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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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Buprenorphine tapering schedule and illicit opioid use
Ling, W., Hillhouse, M., Domier, C., Doraimani, G., Hunter, J., Thomas, C., Jenkins, J., Hasson, A., Annon, J., Saxon, A., et al. (2009) · Addiction · doi:10.1111/j.1360-0443.2008.02455.x · Cited by 112
“A priori sample size calculation indicated that 240 participants in each group would provide 82% power to detect a 12% difference, assuming 20% opioid-free urine samples in one group [12].”
BackgroundSelf-citationSoyka, M., Kranzler, H. R., van den Brink, W., Krystal, J. H., Möller, H., Kasper, S. F., & The WFSBP Task Force on Treatment, G. F. S. U. D. (2011) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2011.561872 · Cited by 112
“A multi-centre study of 4 weeks of offi ce-based treatment in opioiddependent patients demonstrated a robust effect of buprenorphine with or without naloxone in reducing opiate use and drug craving (Fudala et al. 2003).”
BackgroundSullivan, L. E., Chawarski, M., O’Connor, P. G., Schottenfeld, R. S., & Fiellin, D. A. (2005) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2004.12.008 · Cited by 110
“Similarly, the PCC group was comparable to patients enrolled in a national trial of officebased buprenorphine (Fudala et al., 2003) in terms of age, race, employment status, and treatment history.”
Supply of buprenorphine waivered physicians: The influence of state policies
Stein, B. D., Gordon, A. J., Dick, A. W., Burns, R. M., Pacula, R. L., Farmer, C. M., LESLIE, D. L., & Sorbero, M. (2014) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2014.07.010 · Cited by 110
“…(naltrexone) and opioid agonist (methadone and buprenorphine) medications(Ball & Ross, 1991 ; Fiellin & O’Connor, 2002; Fiellin et al., 2006; Fudala et al., 2003; Johnson et al., 2000; Kakko, Svanborg, Kreek, & Heilig, 2003; Mattick, Kimber, Breen, & Davoli, 2008; National Consensus…”
Buprenorphine–Naloxone Therapy in Pain Management
Chen, K. Y., Chen, L. L., & Mao, J. (2014) · Anesthesiology · doi:10.1097/aln.0000000000000170 · Cited by 113
Richard, E. L., Schalkoff, C. A., Piscalko, H. M., Brook, D., Sibley, A. L., Lancaster, K. E., Miller, W. C., & Go, V. F.-L. (2020) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2020.102704 · Cited by 106
“Successful long-term maintenance MAT reduces overdose and prevalence of HCV and HIV risk behaviors and increases treatment retention and abstinence (FDA, 2019; Krupitsky et al., 2011; Schwartz et al., 2013; Tsui, Evans, Lurn, Hahn & Page, 2014; Fudala et al., 2003; Marsch, 1998).”
BackgroundCompliance with Buprenorphine Medication‐Assisted Treatment and Relapse to Opioid Use
Tkacz, J. P., Severt, J. B., Cacciola, J., & Ruetsch, C. R. (2011) · American Journal on Addictions · doi:10.1111/j.1521-0391.2011.00186.x · Cited by 105
Comer, S. D., Sullivan, M. A., Vosburg, S. K., Manubay, J. M., Amass, L., Cooper, Z. D., Saccone, P. A., & Kleber, H. D. (2010) · Addiction · doi:10.1111/j.1360-0443.2009.02843.x · Cited by 104
“When taken sublingually as prescribed, its therapeutic efficacy and safety are similar to those of buprenorphine alone [15].”
BackgroundTreating Homeless Opioid Dependent Patients with Buprenorphine in an Office-Based Setting
Alford, D. P., LaBelle, C. T., Richardson, J. M., O’Connell, J. J., Hohl, C., Cheng, D. M., & Samet, J. H. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-006-0023-1 · Cited by 104
Buprenorphine and Naloxone Compared With Methadone Treatment in Pregnancy
Wiegand, S. L., Stringer, E. M., Stuebe, A. M., Jones, H. E., Seashore, C. J., & Thorp, J. M. (2015) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000000640 · Cited by 102
Keck, T. M., John, W. S., Czoty, P. W., Nader, M. A., & Newman, A. H. (2015) · Journal of Medicinal Chemistry · doi:10.1021/jm501512b · Cited by 101
Fox, A. D., Maradiaga, J., Weiss, L., Sanchez, J., Starrels, J. L., & Cunningham, C. O. (2015) · Addiction Science & Clinical Practice · doi:10.1186/s13722-014-0023-0 · Cited by 101
“Buprenorphine maintenance treatment (BMT) is an increasingly utilized, efficacious, and safe treatment for opioid use disorder, and it has several features that may enhance acceptability [29-33].”
