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PubMedDate not supplied

A framework for selecting performance measures for opioid treatment programs.

As a result of new federal regulations released in early 2001 that move the monitoring and evaluation of opioid treatment programs from a government regulation to an accreditation model, program staff members are now being challenged to develop performance measurement systems that improve care and service. Using measurement selection criteria is the first step in developing a performance measurement system as a component of an overall quality management (QM) strategy. Opioid treatment programs can "leapfrog" the development of such systems by using lessons learned from the healthcare quality industry. This article reviews performance measurement definitions, proposes performance measurement selection criteria, and makes a business case for Internet automation and accessibility. Performance measurement sets that are appropriate for opioid treatment programs are proposed, followed by a discussion on how performance measurement can be used within a comprehensive QM program. It is hoped that through development, adoption, and implementation of such a performance measurement program, treatment for clients and their families will continuously improve.

Accreditation↗

PubMed2001

New Federal Regulations for Improving Quality in Opioid Treatment Programs.

The U.S. Food and Drug Administration (FDA) has enforced federal requirements related to the use of methadone since 1972; regulations essentially have not changed for nearly 30 years. With Congress' recently released federal regulations for opioid treatment programs (OTPs), however, oversight of OTPs has shifted from the FDA to the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA's Center for Substance Abuse Treatment developed guidelines for accreditation agencies such as the Joint Commission on Accreditation of Healthcare Organizations and The Rehabilitation Accreditation Commission...CARF to develop standards for OTPs. Preliminary findings show that OTPs are indeed able to meet these accreditation standards. This article reviews the need for the changes, the history of methadone treatment oversight, the development of accreditation requirements, stakeholders' initial response to the proposed regulations, and performance domains of importance to OTPs.

Journal Article↗

PubMed2000

A case for addressing cigarette use in methadone and other opioid treatment programs.

Most persons attending drug treatment smoke cigarettes. They will eventually experience predictable, but devastatingly high, tobacco-related mortality. Recent studies indicate that many clients are ready to quit smoking and that quitting does not threaten progress made in treatment. Methadone and other opioid treatment providers are in an excellent position to address tobacco use among their clients. The present paper describes the prevalence of smoking among methadone clients, reviews promising interventions, and describes how programs can implement a systematic approach to smoking cessation that includes creating a cue system for identifying smokers, providing brief on-site intervention, and arranging follow-up or more intensive treatment.

Humans↗

PubMed2006

Characteristics of U.S. substance abuse treatment facilities adopting buprenorphine in its initial stage of availability.

This study examined the adoption of buprenorphine for the treatment of opiate dependence among U.S. substance abuse treatment facilities and their characteristics at the time of the initial availability of the medication. Data come from a 2003 national survey of all substance abuse treatment facilities in the U.S. Out of our sample of 13,060 facilities, 5.5% of facilities reported they offered buprenorphine. Not unexpectedly, the prevalence was higher in certified opioid treatment programs (11.3%) compared to other facilities (4.6%). For opioid treatment programs, offering Naltrexone (OR=8.34, 95% CI=5.53, 12.58) and offering medically supervised withdrawal (OR=2.76, 95% CI=1.38, 5.52) were independent and robust predictors of offering buprenorphine. These same variables were independent predictors for the non-opioid treatment programs as well (Naltrexone, OR=14.32, 95% CI=7.85, 26.10; and medically supervised withdrawal services, OR=4.42, 95% CI=3.01, 6.49). Our results suggest that the adoption of buprenorphine soon after the Food and Drug Administration approved its use for treatment of opioid dependence and the shipping of the medication commenced was associated with facilities already offering pharmacotherapies such as Naltrexone and medically assisted withdrawal. These findings provide baseline data to track the adoption of buprenorphine by substance abuse treatment programs in future years.

Buprenorphine↗

PubMed2003

Opioid drugs in maintenance and detoxification treatment of opiate addiction; addition of buprenorphine and buprenorphine combination to list of approved opioid treatment medications. Interim final rule.

This interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certified and registered opioid treatment programs. The Food and Drug Administration (FDA) recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] (buprenorphine in fixed combination with naloxone) for the treatment of opiate dependence. These two products will join methadone and ORLAAM[reg] as medications that may be used in opioid treatment programs for the maintenance and detoxification treatment of opioid dependence. Opioid treatment programs that choose to use these new products in the treatment of opioid dependence will adhere to the same Federal treatment standards established for methadone and ORLAAM[reg]. The Secretary invites public comments on this action.

Buprenorphine↗

PubMed2004

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience.

In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16 mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.

Administration, Sublingual↗

PubMed2005

Methadone medical maintenance in primary care. An implementation evaluation.

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 experimental programs have been studied. OBJECTIVE: To evaluate the implementation of the first methadone medical maintenance program established outside a research setting. DESIGN: One-year program evaluation. SETTING: A public hospital and a community opioid treatment program. PARTICIPANTS: Methadone patients with >1 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, treatment 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 stability 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 physician satisfaction were high, and physician attitudes toward methadone maintenance treatment became more positive (P=.007). CONCLUSIONS: Methadone medical maintenance is complex to arrange but feasible outside a research setting, and can result in good clinical outcomes.

Adult↗

PubMed2026

Qualitative evidence of service user experiences and perspectives on long-acting injectable buprenorphine for opioid treatment - a scoping review.

BACKGROUND: There is substantial literature on opioid treatment program (OTP) formulations and how they relate to the pharmacotherapy service user experience. As a newer formulation, less is known about service user experiences of long-acting injectable buprenorphine (LAIB). The aim of this scoping review is to map the qualitative evidence and gaps in the literature on service user experiences and perspectives of LAIB. METHODS: Our search strategy included Medline, Embase, PsycINFO, CINAHL, Scopus and Web Science, and citation chaining, from January 2016 to June 2025. Studies were included if reporting qualitative descriptions of LAIB service user experiences of treatment for opioid dependence, inclusive of qualitative, mixed methods (description of qualitative data only), case reports and English language. Articles were screened by two reviewers. A living experience first author led the analysis using inductive coding and thematic analysis, to produce a descriptive summary of synthesised findings alongside key study characteristics and quality appraisal, adhering to the Systematic reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR) checklist. RESULTS: After screening 838 titles/abstracts and reviewing 150 full texts, 40 studies met the eligibility criteria. All were conducted in high income countries, principally the US (n=12); Australia (n=10); and England and Wales (n=9). We identified five themes: Navigating LAIB treatment; Embodied and relational effects of LAIB; Impact and role of the service provider; Narratives of harm reduction and recovery; Stigma and criminalisation. LAIB was commonly experienced as increasing convenience, stability and freedom from daily supervised dosing, enabling improved work, travel, privacy and social participation. Reduced clinic/dosing contact often lessened enacted stigma and treatment burden. However, experiences were heterogenous. Some participants described injection-site discomfort, uncertainty about dose adequacy, reduced flexibility once injected, and ambivalence about LAIB effects. There was inconsistency in LAIB service user reports on service connection, isolation and psychosocial support. Treatment experiences were strongly shaped by provider practices. CONCLUSIONS: Findings underscore the need for integrated, flexible, harm-reduction oriented and person-centred LAIB treatment models that prioritise choice, autonomy and therapeutic relationships to maximise benefit for service users. However, evidence of LAIB service user experiences is concentrated in high-income countries, and the absence of perspectives from low- and middle-income country settings represents a substantial gap in the evidence base.

LAIB↗

PubMed2003

Safety of injectable opioid maintenance treatment for heroin dependence.

