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Induction of Opioid‐Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone Soluble‐Films
Author(s) -
Strain EC,
Harrison JA,
Bigelow GE
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.352
Subject(s) - buprenorphine , (+) naloxone , opioid , morphine , medicine , pharmacology , hydromorphone , opiate , anesthesia , receptor
A sublingual soluble‐film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit‐dose, child‐resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid‐dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone‐induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty‐four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction. Clinical Pharmacology & Therapeutics (2011) 89 3, 443–449. doi: 10.1038/clpt.2010.352