmacies rather than their office | Small sample; no comparison group | |
Drucker et al. (20); includes pharmacy dispensing | Observational study, uncontrolled retrospective treatment series, N=10; used FDA IND approval from Harris et al. (21) | Office-based specialty setting; Lancaster, Pa. | Evaluation of methadone agonist therapy in an office-based specialty setting with pharmacy dispensing in stabilized patients | Ten patients enrolled in office-based methadone and able to receive methadone in a community pharmacy; 1% (N=2/216) of urine drug tests positive for illicit substances; patients reported increased satisfaction | Small sample; no comparison group |
Harris et al. (21); includes pharmacy dispensing | Observational study, uncontrolled retrospective treatment series, N=127; FDA IND approval | Office-based specialty setting; New York | Outcomes of office-based medical methadone program (N=127) and comparison with OTP patients (N=3,342); medical methadone patients were employed (or unemployed due to disability or retirement), had no evidence of opioid, cocaine, or benzodiazepine abuse in the past 3 years, and had psychiatric stability; methadone dispensed from a central pharmacy | Patients in office-based methadone medical settings were older than traditional OTP patients (mean age, 52 years compared with 44 years), and more likely to be male (72% compared with 59%) and Caucasian (50% compared with 17%); proportion with urine sample positive for nonprescribed opioids was 0.8% and 0.4% for cocaine | Small sample; office-based group |
Merrill et al. (22); includes pharmacy dispensing | Observational study uncontrolled retrospective treatment series, N=30; SAMHSA and DEA exceptions | Primary care setting; Seattle | Evaluation of medical methadone therapy in primary care settings in stabilized patients; the hospital pharmacy dispensed the methadone | Retention at 1 year was 93%; positive urine drug screen was 6.7%; improvement in Addiction Severity Index score over time and patient satisfaction were high | Small sample; no comparison group |
Des Jarlais et al. (23); initial patients for Novick et al. series (24–26) | Observational study, uncontrolled retrospective treatment series, N=28 (first 28 patients) at 12-month follow-up; FDA IND approval | Office-based specialty setting; New York (providers with experience in drug abuse treatment) | Evaluation of methadone agonist therapy in an office-based specialty setting in stabilized patients | At 12 months, 89% (N=25/28) retention; one patient successfully detoxified, one required short-acting opioid for surgery and back pain, and one requested transfer back to the methadone clinic; patients reported more mobility and privacy, less anxiety about treatment, improved employment situations, improved self-esteem, and perceived reduction in stigma | Small sample; no comparison group |
Novick et al. (25) | Patients transferred from Rockefeller University to Beth Israel OTP, N=40 (first 40 participants) | Same as above | Methadone was from the hospital pharmacy and dispensed in the primary care office | 12–55 months of follow-up; 83% remained on medical methadone with a 94% annual retention rate; five returned to OTP because of cocaine use | Same as above |
Novick et al. (24) | Follow-up data for 3.5–9.25 years (or status at discharge), N=100 | Same as above | Same as above | Retention was 98%, 95%, and 85% at 1, 2, and 3 years, respectively; cumulative proportional survival in treatment was 0.74 at 5 years and 0.56 at 9 years; after 42 to 111 months, 72 patients remained in good standing, 15 had unfavorable discharge, seven voluntarily withdrew in good standing, four died, one transferred to a chronic care facility, and one voluntarily left the program | Same as above |
Salsitz et al. (26); report on 15 years | N=158 | Same as above | Same as above | 132 patients (84%) were program adherent and treatable within office-based settings; retention was 99%, 96%, and 89% at 1, 2, and 3 years, respectively; 13% died (no overdoses); 16% returned to OTP | Same as above |
