Short communication
Long-term outcomes of office-based buprenorphine/naloxone maintenance therapy

https://doi.org/10.1016/j.drugalcdep.2009.07.013Get rights and content

Abstract

Background

Buprenorphine/naloxone was approved by the FDA for office-based opioid maintenance therapy (OMT), with little long-term follow-up data from actual office-based practice. 18-Month outcome data on the office-based use of buprenorphine/naloxone (bup/nx) and the impact of socioeconomic status and other patient characteristics on the duration and clinical effects of bup/nx are reported.

Methods

This retrospective chart review and cross-sectional telephone interview provide treatment retention of opioid-dependent patients receiving bup/nx-OMT in an office-based setting. 176 opioid-dependent patients from two different socioeconomic groups (high and low SES) were begun on bup/nx, started intensive outpatient treatment, and followed-up after a minimum of 18 months (18–42 months) by telephone interview to assess treatment outcome.

Results

110 subjects (67%) completed the interview, 77% remained on bup/nx with no difference in retention between high and low SES groups. Those on bup/nx at follow-up were more likely to report abstinence, to be affiliated with 12-step recovery, to be employed and to have improved functional status.

Conclusions

Bup/nx-OMT is a viable treatment option and when coupled with a required abstinence oriented addiction counseling program is effective in promoting abstinence, self-help group attendance, occupational stability, and improved psychosocial outcomes in both low SES and high SES patient populations over an 18–42-month period.

Introduction

The buprenorphine/naloxone (bup/nx) sublingual tablet was approved by the FDA in 2002 and in early 2003 became available for use in the United States for office-based opioid maintenance therapy (OMT) for opioid-dependent patients (Johnson et al., 2003). This enabled major changes in the way opiate addiction is treated in the United States (Fiellin and O’Connor, 2002b, Fiellin et al., 2001, Jaffe and O’Keeffe, 2003). Substantial pre-release research demonstrated the safety, efficacy and comparability of bup/nx with previous forms of OMT like methadone. bup/nx also appears to have a good safety profile compared to methadone maintenance including a decreased risk with overdose or diversion, ease of dosage titration, possible ease and brevity for tapering, and possibly a decreased impact on the patient's cognitive function (Carrieri et al., 2006, Fiellin et al., 2004, Fiellin and O’Connor, 2002a, Fudala et al., 2003, Harris et al., 2000, Jasinski et al., 1978, Johnson et al., 2000, Johnson et al., 1992, Ling et al., 1998, Ling et al., 1996, Mattick et al., 2003, Mendelson and Jones, 2003, Simoens et al., 2005, Strain et al., 1994, Walsh and Eissenberg, 2003).

This favorable safety profile of buprenorphine and the ability to move opioid agonist therapy to an office rather than addiction clinic setting has resulted in significant prescribing and a growing body of post-release bup/nx research and clinical experience (Bouchez and Vignau, 1998). Post-release studies have shown bup/nx to significantly reduce opioid withdrawal symptoms, improve retention in substance abuse treatment, and improve treatment completion roughly similar to methadone treatment (Amass et al., 1994, Caldiero et al., 2006, Fiellin et al., 2002, Gibson et al., 2003, Johnson et al., 1995, Krook et al., 2002, Moore et al., 2007, Stein et al., 2005, Auriacombe et al., 1994, Giacomuzzi et al., 2005, Johnson et al., 2000, Kakko et al., 2003, Kosten et al., 1993, Mattick et al., 2003, O’Connor et al., 1998, Strain et al., 1994).

There are several areas in which more research on OMT with bup/nx is needed including; outcomes with use in the actual private practice office setting, data on greater than 1 year follow-up (Alford et al., 2007, Fhima et al., 2001, Kornor et al., 2007, McLellan et al., 2000), and pre-induction patient characteristics as a predictor of long-term retention in treatment (Marsch et al., 2005). In addition very few studies have examined the long-term effectiveness of bup/nx in uninsured and underinsured populations (low socioeconomic status or low SES) (Mintzer et al., 2007).

This report provides outcome data on a large number of bup/nx maintained patients in an urban office setting with cross-sectional follow-up at a minimum of 18 months post-induction. Data include the impact of pre-treatment patient variables on patient outcomes including demographic, drug and alcohol use histories and socioeconomic status. The primary objective of the study was to assess retention on bup/nx treatment, drug use, morbidity from addictive disease and sobriety rates in 176 patients at least 18 months post-induction. The secondary objective was to analyze the impact of pre-induction patient characteristics including SES on the duration and outcome of bup/nx treatment at least 18 months post-induction.

