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Intervention Summary

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Interim Methadone Maintenance

Interim Methadone Maintenance, also known as Interim Maintenance or IM, is a simplified methadone treatment program for opioid-dependent adults who are on waiting lists for comprehensive methadone treatment. IM consists of a daily, individually determined methadone dose, administered by a nurse, plus emergency counseling for up to 120 days. U.S. Federal regulations permit methadone treatment programs (MTPs) to provide IM to adults who seek treatment but, due to limited program capacity, cannot be admitted within 14 days. The regulations specify that (1) only public or nonprofit MTPs can provide IM; (2) patients receive counseling with IM only for emergencies or during times of crisis (e.g., serious medical problem, relationship issues, temporary loss of housing), although this occurs on an infrequent basis; and (3) patients must undergo limited drug testing. IM aims to facilitate entry into MTPs and reduce heroin use and criminal behavior by capitalizing on the motivation of the individual seeking treatment and providing help at the time of the request.

Descriptive Information

Areas of Interest Substance abuse treatment
Outcomes Review Date: October 2008
1: Heroin use
2: Entry into a comprehensive methadone treatment program
3: Criminal behaviors
Outcome Categories Crime/delinquency
Drugs
Treatment/recovery
Ages 26-55 (Adult)
Genders Male
Female
Races/Ethnicities Black or African American
Hispanic or Latino
White
Settings Outpatient
Geographic Locations Urban
Suburban
Implementation History The first use of methadone treatment without counseling for individuals on waiting lists for the U.S. Methadone Treatment Program was in Chicago, Illinois, in 1969-1970. During the AIDS epidemic in the 1980s, Drs. Vincent Dole and Don Des Jarlais received an investigational new drug application (IND) permit from the Food and Drug Administration to study such an approach, which these authors termed "Interim Maintenance," with heroin-addicted individuals on MTP waiting lists in New York City (see Studies and Materials Reviewed, Yancovitz et al., 1991). In 1993, Federal regulations were approved that permitted IM (Federal Register, title 21, 1993). In 2001-2003, the National Institute on Drug Abuse (NIDA) supported a study in Baltimore, Maryland, that provided IM treatment to 199 adults as part of an opioid treatment program (OTP) with a comparison group of 120 individuals on an MTP waiting list. Subsequently, in 2005-2006, the Center for Substance Abuse Treatment (CSAT) provided funding for six OTPs in Baltimore, Maryland, to provide IM treatment to more than 1,000 patients. Four MTPs in Baltimore continue to provide IM treatment through local support.
NIH Funding/CER Studies Partially/fully funded by National Institutes of Health: Yes
Evaluated in comparative effectiveness research studies: No
Adaptations No population- or culture-specific adaptations of the intervention were identified by the developer.
Adverse Effects No adverse effects, concerns, or unintended consequences were identified by the developer.
IOM Prevention Categories IOM prevention categories are not applicable.

Quality of Research
Review Date: October 2008

Documents Reviewed

The documents below were reviewed for Quality of Research. The research point of contact can provide information regarding the studies reviewed and the availability of additional materials, including those from more recent studies that may have been conducted.

Study 1

Yancovitz, S. R., Des Jarlais, D. C., Peyser, N. P., Drew, E., Friedman, P., Trigg, H. L., & Robinson, J. W. (1991). A randomized trial of an interim methadone maintenance clinic. American Journal of Public Health, 81(9), 1185-1191.  Pub Med icon

Study 2

Schwartz, R. P., Highfield, D. A., Jaffe, J. H., Brady, J. V., Butler, C. B., Rouse, C. O., et al. (2006). A randomized controlled trial of interim methadone maintenance. Archives of General Psychiatry, 63(1), 102-109.  Pub Med icon

Schwartz, R. P., Jaffe, J. H., Highfield, D. A., Callaman, J. M., & O'Grady, K. E. (2007). A randomized controlled trial of interim methadone maintenance: 10-month follow-up. Drug and Alcohol Dependence, 86(1), 30-36.  Pub Med icon

Supplementary Materials

Baltimore Substance Abuse System. (2006). Interim methadone treatment to reduce waiting list. Final report for Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment Grant No. 1H79TI16097-01. Baltimore, MD: Author.

Friedman, P., Des Jarlais, D. C., Peyser, N. P., Nichols, S. E., Drew, E., & Newman, R. G. (1994). Retention of patients who entered methadone maintenance via an interim methadone clinic. Journal of Psychoactive Drugs, 26(2), 217-221.  Pub Med icon

Highfield, D. A., Schwartz, R. P., Jaffe, J. H., & O'Grady, K. E. (2007). Intravenous and intranasal heroin-dependent treatment-seekers: Characteristics and treatment outcome. Addiction, 102(11), 1816-1823.  Pub Med icon

Overview of Interim Methadone Treatment quality assurance procedures. (2008).

Outcomes

Outcome 1: Heroin use
Description of Measures Heroin use was measured by the following:

  • Toxicological analysis of urine samples collected biweekly under observation by program staff (thin layer chromatography with confirmation by gas chromatography/mass spectrometry performed by an independent laboratory)
  • Toxicological analysis of urine samples collected at 120-day and 10-month follow-ups (enzyme multiplied immunoassay test [EMIT] by an independent laboratory)
  • Self-report responses to the Addiction Severity Index (ASI), a measure of problem severity that provides composite scores for seven domains: medical, legal, employment, drug, alcohol, family, and psychological functioning; composite scores of 0 to 1 are generated for each domain, with higher scores reflecting greater problem severity
  • Oral swabs collected by a research assistant at 6 and 7 weeks from study entry (for participants still enrolled in the interim treatment)
Key Findings In one study, IM participants had a significant reduction in heroin use at 30 days from study enrollment compared with a control group who received biweekly follow-up interviews and free condoms and provided urine samples (p < .001).

In another study, IM participants reported significantly fewer days of heroin use at 120-day and 10-month follow-ups compared with wait-list controls (p < .001).
Studies Measuring Outcome Study 1, Study 2
Study Designs Experimental
Quality of Research Rating 3.7 (0.0-4.0 scale)
Outcome 2: Entry into a comprehensive methadone treatment program
Description of Measures The Interim Treatment Study Wait-List Experience Questionnaire, a self-report instrument, was used to assess treatment enrollment status at the follow-up interview. Examples of items are "Right now, are you getting any outpatient treatment?" (yes/no) and "How long have you been receiving the treatment [outpatient drug-free, outpatient detox, methadone maintenance, etc.]?"
Key Findings A significantly greater percentage of participants assigned to IM (76%) reported entering a comprehensive methadone treatment program compared with wait-list controls (21%) during the 120-day evaluation period (p < .001). At 10-month follow-up, 65% of IM participants reported being enrolled in a comprehensive methadone treatment program, compared with 28% of wait-list controls (p < .001).
Studies Measuring Outcome Study 2
Study Designs Experimental
Quality of Research Rating 3.3 (0.0-4.0 scale)
Outcome 3: Criminal behaviors
Description of Measures Criminal behaviors were assessed using the ASI, a self-report measure of problem severity that provides composite scores for seven domains: medical, legal, employment, drug, alcohol, family, and psychological functioning. The legal subscales were used for this outcome. Examples of items are amount of money spent on drugs in the past 30 days, amount of illegal income in the past 30 days, and days of illegal activity in the past 30 days. Responses ranged from 0 to 1, with higher scores reflecting greater problem severity.
Key Findings At 120-day follow-up, IM participants reported spending less money on drugs (p < .001) and receiving less illegal income than wait-list controls (p < .02). Sustained benefits were seen at 10-month follow-up, when IM participants reported spending less money on drugs (p < .001), obtaining less money from illegal activity (p < .01), and doing illegal activities on fewer days (p < .001).
Studies Measuring Outcome Study 2
Study Designs Experimental
Quality of Research Rating 3.7 (0.0-4.0 scale)

Study Populations

The following populations were identified in the studies reviewed for Quality of Research.