BackgroundStein, B. D., Pacula, R. L., Gordon, A. J., Burns, R. M., LESLIE, D. L., Sorbero, M., Bauhoff, S., Mandell, T. W., & Dick, A. W. (2015) · Milbank Quarterly · doi:10.1111/1468-0009.12137 · Cited by 100
Venner, K. L., Donovan, D. M., Campbell, A. N. C., Wendt, D. C., Rieckmann, T. R., Radin, S. M., Momper, S. L., & Rosa, C. L. (2018) · Addictive Behaviors · doi:10.1016/j.addbeh.2018.05.017 · Cited by 101
Schottenfeld, R. S., Chawarski, M. C., & Mazlan, M. (2008) · The Lancet · doi:10.1016/s0140-6736(08)60954-x · Cited by 99
Threat response system: Parallel brain processes in pain vis-à-vis fear and anxiety
Elman, I., & Borsook, D. (2018) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2018.00029 · Cited by 100
Rosenthal, R. N., Ling, W. W., Casadonte, P. P., Vocci, F. J., Bailey, G. L., Kampman, K. M., Patkar, A. A., Chavoustie, S. E., Blasey, C. M., Sigmon, S. C., et al. (2013) · Addiction · doi:10.1111/add.12315 · Cited by 98
“Office-based treatment with buprenorphine/naloxone has reported retention rates of 55%) [16].”
Self-citationKnudsen, H. K., Ducharme, L. J., & Roman, P. (2007) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2006.08.013 · Cited by 92
Teruya, C., Schwartz, R. P., Mitchell, S. G., Hasson, A. L., Thomas, C., Buoncristiani, S. H., Hser, Y., Wiest, K. L., Cohen, A. J., Glick, N., et al. (2014) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2014.921743 · Cited by 91
Self-citationBirth and Neonatal Outcomes following Opioid Use in Pregnancy: A Danish Population-Based Study
Nørgaard, M., Nielsson, M. S., & Heide‐Jørgensen, U. (2015) · Substance Abuse Research and Treatment · doi:10.4137/sart.s23547 · Cited by 87
Maglione, M., Raaen, L. B., Chen, C. I., Azhar, G. S., Shahidinia, N., Shen, M., Hernandez, E. J. M., Shanman, R., Newberry, S. J., & Hempel, S. (2018) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2018.03.001 · Cited by 88
Sporer, K. A. (2004) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2003.11.006 · Cited by 87
Patterns of Buprenorphine-Naloxone Treatment for Opioid Use Disorder in a Multistate Population
Saloner, B. K., Daubresse, M., & Alexander, G. C. (2017) · Medical Care · doi:10.1097/mlr.0000000000000727 · Cited by 89
Predictors of early dropout in outpatient buprenorphine/naloxone treatment
Marcovitz, D. E., McHugh, R. K., Volpe, J., Votaw, V. R., & Connery, H. S. (2016) · American Journal on Addictions · doi:10.1111/ajad.12414 · Cited by 92
Jones, H. E., Fischer, G., Heil, S. H., Kaltenbach, K. A., Martin, P., Coyle, M. G., Selby, P. L., Stine, S. M., O’Grady, K. E., & Arria, A. M. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.04036.x · Cited by 86
“Although Suboxone (buprenorphine + naloxone) was created to reduce the abuse liability of Subutex (buprenorphine alone) [14], Subutex was selected for this trial for several reasons.”