BACKGROUND: There is a growing debate about injectable opioid treatment programs in many Western countries. This is the first placebo-controlled study of the safety of injectable opioids in a controlled treatment setting. METHODS: Twenty-five opioid-dependent patients on intravenous (IV) heroin or IV methadone maintenance treatment were randomly assigned to either their individual prescribed IV maintenance dose or placebo. Acute drug effects were recorded, focusing on electrocardiography, respiratory movements, arterial blood oxygen saturation, and electroencephalography (EEG). RESULTS: After heroin injection, marked respiratory depression progressing to a Cheyne-Stokes pattern occurred. Peripheral arterial blood oxygenation decreased to 78.9 +/- 8.7% (mean +/- SD) ranging from 52%-90%. During hypoxia, 7 of the 16 subjects experienced intermittent and somewhat severe bradycardia. Five subjects exhibited paroxysmal EEG patterns. After methadone injection, respiratory depression was less pronounced than after heroin injection. No relevant bradycardia was noted. CONCLUSIONS: Opioid doses commonly prescribed in IV opioid treatment induce marked respiratory and circulatory depression, as well as occasionally irregular paroxysmal EEG activity. Further studies are needed to optimize the clinical practice of IV opioid treatment to prevent serious complications. Moreover, the extent of the observed effects raises questions about the appropriateness of IV opioid treatment in the present form.

Adult↗

PubMed2004

Faculty development in small-group teaching skills associated with a training course on office-based treatment of opioid dependence.

The Drug Addiction Treatment Act of 2000 (DATA-2000) allows qualified physicians to treat opioid-dependent patients with schedule III-V medications, such as buprenorphine, in practices separate from licensed, accredited opioid treatment programs. Physicians may attain this qualification by completing 8-hours of training in treating opioid dependence. This paper describes the evaluation of a faculty development workshop designed to enhance teaching skills of small-group facilitators involved with DATA-2000 training sessions. This workshop coached the facilitators on their teaching roles in the DATA-2000 session through experiential practice of patient- case discussions related to treatment of opioid-dependence. Descriptive questionnaires evaluated the value of the workshop. Twenty-six facilitators participated in the workshops. Paired mean score responses for specific teaching skill abilities demonstrated statistically significant improvement in all categories. Evaluation of the DATA-2000 training session small-group facilitators was uniformly positive. This faculty development workshop was successful in improving teaching skills for our small-group faculty facilitators.

Adult↗

PubMed2006

Experiences of a national sample of qualified addiction specialists who have and have not prescribed buprenorphine for opioid dependence.

The limited availability of medication-assisted treatment has created a treatment gap leaving many opioid dependent individuals without access to appropriate treatment. Survey data from a national random sample of 545 addictions physicians with waivers to provide buprenorphine treatment under The Drug Addiction Treatment Act of 2000 are presented. During the first year, an estimated 63,204 opioid dependent patients were treated with buprenorphine; many were dependent on prescription opioids and were new to drug treatment. Prescribing physicians reported high treatment effectiveness and patient satisfaction, with minimal adverse reactions or evidence of diversion. However, many waivered physicians had not provided buprenorphine treatment. Prescribers identified challenges such as induction logistics, recordkeeping requirements, the 30-patient limit, DEA involvement, and limited patient compliance. Buprenorphine treatment could potentially reduce the treatment gap by providing safe and effective treatment for opioid dependence and by attracting patients who do not typically seek care at opioid treatment programs.

Attitude of Health Personnel↗

PubMed2004

Evaluation of levo-alpha-acetylmethdol (LAAM) as an alternative treatment for methadone maintenance patients who regularly experience withdrawal: a pharmacokinetic and pharmacodynamic analysis.

The aim of this study was to determine if substitution of daily methadone with second daily levo-alpha-acetylmethadol (LAAM) would convert non-holders on methadone into holders on LAAM, and to compare plasma concentration-time profiles of (R)-methadone with LAAM and its two metabolites. Sixteen stable methadone maintenance treatment participants (non-holders, n = 8) were randomly allocated to continue methadone for 3 months or switch to LAAM for 3 months, and then crossed over to the alternative drug for 3 months. At steady state, there were two testing sessions (24 h for methadone and 48 h for LAAM), during which opioid withdrawal severity, respiration rate and pupil diameter were measured 10-11 times and venous blood was collected 13-15 times. Ten age- and gender-matched controls underwent one 48-h test session. Areas under the withdrawal severity score versus time curve (AUC(0-47) hours for LAAM and controls; AUC(0-24) x 2 for methadone) were similar in holders on methadone and LAAM (P = 0.62), but were greater in non-holders when they were taking methadone than LAAM (P < 0.001). Respiratory depression and pupillary constriction were similar for LAAM and methadone. In comparison to (R)-methadone, plasma nor- and dinor-LAAM concentrations fluctuated little over the dosing interval. LAAM converted methadone non-holders into LAAM holders. LAAM may therefore be useful in selected MMT non-holders and improve retention in opioid treatment programs.