Schwartz et al. (27) | Observational study, uncontrolled retrospective treatment series, N=21; FDA IND approval | Primary care setting; Baltimore | Evaluation of medical methadone therapy in primary care settings in stabilized patients; methadone was dispensed in the primary care office | After 12 years, 29% of patients dropped out, and 0.5% urine samples were positive for drugs; no methadone overdose or diversion; participants reported significant improvement in quality of life | Small sample; no comparison group |
Non-U.S. observational studies | |||||
Gossop et al. (28) | Observational study; prospective sample, N=240 | Primary care setting compared with drug clinic setting; U.K. | A: Methadone in general practitioner clinics with dispensing from the office or community pharmacy (N=79) compared with B: methadone in drug clinics with dispensing in the clinic or community pharmacy (N=161) | Reductions in illicit drug use, injecting, sharing injection equipment, psychological and physical health problems, and crime in both groups at 1 and 2 years; patients in general practice settings had less frequent benzodiazepine and stimulant use and fewer psychological health problems | |
Mullen et al. (29) | Retrospective randomly selected sample of methadone admissions in 1999, 2001, and 2003, N=1,269 | Central methadone treatment list; Ireland | Random sample of new patients receiving methadone treatment from specialty clinics, community medical clinics, and trained physicians in 1999, 2001, and 2003 to assess variables associated with retention in care | Participants were primarily men (69%), with a mean age of 26 years (75% under age 30); 95% received daily dosing with a mean dose of 58 mg/day; doses in primary care were lower (53 mg/day) compared with specialty clinics (60 mg/day); 61% remained in care for more than 1 year; primary cause of leaving in less than 1 year was “treatment failure”; logistic regression suggested retention at 12 months was associated with gender (women were more likely to remain in care); patients in specialty clinics were two times more likely to leave care than those in physician care; patients receiving a daily dose <60 mg/day were three times more likely to leave care than patients receiving doses >60 mg/day | |
U.S. and non-U.S. pharmacy studies | |||||
Bowden et al. (31) | Descriptive, uncontrolled retrospective treatment series of OTP patients with pharmacy dispensing, N=96; began prior to FDA regulations | Community pharmacies; San Antonio, Tex. | Description of community pharmacy dispensing of methadone for OUD (N=96); data collection began prior to the 1973 FDA regulations that restrict dispensing to OTPs | Retention was 70% at 1 year; 3% were voluntarily abstinent, 10% using heroin, 9% in jail, prison, or the hospital, 1% dead, 63% employed, and 15% partially employed; proportion arrested in the prior year decreased from 66% to 58% | Small sample; no comparison group |
Joudrey et al. (4) | Descriptive, cross-sectional analysis of travel time to OTPs and pharmacies, N=7,918; census tracts in five states | OTPs compared with community pharmacies; U.S. | Comparison of drive time to OTP versus community pharmacies | Median drive time longer to OTP than chain pharmacies (19.6 compared with 4.4 minutes); difference greater in increasingly rural census tracts (11.5–35.2 minutes) | |
Kleinman et al. (5) | Descriptive, cross-sectional analysis of travel time to OTPs and pharmacies, N=72,443; U.S. census tracts | OTPs compared with community pharmacies; U.S. | Comparison of drive time to OTPs (N=1,682) versus community pharmacies (N=69,475) | Mean population-weighted driving time was 20.4 minutes to OTPs and 4.5 minutes to pharmacies; drive times increased in metropolitan and noncore counties | |
Keen et al. (32) | Descriptive, ecological analysis of methadone deaths before and after pharmacy dispensing of methadone as an opioid agonist therapy, N=400 | Primary care setting; U.K. | Evaluation of trends in methadone-associated mortality following implementation of widespread methadone prescribing in primary care; dispensing in community pharmacy | Decrease in methadone deaths in the city following implementation of widespread methadone prescribing in primary care, despite increase in methadone prescribing |
U.S. Clinical Trials
Non-U.S. Randomized Trials
U.S. Observational Studies
Non-U.S. Observational Analyses
Pharmacy Dispensing
Discussion
Limitations
Practice and Policy Implications
Future Research
Conclusions
Supplementary Material
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