BackgroundSelf-citationFiellin, D., Weiss, L., Botsko, M., Egan, J. E., Altice, F., Bazerman, L., Chaudhry, A., Cunningham, C., Gourevitch, M., Lum, P. J., et al. (2011) · Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e3182097537 · Cited by 88
“Most patients received doses of buprenorphine/naloxone and office visits at a frequency that is consistent with prior research and federal guidelines.(15,16,20) Urine toxicology monitoring was less frequent, however, than what is recommended by existing guidelines on the use of buprenorphine/naloxone in the treatment…”
ResultThe Burden of the Nonmedical Use of Prescription Opioid Analgesics
Gilson, A. M., & Kreis, P. G. (2009) · Pain Medicine · doi:10.1111/j.1526-4637.2009.00668.x · Cited by 84
Hood, J. E., Banta‐Green, C. J., Duchin, J. S., Breuner, J., Dell, W., Finegood, B., Glick, S. N., Hamblin, M., Holcomb, S., Mosse, D., et al. (2019) · Substance Abuse · doi:10.1080/08897077.2019.1635557 · Cited by 82
Marsch, L. A., Bickel, W. K., Badger, G. J., & Jacobs, E. A. (2004) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2004.08.011 · Cited by 81
“As a result, buprenorphine may be provided to opioid-dependent patients by qualified physicians in both Opiate Treatment Clinics and office-based settings (Drug Addiction Treatment Act of 2000;Fiellin and O’Connor, 2002; Fudala et al., 2003).”
Perioperative Management of Buprenorphine: Solving the Conundrum
Quaye, A., & Zhang, Y. (2018) · Pain Medicine · doi:10.1093/pm/pny217 · Cited by 83
Bell, J. R., Shanahan, M., Mutch, C., Rea, F., Ryan, A., Batey, R. G., Dunlop, A. J., & WINSTOCK, A. R. (2007) · Addiction · doi:10.1111/j.1360-0443.2007.01979.x · Cited by 79
Comorbid Posttraumatic Stress Disorder and Opiate Addiction: A Literature Review
Fareed, A., Eilender, P., Haber, M. J., Bremner, J. D., Whitfield, N., & Drexler, K. P. G. (2013) · Journal of Addictive Diseases · doi:10.1080/10550887.2013.795467 · Cited by 78
Merlo, L. J., Campbell, M. D., Skipper, G. E., Shea, C. L., & DuPont, R. L. (2016) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2016.02.004 · Cited by 77
Combating opiate dependence: a comparison among the available pharmacological options
Gonzalez, G. M., Oliveto, A. H., & Kosten, T. R. (2004) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.5.4.713 · Cited by 79
“Buprenorphine plus naloxone (Suboxone) is now available in the US for office-based practice [63,129,130] and this approach is expected to increase the access to treatment by transferring stable methadone maintained patients out of methadone clinics and opening methadone treatment slots for more complex patients, by in…”
BackgroundPatterns and Quality of Buprenorphine Opioid Agonist Treatment in a Large Medicaid Program
Gordon, A. J., Lo-Ciganic, W.-H., Cochran, G., Gellad, W. F., Cathers, T., Kelley, D., & Donohue, J. M. (2015) · Journal of Addiction Medicine · doi:10.1097/adm.0000000000000164 · Cited by 76
“…using buprenorphine (eitherbuprenorphine monotherapy or buprenorphine/naloxone pharmacotherapy) is an evidence-based, cost effective treatment for opioid use disorder (OUD) (Fudala et al., 2003; Fiellin et al., 2006; Barnett, 2009; Jones et al., 2009; Mattick et al., 2014; Volkow et al., 2014).”
BackgroundMethodPredictors of outcome in LAAM, buprenorphine, and methadone treatment for opioid dependence.
Marsch, L. A., Stephens, M. A. C., Mudric, T., Strain, E. C., Bigelow, G. E., & Johnson, R. E. (2005) · Experimental and Clinical Psychopharmacology · doi:10.1037/1064-1297.13.4.293 · Cited by 75
“One hope regarding the FDA’s recent approval of buprenorphine for use in medical office– based practice in the U.S. is that this new medication and new treatment context will attract new and possibly different types of opioid-dependent patients into treatment (Fudala et al., 2003).”
BackgroundPatient Satisfaction with Primary Care Office-Based Buprenorphine/Naloxone Treatment
Barry, D. T., Moore, B. A., Pantalon, M. V., Chawarski, M. C., Sullivan, L. E., O’Connor, P. G., Schottenfeld, R. S., & Fiellin, D. A. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-006-0050-y · Cited by 74
Bailey, G. L., Herman, D. S., & Stein, M. D. (2013) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2013.04.002 · Cited by 74
“Despite the significant clinical and empirical support for the use of three FDA approved medications (Fiellin et al., 2008; Fudala et al., 2003; Kreek et al., 2010; Krupitsky et al., 2011; Mattick et al., 2008; Mattick et al., 2009), most patients are not prescribed any medication at the time of…”
Background
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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