title: Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films.
abstract: 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.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland, USA. estrain1@jhmi.edu
authors.forename: E C
authors.initials: EC
authors.lastname: Strain
authors.forename: J A
authors.initials: JA
authors.lastname: Harrison
authors.forename: G E
authors.initials: GE
authors.lastname: Bigelow
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D000069479:Buprenorphine, Naloxone Drug Combination; D004311:Double-Blind Method; D017277:Drug Approval; D004349:Drug Packaging; D005260:Female; D006801:Humans; D008297:Male; D008509:Medication Systems; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D058850:Opiate Substitution Treatment / Q000379:methods*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D012995:Solubility; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D013607:Tablets; D013649:Taste; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine