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Office-Based Treatment of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone
Open accessAbstract
BACKGROUND: Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone has been proposed, but its efficacy and safety have not been well studied. METHODS: We conducted a multicenter, randomized, placebo-controlled trial involving 326 opiate-addicted persons who were assigned to office-based treatment with sublingual tablets consisting of buprenorphine (16 mg) in combination with naloxone (4 mg), buprenorphine alone (16 mg), or placebo given daily for four weeks. The primary outcome measures were the percentage of urine samples negative for opiates and the subjects' self-reported craving for opiates. Safety data were obtained on 461 opiate-addicted persons who participated in an open-label study of buprenorphine and naloxone (at daily doses of up to 24 mg and 6 mg, respectively) and another 11 persons who received this combination only during the trial. RESULTS: The double-blind trial was terminated early because buprenorphine and naloxone in combination and buprenorphine alone were found to have greater efficacy than placebo. The proportion of urine samples that were negative for opiates was greater in the combined-treatment and buprenorphine groups (17.8 percent and 20.7 percent, respectively) than in the placebo group (5.8 percent, P<0.001 for both comparisons); the active-treatment groups also reported less opiate craving (P<0.001 for both comparisons with placebo). Rates of adverse events were similar in the active-treatment and placebo groups. During the open-label phase, the percentage of urine samples negative for opiates ranged from 35.2 percent to 67.4 percent. Results from the open-label follow-up study indicated that the combined treatment was safe and well tolerated. CONCLUSIONS: Buprenorphine and naloxone in combination and buprenorphine alone are safe and reduce the use of opiates and the craving for opiates among opiate-addicted persons who receive these medications in an office-based setting.
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“Treatment of OUD with B/N has been shown to be medically effective (increasing retention in treatment and decreasing use of illicit opioids) and cost-effective.3–8”
From Implementing Group Visits for Opioid Use Disorder: A Case Series (2020) · cites this paper as [5]
In the citing paper
“While participants’ demographic characteristics were similar to those reported in other U.S. and international studies of office-based buprenorphine/naloxone maintenance, our study sample is not necessarily representative of all opioid-dependent patients.13–15”
From Patient Satisfaction with Primary Care Office-Based Buprenorphine/Naloxone Treatment (2007) · cites this paper as [14]
In the citing paper
“In this study, where craving was measured on a 0–100 mm VAS, mean craving more than halved, with a baseline score of 62.4 reducing to 29.8 after 4 weeks of treatment with a sublingual tablet formulation of 16 mg buprenorphine/4 mg naloxone (p < 0.0001, Figure 4 ) [(111) and unpublished data].”
From Craving in Opioid Use Disorder: From Neurobiology to Clinical Practice (2019) · cites this paper as [111]
In the citing paper
“phase III research reports indicate that buprenorphine maintenance is quite safe with equivalent adverse events to methadone and placebo”
From Maintenance Medication for Opiate Addiction: The Foundation of Recovery (2012) · cites this paper as [83]
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“correctional inmates as they leave prison or jail; and (4) the relatively slow dose escalation to therapeutic doses of methadone (Fiellin & O’Connor, 2002; Fudala et al., 2003).”
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Evidenced-Based Treatment of Opioid-Depend ent Patients
van den Brink, W., & Haasen, C. (2006) · Data Archiving and Networked Services (DANS) · Cited by 8
Golovaty, I., & Hagan, S. (2025) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2024.6450 · Cited by 7
Yarborough, B. J. H., Stumbo, S. P., Janoff, S. L., Keast, E. M., Leo, M. C., & Leitz, S. J. (2024) · Drug and Alcohol Dependence Reports · doi:10.1016/j.dadr.2024.100233 · Cited by 7
“It is associated with reduced opioid use, cravings, (Fudala et al., 2003), and reduced mortality (Sordo et al., 2017).”
