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
- View/Download
- 573.57 KB
References
Information & Authors
Information
Published In
History
Keywords
Authors
Competing Interests
Funding Information
Metrics & Citations
Metrics
Citations
Export Citations
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.
For more information or tips please see 'Downloading to a citation manager' in the Help menu.
View Options
View options
PDF/EPUB
View PDF/EPUBLogin options
Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.
Personal login Institutional Login Open Athens loginNot a subscriber?
PsychiatryOnline subscription options offer access to the DSM-5-TR® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.
Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).