Adult↗

PubMed2004

Consensus statement on office-based treatment of opioid dependence using buprenorphine.

Buprenorphine and buprenorphine/naloxone (BUP) are newly approved for office-based treatment of opioid dependence. Federal and non-federal regulatory and monitoring agencies, national and international researchers, national professional organizations, researchers involved in monitoring, opioid treatment programs and the pharmaceutical industry met to synthesize and disseminate practical information to guide training, practice, monitoring, regulation and evaluation efforts with these medications. We performed a review of the literature, training curricula and practice guidelines and commissioned manuscripts describing recently completed, or still in progress, studies or field experiences with BUP treatment. A consensus process generated fifteen statements: (1) The federal government should collect baseline data on opioid-related deaths and morbidity to assess the effect of BUP on public health, (2) the patient limit for group practices should apply to individual physicians rather than group practices, (3 and 4) telephone and Internet-based physician and pharmacist support is needed, (5) clinicians who provide psychosocial services to opioid dependent patients should be informed of the role of BUP, (6) opioid-dependent patients should be instructed to present for induction in mild withdrawal, (7) the existing Center for Substance Abuse Treatment guidelines provide a reasonable induction protocol, (8) physicians should be prepared to use ancillary medications with BUP induction, (9) a physician or nurse must be available to the patient during the induction period, (10) concurrent counseling and support services are necessary, (11) detoxification without appropriate followup addiction treatment leads to rapid relapse and is not as effective as maintenance, (12) pregnant opioid-dependent women should be treated using good clinical practice including specialist addiction care and prenatal care, (13) BUP induction and withdrawal treatment may benefit from different designations for payment, (14) take-home medication options should be tailored to patients' needs, (15) there is a need for clinical and policy research in unique patient populations.

Ambulatory Care↗

PubMed2005

The practice of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment?

Office-based buprenorphine holds the promise of bringing patients who have never received pharmacotherapy into treatment. In a cross-sectional and longitudinal analysis, we compared patients entering a clinical trial of buprenorphine in a Primary Care Clinic (PCC) and those entering a local Opioid Treatment Program (OTP) and we compared the clinical characteristics and treatment outcomes of PCC patients with no history of methadone treatment (new-to-treatment) to those with prior methadone treatment. PCC subjects (N=96) were enrolled in a 26-week randomized clinical trial of office-based buprenorphine/naloxone provided in a PCC. OTP subjects (N=94) were enrolled in methadone maintenance during the same time period. PCC subjects compared with OTP subjects were more likely to be male (77% versus 55%, p<0.01), full-time employed (46% versus 15%, p<0.001), have no history of methadone treatment (46% versus 61%, p<0.05), have fewer years of opioid dependence (10 versus 15, p<0.001), and lower rates of injection drug use (IDU) (44% versus 60%, p=0.03). The new-to-treatment PCC subjects were younger (36 years versus 41 years, p=0.001), more likely to be white (77% versus 57%, p=0.04), had fewer years of opioid dependence (7 versus 14, p<0.001), were less likely to have a history of IDU (35% versus 54%, p=0.07), and had lower rates of hepatitis C (25% versus 61%, p=0.002) than subjects with prior methadone treatment. Abstinence and treatment retention were comparable in both groups. The results suggest that office-based treatment of opioid dependence is associated with new types of patients entering into treatment. Treatment outcomes with buprenorphine in a PCC do not vary based on history of prior methadone treatment.

Adolescent↗

PubMed2004

Processes of care during a randomized trial of office-based treatment of opioid dependence in primary care.