Section snippets

Methods

The patient population consisted of 176 consecutively admitted opioid dependant adults age 19–65 who met the criteria for admission into the bup/nx treatment program (DSM-IV Opiate Dependence, multiple prior failed attempts at abstinence, lack of additional uncontrolled axis I diagnosis/psychosis, not homeless). Patients were admitted over a 30-month period of time. Initially only privately insured or full self-pay patients (the high SES group) were admitted to the bup/nx OMP. Starting in 2005

Results

Over 30 months 176 subjects were inducted on bup/nx and eligible for follow-up. 33% were female; 73% Caucasian, 21% Black, and 5% Hispanic, consistent with the overall racial characteristics of opioid-dependent patients in the region. 110 of 176 (63%) completed the follow-up telephone interview at least 18 months post-induction. Table 1 contains basic pre-induction demographic, drug use history, medical, legal, and psychosocial data. There were no significant differences in the baseline

Discussion

This study is one of the largest case series to date to report outcomes of office-based bup/nx maintenance with minimum 18-month follow-up data. The goals of the present study were to determine the proportion of subjects still using bup/nx at follow-up, to compare levels of functioning in continuously maintained bup/nx patients with those who dropped out, and to assess whether pre-treatment variables including SES were predictive of treatment retention.

At between 18 months and 4 years of

Role of funding source

There was funding provided for this research report by the Crile Medical Student Summer Research Fellowship of CWRU School of Medicine (A. Mace). Also support was provided to Dr. Merkin through the Special Fellowships in Addiction Medicine of the Cleveland VAMC. No other funding was provided for this study.

Contributors

T. Parran consulted on the study development, supervised data collection, and wrote the final manuscript. C. Adelman developed the study design, provided clinical supervision and medical records access, supervised the IRB proposal and supervised all data collection. A. Mace compiled all data and wrote the initial draft of the report. M. Pagano provided data supervision, data analysis, and manuscript writing and editing. R. Ionescu provided data supervision, data analysis, and manuscript writing

Conflict of interest

T. Parran is a member of the Speakers Bureau for ReckittBinckiser and a Buprenorphine Course Director and Faculty Member for ASAM, and a faculty mentor on the ASAM PCSS Buprenorphine web-service. C. Adelman is a member of the Speakers Bureau for ReckittBinckiser and a Buprenorphine Course Faculty Member for ASAM. B. Merkin has no disclosures to provide. R. Defranco has no disclosures to provide. A. Mace has no disclosure to provide. M. Pagano has no disclosures to provide. R. Ionescu has no

References (41)

  • J. Bouchez et al.

    The French experience—the pharmacist, general practitioner and patient perspective

    Eur. Addict. Res.

    (1998)
  • R.M. Caldiero et al.

    Inpatient initiation of buprenorphine maintenance vs. detoxification: can retention of opioid-dependent patients in outpatient counseling be improved?

    Am. J. Addict.

    (2006)
  • M.P. Carrieri et al.

    Buprenorphine use: the international experience

    Clin. Infect. Dis.

    (2006)
  • A. Fhima et al.

    Two-year follow-up of an opioid-user cohort treated with high-dose buprenorphine (Subutex)

    Ann. Med. Intern. (Paris)

    (2001)
  • D.A. Fiellin et al.

    Clinical practice. Office-based treatment of opioid-dependent patients

    N. Engl. J. Med.

    (2002)
  • D.A. Fiellin et al.

    New federal initiatives to enhance the medical treatment of opioid dependence

    Ann. Intern. Med.

    (2002)
  • D.A. Fiellin et al.

    Counseling plus buprenorphine–naloxone maintenance therapy for opioid dependence

    N. Engl. J. Med.

    (2006)
  • D.A. Fiellin et al.

    Treatment of heroin dependence with buprenorphine in primary care

    Am. J. Drug Alcohol. Abuse

    (2002)
  • D.A. Fiellin et al.

    Office-based treatment for opioid dependence: reaching new patient populations

    Am. J. Psychiatry

    (2001)
  • P.J. Fudala et al.

    Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone

    N. Engl. J. Med.

    (2003)
  • Cited by (100)

    • Medication-assisted therapies for opioid use disorders in patients with chronic pain

      2020, Journal of the Neurological Sciences
      Citation Excerpt :

      For example, one study compared methadone alone to methadone plus counseling and found that counseling provided a significant advantage over just methadone with the best outcomes from “enhanced counseling” (counseling plus individually tailored, on-site medical, psychiatric, employment, and family therapy services) [112]. There are some conflicting results, but it appears, that access to counseling also improves retention in office based buprenorphine clinics [113,114]. Based on a general review of this data, SAMHSA (substance abuse and mental health services association) has laid out guidelines for the administration of buprenorphine that include the requirement that providers offer or have the ability to refer to psychotherapeutic treatments [71].

    View all citing articles on Scopus
    View full text