Bapat, S., Washburn, M., Tata, V., Fleming, M. L., Abughosh, S., Essien, E. J., & Thornton, J. D. (2022) · Substance Use & Misuse · doi:10.1080/10826084.2022.2112226 · Cited by 7
Empirically contrasting urine drug screening‐based opioid use disorder treatment outcome definitions
Brandt, L., Odom, G., Hu, M., Castro, C., Balise, R. R., & the CTN‐0094 Team (2024) · Addiction · doi:10.1111/add.16494 · Cited by 7
Haeny, A. M., Montgomery, L., Burlew, A. K., Campbell, A. N. C., Scodes, J. M., Pavlicová, M., Rotrosen, J., & Nunes, E. V. (2020) · Addictive Behaviors · doi:10.1016/j.addbeh.2020.106514 · Cited by 7
Differences in buprenorphine treatment quality across physician provider specialties
Levin, J. S., Landis, R. K., Sorbero, M., Dick, A. W., Saloner, B. K., & Stein, B. D. (2022) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2022.109510 · Cited by 8
The Availability of Ancillary Counseling in the Practices of Physicians Prescribing Buprenorphine
Barry, D. T., Fazzino, T. L., Necrason, E., Ginn, J., Fiellin, L. E., Fiellin, D. A., & Moore, B. A. (2016) · Journal of Addiction Medicine · doi:10.1097/adm.0000000000000247 · Cited by 7
“…opioid use disorder, physician (J Addict Med 2016;10: 352–356) B uprenorphine is effective in treating opioid use disorder(Ling et al., 1998; Fudala et al., 2003; Fiellin et al., 2006; Schottenfeld et al., 2008) and is considered an essential medication for this indication (World Health…”
BackgroundKapuganti, A., Turner, T., & Thomas, C. J. (2017) · Mental Health Clinician · doi:10.9740/mhc.2017.11.271 · Cited by 7
Wen, H., Xu, S., Zeng, J., Ge, S., Liao, Y., Tang, C., Xiao, S., & Lu, L. (2020) · Trials · doi:10.1186/s13063-020-04930-x · Cited by 7
Update in Addiction Medicine for the Generalist
Gordon, A. J., Kunins, H. V., Rastegar, D. A., Tetrault, J. M., & Walley, A. Y. (2010) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1461-3 · Cited by 7
“These results are comparable to those reported in the landmark clinical trial of office-based buprenorphine, in which the percentage of opiate negative urine rose from 35% to 64% over a year.(53)”
ResultGuo, A. Y., Ma, J. D., Best, B. M., & Atayee, R. S. (2013) · Journal of Analytical Toxicology · doi:10.1093/jat/bkt082 · Cited by 6
“Buprenorphine at low doses is effective in the treatment of acute and chronic pain, whereas at higher doses its use is reserved for the office-based treatment of opioid addiction (6, 7).”
BackgroundLow-dose naloxone provides an abuse-deterrent effect to buprenorphine
Webster, L. R., Smith, M. J., Unal, C., & Finn, A. L. (2015) · Journal of Pain Research · doi:10.2147/jpr.s90780 · Cited by 7
“The inclusion of naloxone in buprenorphine–naloxone (BN) combinations reduces the potential for parenteral abuse while maintaining the benefits of buprenorphine alone.(10,11) Buprenorphine/naloxone buccal film (BBN; Bunavail, BioDelivery Sciences International, Inc.”
Clinical pharmacology of opioids
Rosow, C. E., & Dershwitz, M. (2011) · Cambridge University Press eBooks · doi:10.1017/cbo9780511781933.034 · Cited by 7
Clinical Experience with Fortnightly Buprenorphine/Naloxone versus Buprenorphine in Italy
Amato, P. (2010) · Clinical Drug Investigation · doi:10.2165/11536060-000000000-00000 · Cited by 7
“The successful application of buprenorphine/ naloxone in an outpatient setting in the current study adds to the existing body of literature documenting the use of buprenorphine and buprenorphine/naloxone outside an addiction clinic.([9,11,12,18-25]) In addition, the use of officebased sublingual buprenorphine therapy…”
BackgroundMethodDeflecting a “crisis”: the opioid epidemic in Appalachia as state violence
Pitman, B., & Young, S. T. (2023) · Contemporary Justice Review · doi:10.1080/10282580.2023.2297183 · Cited by 6
“Long-term maintenance programs that include MAT show a reduction in risky behaviors connected to Hepatitis C and HIV, increases in treatment retention and abstinence, and overall decreases in overdoses (FDA, 2019; Fudala et al., 2003; Tsui et al., 2014).”
BackgroundYoung, G. J., Young, L. D., & Noor‐E‐Alam, M. (2024) · Addiction Science & Clinical Practice · doi:10.1186/s13722-024-00516-z · Cited by 6
Course and Treatment of Buprenorphine/Naloxone Withdrawal: An Analysis of Case Reports
Westermeyer, J. J., & McCance‐Katz, E. F. (2012) · American Journal on Addictions · doi:10.1111/j.1521-0391.2012.00259.x · Cited by 6
(2021) · Cambridge University Press eBooks · doi:10.1017/9780511846403 · Cited by 6
Methadone and Buprenorphine in the Perioperative Setting: A Review of the Literature
Foglia, R., Yan, J., & Dizdarevic, A. (2024) · Current Pain and Headache Reports · doi:10.1007/s11916-024-01286-8 · Cited by 6
“A randomized control trial designed for “dose-finding” in the ambulatory surgery population found that intraoperative methadone 0.15 mg/kg was associated with improved pain control and similar side effects to traditional pain con-trol (fentanyl, hydromorphone) [23].”
InfluentialConsiderations on the role of buprenorphine in recovery from heroin addiction from a UK perspective
Nutt, D. (2014) · Journal of Psychopharmacology · doi:10.1177/0269881114555248 · Cited by 6
“Due to buprenorphine’s distinct safety profile, doses can be up-titrated rapidly (up to 8 mg on day 1, increased to 16 mg by day 2) (Fudala et al., 2003).”