Study Age Gender Race/Ethnicity
Study 1 26-55 (Adult) 79% Male
21% Female
55% Hispanic or Latino
35% Black or African American
10% White
Study 2 26-55 (Adult) 60% Male
40% Female
93% Black or African American
6% White
1% Hispanic or Latino

Quality of Research Ratings by Criteria (0.0-4.0 scale)

External reviewers independently evaluate the Quality of Research for an intervention's reported results using six criteria:

  1. Reliability of measures
  2. Validity of measures
  3. Intervention fidelity
  4. Missing data and attrition
  5. Potential confounding variables
  6. Appropriateness of analysis

For more information about these criteria and the meaning of the ratings, see Quality of Research.

Outcome Reliability
of Measures
Validity
of Measures
Fidelity Missing
Data/Attrition
Confounding
Variables
Data
Analysis
Overall
Rating
1: Heroin use 3.9 3.8 4.0 3.0 4.0 3.8 3.7
2: Entry into a comprehensive methadone treatment program 2.0 2.0 4.0 3.5 4.0 4.0 3.3
3: Criminal behaviors 3.5 3.0 4.0 3.5 4.0 4.0 3.7

Study Strengths

The ASI, urine test, and oral swab measures all have good psychometric properties. Care was taken to deliver the intervention with fidelity, and the fidelity appears to be good. The investigators conducted an excellent analysis of possible confounding variables, and the use of randomization in both studies minimizes concerns about confounds. Both studies employed excellent analytic strategies that were appropriate for the study designs.

Study Weaknesses

The Interim Treatment Study Wait-List Experience Questionnaire used in one study has face validity, but complete information on reliability and validity was not provided. Although the investigators addressed attrition and missing data, they did not attempt to model missing data.

Readiness for Dissemination
Review Date: October 2008

Materials Reviewed

The materials below were reviewed for Readiness for Dissemination. The implementation point of contact can provide information regarding implementation of the intervention and the availability of additional, updated, or new materials.

Overview of Interim Methadone Treatment quality assurance procedures. (2008).

Schwartz, R. P., & Jaffe, J. H. (2008). Interim Methadone Treatment implementation manual. Baltimore, MD: Friends Research Institute.

Readiness for Dissemination Ratings by Criteria (0.0-4.0 scale)

External reviewers independently evaluate the intervention's Readiness for Dissemination using three criteria:

  1. Availability of implementation materials
  2. Availability of training and support resources
  3. Availability of quality assurance procedures

For more information about these criteria and the meaning of the ratings, see Readiness for Dissemination.

Implementation
Materials
Training and Support
Resources
Quality Assurance
Procedures
Overall
Rating
2.5 1.3 2.5 2.1

Dissemination Strengths

The manual provides a succinct overview of the intervention and basic steps for implementation. The developer is available to answer implementers' questions via e-mail and telephone. Strategies are provided to ensure a smooth client transition from this interim program to a more comprehensive methadone program. Guidance for monitoring intervention fidelity and outcomes is provided.

Dissemination Weaknesses

The program lacks a detailed, step-by-step implementation guide. Although implementers would need little training on methadone maintenance procedures, no guidance or training is offered on how to integrate this add-on interim program into existing organizational structures or how to implement quality assurance procedures. Information on suggested quality assurance procedures is limited.

Costs

The cost information below was provided by the developer. Although this cost information may have been updated by the developer since the time of review, it may not reflect the current costs or availability of items (including newly developed or discontinued items). The implementation point of contact can provide current information and discuss implementation requirements.

Item Description Cost Required by Developer
Intervention manual Contact the developer Yes
Phone or email consultation Free No
On-site consultation Contact the developer No
Contact Information

To learn more about implementation or research, contact:
Robert P. Schwartz, M.D.
(410) 837-3977 ext 276
rschwartz@friendsresearch.org

Consider these Questions to Ask (PDF, 54KB) as you explore the possible use of this intervention.