Improving office-based treatment of opioid dependence requires an evaluation of processes of care. We evaluated the care provided by physicians to opioid dependent patients during a trial of office-based methadone maintenance. We conducted chart audits and a focus group. Audits identified lapses in monitoring of urine toxicology results and paperwork completion. The focus group identified the logistics of dispensing, the receipt of urine toxicology results, difficulties arranging psychiatric services, communications with the opioid treatment program, and non-adherence to medication as problematic. Strategies to support logistical aspects of office-based care should be developed. Chart audits and mentoring should be considered as a mechanism to foster quality care. These processes of care are likely to require attention for treatment using methadone or buprenorphine.

Adolescent↗

PubMed2006

Safety, efficacy, and tolerability of nelfinavir-containing antiretroviral therapy for patients coinfected with HIV and hepatitis C undergoing methadone maintenance.

The safety, efficacy, and tolerability of nelfinavir (NFV)-containing antiretroviral therapy were evaluated in patients coinfected with HIV and hepatitis C undergoing methadone maintenance at an urban outpatient opioid treatment program serving a minority adult population. Eligibility covered methadone-maintained patients coinfected with HIV and hepatitis C who had received or were currently receiving NFV. The yield was 51 case patients. Parameters examined looked into safety, efficacy, and tolerability. Nelfinavir was discontinued in 2 patients for liver function abnormalities but resumed in 1 patient. One patient developed laboratory abnormalities during NFV therapy that were not present before NFV therapy; in 12 case patients, pre-NFV therapy liver function abnormalities resolved completely during NFV therapy. There was a statistically significant increase in CD4 count during NFV therapy. Viral load decreased or was unchanged in 10 case patients and increased in 8, of whom 5 had a CD4 count increase during NFV therapy. Three patients had diarrhea and 4 patients had constipation. Nelfinavir was not discontinued -- neither was dose adjusted -- in any of these patients. Patients who had received NFV > or =36 months had a smaller increase in mean methadone dose as compared with patients who had received NFV <36 months. The results show that NFV is safe, efficacious, and well tolerated.

Adult↗

PubMed2006

A randomized controlled trial of interim methadone maintenance: 10-Month follow-up.

This study compares interim maintenance (IM) to a waiting list condition at an opioid treatment program (OTP). As defined by US federal regulations, IM provides observed methadone dosing and emergency counseling only for a maximum of 120 days. Three hundred and nineteen individuals enrolled on an OTP waiting list were randomly assigned on a 3:2 basis to either IM or waiting list control. Outcomes were measured at OTP entry (or at 4 months from baseline for those who did not enter treatment), and 6 months thereafter. At the second follow-up, 129 (64.8%) of the IM participants reported being enrolled in an OTP, versus 33 (27.5%) of the controls, p<.001. Significant treatment conditionxtime interaction effects occurred for heroin and cocaine use (both p's<.001) and the ASI Legal composite score (p<.001). Moreover, a significant difference occurred between conditions at the second follow-up for heroin-positive drug tests (interim 48.1% versus control 72.3%, p=.001) but not for cocaine-positive drug tests. At 10 months after study enrollment, there are sustained benefits of IM as compared to waiting list in terms of increased treatment entry and reduced heroin use and criminal behavior.

Adult↗

PubMed2006

The costs of pursuing accreditation for methadone treatment sites: results from a national study.

The use of accreditation has been widespread among medical care providers, but accreditation is relatively new to the drug abuse treatment field. This study presents estimates of the costs of pursuing accreditation for methadone treatment sites. Data are from 102 methadone treatment sites that underwent accreditation as part of the Center for Substance Abuse Treatment's evaluation of the Opioid Treatment Program Accreditation Project. The analysis represents the most comprehensive analysis of the costs of pursuing accreditation by a health care provider. Importantly, it is the first analysis of the costs of pursuing accreditation by drug treatment providers. Policy makers and drug treatment providers can use this analysis to plan the labor requirements and costs of future accreditation initiatives.

Accreditation↗