BackgroundUse and Misuse of Opioid Replacement Therapies: A Queensland Study
Smirnov, A., & Kemp, R. (2012) · Substance Use & Misuse · doi:10.3109/10826084.2011.629017 · Cited by 6
“Methadone—often considered the gold standard ORT—is provided in a highly regulated environment within the USA and France, with limited take-home dosing (Fudala et al., 2003) due to safety concerns such as diversion, respiratory depression, drug interactions, and its danger in concomitant misuse with benzodiazepines (L…”
BackgroundAntagonist—agonist combinations as therapies for heroin addiction: back to the future?
Nutt, D. (2010) · Journal of Psychopharmacology · doi:10.1177/0269881109356129 · Cited by 6
Maintenance for Opioid Addiction with Buprenorphine and Methadone
Stimmel, B. (2005) · Journal of Addictive Diseases · doi:10.1300/j069v24n03_01 · Cited by 6
Prescription Opioid Injection Among HIV-Positive People Who Inject Drugs in a Canadian Setting
Lake, S., Kerr, T. H., Buxton, J. A., Guillemi, S. A., Parashar, S., Montaner, J. S. G., Wood, E., & Milloy, M. (2016) · AIDS and Behavior · doi:10.1007/s10461-016-1369-y · Cited by 6
“, diacetylmorphine [53], buprenorphine [54], morphine [55]).”
Current Best Practices for Acute and Chronic Management of Patients with Opioid Use Disorder
Peterkin, A. F., Laks, J., & Weinstein, Z. (2021) · Medical Clinics of North America · doi:10.1016/j.mcna.2021.08.009 · Cited by 6
Buprenorphine for Opioid Dependence
Gordon, A. J., & Krumm, M. M. (2013) · Elsevier eBooks · doi:10.1016/b978-0-12-398338-1.00044-0 · Cited by 6
Knudsen, H. K., Lofwall, M. R., Lin, L. A., WALSH, S. L., & Studts, J. L. (2019) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2019.05.022 · Cited by 6
Eficacia y manejo clínico de la buprenorfina
Roncero, C., Sáez‐Francàs, N., Cervelló, X. C., & Casas, M. (2008) · Trastornos Adictivos · doi:10.1016/s1575-0973(08)74549-5 · Cited by 6
Using buprenorphine for outpatient opioid detoxification.
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Influences on advance practice nursing education to prescribe medications for opioid use disorder
Phoenix, B. J., Tierney, M., Chapman, S. A., & Spetz, J. (2023) · Nursing Outlook · doi:10.1016/j.outlook.2023.101963 · Cited by 5
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Buprenorphine: A New Alternative in the Treatment of Opioid Addiction
Tellioğlu, T. (2010) · Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology · doi:10.1080/10177833.2010.11790670 · Cited by 5
“Maintenance doses up to 32 mg/day have been shown to prevent withdrawal symptoms and cravings for opioids (18,21,22), thus reducing illicit opioid use.”
BackgroundAgonist treatment in opioid use: Advances and controversy
Viswanath, B., Chand, P., Benegal, V., & Murthy, P. (2012) · Asian Journal of Psychiatry · doi:10.1016/j.ajp.2012.01.004 · Cited by 5
“, 2001), but equal efficacy with regard to reducing the use of and craving for opiates (Fudala et al., 2003).”
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“For example, primary care–based medication-assisted therapymodels are effective for treating opioid dependence (3).”
Metadata
- Authors
- Fudala, P. J., Bridge, T. P., Herbert, S., Williford, W. O., Chiang, C. N., Jones, K., Collins, J., Raisch, D., Casadonte, P., Goldsmith, R. J., Ling, W., Malkerneker, U., McNicholas, L., Renner, J., Stine, S., & Tusel, D.
- Affiliations
- Veterans Health Administration (US)
- National Institutes of Health (US)
- University of Maryland, Baltimore (US)
- Perry Point VA Medical Center (US)
- University of New Mexico (US)
- VA NY Harbor Healthcare System (US)
- Cincinnati VA Medical Center (US)
- VA West Los Angeles Medical Center (US)
- Edward Hines, Jr. VA Hospital (US)
- University of Pennsylvania (US)
- Boston University (US)
- VA Connecticut Healthcare System (US)
- San Francisco VA Medical Center (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2003-09-04
- Volume
- 349
- Issue
- 10
- Pages
- 949-958
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2147528480
- Cited by
- 577
- References
- 30
- Citations by year
- 2026: 3 · 2025: 11 · 2024: 20 · 2023: 26 · 2022: 22 · 2021: 45 · 2020: 24 · 2019: 20 · 2018: 23 · 2017: 27 · 2016: 24 · 2015: 32 · 2014: 31 · 2013: 36 · 2012: 33
- FWCI
- 24.36
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse (3Y01-DA-30011-04)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- opioid use disorder, buprenorphine, naloxone, sublingual tablets, office-based treatment, opioid craving, urine drug testing, drug safety, opioid use reduction
- MeSH terms
- Administration, Sublingual, Adult, Ambulatory Care, Buprenorphine, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Naloxone, Narcotic Antagonists, Opioid-Related Disorders, Narcotics, Office Visits, Treatment Outcome
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