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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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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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