SummaryThe Baltimore Interim Methadone Maintenance program provided interim care (in the form of daily methadone with emergency counseling only) to heroin addicts awaiting placement for comprehensive methadone treatment programs. Operating within U.S. Federal regulations, the program increased service capacity and offered immediate access to the treatment system. Program participants were found to be significantly less likely to test positive for drug use or to report using heroin in the past 30 days. They were also more likely to enter into a comprehensive methadone treatment program and less likely to be arrested at 6 months post-enrollment than were those in a control group. Compared with nonparticipants, program participants were less likely to test positive for drug use or to report using heroin in the past 30 days, were more likely to enter into a comprehensive methadone treatment program, and were less likely to be arrested. Other evidence suggests successful transfer to standard treatment programs and a decrease in opioid-positive tests, as well as an increase in process efficiency by expediting the intake process up to 2 weeks, compared with those on the waiting list.Strong: The evidence consists of two randomized, controlled trials evaluating the number of days of heroin use in the past 30 days, drug-test results, enrollment in a comprehensive methadone treatment program, and the frequency and severity of arrest charges; a naturalistic study evaluating transfer to a standard program and change in opioid-positive tests; and anecdotal evidence regarding program efficiency.
Developing OrganizationsBaltimore Substance Abuse Systems, Inc.; Friends Research Institute, Inc.
As of October 2013 Baltimore Substance Abuse Systems, Inc., merged with Baltimore Mental Health Systems to form Baltimore Behavioral Health System. Baltimore, MD
Date First Implemented2005
Vulnerable Populations > Substance abusers
Problem AddressedEffective drug treatment must be readily accessible,1 but heroin addicts in several U.S. cities are typically required to wait to enter a comprehensive methadone treatment program. Although interim methadone maintenance can bridge this treatment gap, regulatory barriers have deterred the implementation of such programs for more than a decade.
- Increased risk due to lack of immediate access to treatment: Treatment-seeking heroin addicts in several U.S. cities, including Baltimore, MD, until the recent expansion of its Medicaid program, are routinely placed on waiting lists for methadone treatment programs. When treatment is delayed, heroin addicts are exposed to the harms associated with continued heroin use, including HIV/AIDS and death from an overdose.2,3
- Reduced motivation or ability to participate: If treatment is not immediately available when heroin addicts are motivated, they may lose interest or be unreachable when an opening in a methadone treatment program becomes available.4
- Interim methadone maintenance as a potential temporary solution, but difficult to implement: Interim methadone maintenance programs can provide interim care to heroin addicts awaiting placement in a comprehensive methadone treatment program. However, Federal regulations passed in 1993 place stringent restrictions on the delivery of interim methadone maintenance services,5 which has precluded the implementation of such programs for more than a decade.2,3 These regulations include complicated approval processes as well as requirements that interim methadone maintenance clinics be operated by nonprofit organizations, operate 365 days a year so that all dosing can be observed, provide services for no more than 120 days before admitting participants to a full-service methadone treatment program, and offer emergency counseling.
Description of the Innovative ActivityDuring its operation, Baltimore Interim Methadone Maintenance program provided interim care (in the form of daily methadone with emergency counseling) to heroin addicts who were on waiting lists for comprehensive methadone treatment programs. Operating within U.S. Federal regulations, Baltimore's program increased service capacity and offered immediate access to the treatment system. The program ceased operation in June 2011 when an expansion of the state Medicaid program to cover methadone treatment eliminated most waiting lists in Baltimore. Key elements of the program included the following:
- Clinic locations: The interim methadone maintenance program was implemented by four organizations that also operate comprehensive methadone treatment programs. Each site had the capacity to serve 50 interim methadone maintenance patients. As required by Federal regulations, the sites were open 365 days a year (including all holidays): 7 a.m. to 7 p.m. Monday through Friday and 2 to 3 hours in the morning on Saturdays and Sundays, thus allowing dosing to be observed. As required by Federal regulations, patients were admitted to the affiliated methadone treatment program within 120 days.
- Treatment process and services: The program screened those interested in treatment and provided interim care to those who met the criteria for participation. Key elements of the service process are described below:
- Referral process: Heroin addicts were able to request methadone treatment by contacting Baltimore City's substance abuse authority or 1 of the city's 14 full-service methadone treatment programs directly. If treatment slots were available and a program was not able to accommodate the request for methadone, the person seeking methadone was placed on a waiting list and referred to one of the four full-service methadone treatment programs that offer interim methadone maintenance services.
- Screening and intake: Individuals requesting interim methadone maintenance services attended an intake appointment, usually within a few days of their request for treatment. At this first appointment, a physician physically examined the individual and collected a medical history. The prospective enrollee was required to provide a urine sample for drug testing and a blood sample to test for sexually transmitted diseases. In addition, an addictions counselor interviewed the individual and completed a psychosocial assessment. The results of the physical examination, including medical history, intake interview, and psychosocial assessment, determined whether or not the individual seeking treatment met the criteria6 for interim methadone maintenance services.7
- Daily methadone: A nurse provided methadone to interim methadone maintenance enrollees 7 days a week, 365 days a year at minimal cost to patients. Dosing began at a low dose, which was increased by 5 mg per day to a target of 80 mg, and was observed by the dispensing nurse, with no take-home doses allowed. Patients were able to receive these services for up to 120 days, at which time they had to be admitted to a comprehensive methadone treatment program.
- Emergency counseling: As required by Federal regulations, counseling was available to program participants on an emergency basis.
- Random drug testing: Patients were tested on admission and at least twice during interim methadone treatment.
Context of the InnovationBaltimore Substance Abuse Systems (now part of Baltimore Behavioral Health System), a quasi-public, nonprofit corporation, is the Baltimore City Health Department's designated substance abuse authority, responsible for providing oversight and managing grant funding for all drug and alcohol services in the city. The original randomized trial was conducted at the Institutes for Behavior Resources' REACH (Recovery Enhanced by Access to Comprehensive Healthcare) Mobile Health Services, a nonprofit organization. Interim methadone was then expanded to six opioid treatment programs in Baltimore with support from the Center for Substance Abuse Treatment and oversight from Baltimore Substance Abuse Systems, including Glass Daybreak Rehabilitation Program; Man Alive; the Institutes for Behavior Resources' REACH Mobile Health Services program, a state-certified, opioid-agonist treatment program that provides outpatient substance abuse treatment, detoxification, and methadone maintenance services to Baltimore residents; Sinai Hospital of Baltimore, a nonprofit teaching hospital providing outpatient substance abuse treatment, detoxification, methadone maintenance, and methadone detoxification services; the University of Maryland Methadone Treatment Program, an outpatient treatment facility providing methadone maintenance and detoxification; and the Johns Hopkins University Behavioral Biology Research Unit, an internationally recognized center for research on psychoactive drugs. The second randomized trial was conducted at the University of Maryland and REACH programs.
The idea to establish an interim methadone maintenance program in Baltimore originated with Dr. Jerry Jaffe's pioneering work in Chicago in the early 1970s, along with the work initiated by Drs. Don Des Jarlais and Vincent Dole in New York City during the AIDS epidemic in the late 1980s. Together with Dr. Robert P. Schwartz and other researchers at the Friends Research Institute, Dr. Jaffe recognized the potential to reduce waiting time for treatment-seeking heroin addicts in Baltimore. The group then embarked on an effort to develop a program that would comply with Federal regulatory requirements that had deterred many others from implementing interim methadone maintenance programs since the regulations were passed in 1993.
ResultsResults from a randomized, controlled trial found that interim methadone maintenance participants were significantly less likely to test positive for drug use or to report using heroin in the past 30 days and were significantly more likely to enter into a comprehensive methadone treatment program and remain there than were those in a control group who remained on a waiting list.2,3 In 2009, an additional analysis from that trial found that program participants were less likely to be arrested at 6 months post-enrollment than were members of a control group. In 2011, a second randomized, controlled trial found no significant difference in treatment outcomes between methadone-alone treatment and methadone-with-routine-counseling treatment in terms of retention in treatment, heroin and cocaine use, and HIV-risk behavior. Information provided in January 2013 indicates that a naturalistic study of 1,000 patients treated in 6 methadone programs in Baltimore demonstrated successful transfer to standard treatment and a decrease in opioid-positive tests. Anecdotal evidence indicated that interim methadone maintenance increased process efficiency by expediting the intake process up to 2 weeks, compared with those on the waiting list.
Strong: The evidence consists of two randomized, controlled trials evaluating the number of days of heroin use in the past 30 days, drug-test results, enrollment in a comprehensive methadone treatment program, and the frequency and severity of arrest charges; a naturalistic study evaluating transfer to a standard program and change in opioid-positive tests; and anecdotal evidence regarding program efficiency.
- Less heroin use: Interim methadone maintenance participants reported fewer mean days of heroin use in the past 30 days (4.2 days of use at first followup; 5.7 days at second followup) than did the control group (26.4 days at first followup; 17.7 days at second followup). Participants also were less likely to have a positive drug test (56.6 percent at first followup; 48.1 percent at second followup) than were control group participants (79.2 percent at first followup; 73.3 percent at second followup).
- More likely to seek comprehensive treatment: Participants were more likely to report having entered a comprehensive methadone treatment program (75.9 percent at first followup; 78.4 percent at second followup) than were control group participants (20.8 percent at first followup; 32.5 percent at second followup).
- Fewer arrests: According to the 2009 study, interim methadone maintenance participants showed a significant reduction in number of arrests at 6 months post-enrollment, compared with a control group who remained on a waiting list.8
- Better outcomes associated with interim methadone usage: A second randomized, controlled trial conducted in 2 methadone treatment programs with 230 newly-admitted patients found no significant differences between methadone alone and methadone with routine counseling in terms of days in treatment, self-reported heroin or cocaine use, heroin- or cocaine-positive urine drug tests, or HIV risk behavior. Information provided in January 2013 indicates that at 4-month followup, interim methadone participants had significantly lower self-reported days of criminal activity, money spent on drugs, and illegal income. At 12-month followup, there were no differences between groups for retention in treatment, opioid- or cocaine-positive urine tests, number of arrests, or HIV risk behavior. These findings further suggest that when standard methadone treatment is unavailable, interim methadone should be more widely used and less restricted.9,10,11
- Successful transfer to standard treatment: Information provided in January 2013 indicates that a naturalistic study of 1,000 patients treated in 6 methadone programs in Baltimore demonstrated that 76.2 percent were successfully transferred to standard treatment.12
- Decrease in opioid-positive tests: Information provided in January 2013 indicates that the naturalistic study noted that opioid-positive tests decreased from 89.6 percent at baseline to 38.4 percent after interim methadone treatment at the time of transfer to standard treatment.12
- Expedited intake process: By capitalizing on participants' motivation and offering immediate access to the treatment system, interim methadone maintenance increased process efficiency. Anecdotal evidence indicated that because participants had already completed the intake process, they were quickly transferred into a comprehensive methadone treatment program once a slot became available. In contrast, those on the waiting list often experienced additional delays of up to 2 weeks as staff commonly encountered difficulties locating individuals from the waiting list and setting up intake appointments.
Planning and Development ProcessKey steps in the planning and development process include the following:
- Forging partnerships: Program founders involved partners in the development process, including holding discussions on how to overcome program implementation challenges, such as complying with Federal regulations.
- Complying with regulatory requirements and seeking approval: To overcome stringent regulatory requirements, Baltimore Substance Abuse Systems (now part of Baltimore Behavioral Health System) worked with its two nonprofit partners to establish the interim methadone maintenance program at two locations. Because these partners ran 2 of the 14 full-service methadone treatment programs in the city, the proposed program was more easily able to meet the 1993 Federal requirements related to dosing oversight, counseling, and transfer to a methadone treatment program within 120 days. Baltimore Substance Abuse Systems completed all necessary paperwork to secure approval from city, State, and Federal regulators.
- Conducting the initial randomized, controlled trial and a subsequent demonstration project: Program developers partnered with a nonprofit, community-based, full-service methadone treatment program to conduct a randomized, controlled trial to test the effectiveness of the program. Positive findings from this trial led to the recruitment of 5 additional sites in Baltimore for participation in a demonstration project that treated more than 1,000 patients.12 Although interim methadone maintenance services were temporarily suspended at the conclusion of the demonstration project for lack of funding, two of the nonprofit organizations involved in the demonstration project agreed to partner with Baltimore Substance Abuse Systems to continue the program until 2010 when, because of an expansion of the state Medicaid program to cover methadone treatment, waiting lists were no longer the norm in Baltimore.
Resources Used and Skills Needed
- Staffing: Staff from the comprehensive methadone treatment programs rotated to provide coverage for the interim methadone maintenance program at the four sites. Positions included an intake counselor (who worked 1 to 2 hours a week) to conduct the initial interview, a physician (less than 1 hour a week) to conduct the physical examination and adjust dosages as appropriate, a counselor (less than 1 hour a week) who was available for emergency counseling, and a nurse (1 to 2 hours a week) to administer methadone. The mobile medical unit site also employed a full-time driver/security guard.
- Costs: Baltimore Substance Abuse Systems reimbursed providers approximately $30 per week per interim methadone maintenance patient. Fees for participants were based on a sliding-fee scale and typically ranged from $2 to $5 per week. The annual operating budget for the program was $140,000.
Funding SourcesCenter for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration; National Institute on Drug Abuse; Maryland Alcohol & Drug Abuse Administration
The program provided interim methadone through two National Institute on Drug Abuse–funded, randomized clinical trials, a Center for Substance Abuse Treatment–funded treatment capacity expansion grant, and subsequently with local funding (updated January 2013).
Getting Started with This Innovation
- Identify potential partners: Appropriate partnerships are essential for the initiation of an interim methadone maintenance program. Potential adopters will need to identify nonprofit opioid treatment programs that operate 7 days a week (including holidays), currently operate a comprehensive methadone treatment program, and are willing and able to transfer interim methadone maintenance patients into their comprehensive methadone treatment program within the required 120 days.
- Understand the approval process: Establishing an interim methadone maintenance program is a complicated process that requires approval at multiple levels. Therefore, it is critical to understand all local, State, and Federal regulations that govern the establishment of such programs and to accurately complete all necessary paperwork and submit it to the appropriate agencies.
- Secure buy-in from key stakeholders: Securing buy-in from local and State substance abuse agencies can help facilitate the approval process; these agencies can also assist with the negotiation of approval at the Federal level. It is important to gain the support of clinic staff who will be operating the program because the additional services they will be providing may create additional burdens for them.
- Secure funding: A funding source, such as local or State grants, could help to pay for daily operation of the program.
Sustaining This Innovation
- Market program to maintain buy-in from key stakeholders: Continually emphasize program benefits to the public health and safety and results (e.g., reduced risk to drug-addicted individuals due to less heroin use and less HIV-risk behavior; reduced arrests) to maintain support among funding agencies and the public. Promote the program as a regular part of the treatment continuum for heroin-addicted individuals.
Contact the InnovatorRobert P. Schwartz, MD
Medical Director/Senior Research Scientist
Friends Research Institute, Inc.
1040 Park Avenue, Suite 103
Baltimore, MD 21201
(410) 837-3977, ext. 276
Innovator DisclosuresDr. Schwartz has not indicated whether he has financial interests or business or professional affiliations relevant to the work described in this profile; however, information on funders is available in the Funding Sources section.
References/Related ArticlesKelly SM, Schwartz RP, O’Grady KE, et al. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial. J Addict Med. 2012;6(2):145-52. [PubMed]
Schwartz RP, Kelly SM, O’Grady KE, et al. Randomized trial of standard methadone treatment compared to initiating methadone without counseling: 12-month findings. Addiction. 2012;107(5):943-52. [PubMed]
National Institute on Drug Abuse. Principles of drug addiction treatment: a research-based guide.
Bethesda (MD): U.S. Department of Health and Human Services, National Institutes of Health. December 2012. NIH Publication No. 12-4180. Available at: http://www.drugabuse.gov/PODAT/.
Schwartz RP, Highfield DA, Jaffe JH, et al. A randomized controlled trial of interim methadone maintenance. Arch Gen Psychiatry. 2006;63(1):102-9. [PubMed]
Schwartz RP, Jaffe JH, Highfield DA, et al. A randomized controlled trial of interim methadone maintenance: 10-month follow-up. Drug Alcohol Depend. 2007;86(1):30-6. [PubMed]
Teagle S. Interim methadone raises odds of enrolling in comprehensive treatment: patients reduced heroin abuse and criminal activity while awaiting admission to a treatment program.
Bethesda (MD): U.S. Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse. 2007;21(3). NIDA Notes. Available at: http://www.drugabuse.gov/NIDA_notes/NNvol21N3/interim.html.
5 Federal Register, title 21 (1993) (codified at 58 CFR §495, pt 291).
6 To be eligible for interim methadone treatment, an applicant must first be eligible for a methadone treatment program, and there must be no such available programs within a reasonable geographic area and no programs that will have openings for a new patient within 14 days. To qualify for a methadone treatment program, the applicant must be addicted to an opioid drug at least 1 year before admission and be at least 18 years of age (or must meet Federal and State requirements for younger admission). A physician can invoke exception to the 1-year opioid-addiction criterion for one of the following: (1) The applicant was released from a correctional facility within 6 months of applying for treatment admission, (2) the applicant was previously treated at a methadone treatment program, (3) the program physician certifies that the applicant is pregnant, or (4) the underage applicant has undergone two attempts at detoxification or outpatient psychosocial treatment for addiction.
7 These intake procedures are the same as those required for patients entering the full-service methadone treatment program. Therefore, patients transferring from interim methadone maintenance into the full-service methadone treatment program are only required to submit to a urine screen before being admitted to the full-service methadone treatment program.
Schwartz RP, Jaffe JH, O'Grady KE, et al. Interim methadone treatment: impact on arrests. Drug Alcohol Depend. 2009;103(3):148-54. [PubMed]
Schwartz RP, Kelly SM, O'Grady KE, et al. Interim methadone treatment compared to standard methadone treatment: 4-month findings. J Subst Abuse Treat. 2011;41(1):21-9. [PubMed]
Kelly SM, Schwartz RP, O’Grady KE, et al. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial. J Addict Med. 2012;6(2):145-52. [PubMed]
Schwartz RP, Kelly SM, O’Grady KE, et al. Randomized trial of standard methadone treatment compared to initiating methadone without counseling: 12-month findings. Addiction. 2012;107(5):943-52. [PubMed]
Schwartz RP, Jaffe JH, O'Grady KE, et al. Scaling-up interim methadone maintenance: treatment for 1,000 heroin-addicted individuals. J Subst Abuse Treat. 2009;37(4):362-7. Epub 2009 Jun 21. [PubMed]
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Original publication: November 24, 2008.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: January 29, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: January 17, 2014.
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