title: Evaluation of buprenorphine dosage adequacy in opioid receptor agonist substitution therapy for heroin dependence: first use of the BUprenorphine-naloxone Dosage Adequacy eVAluation (BUDAVA) questionnaire.
abstract: BACKGROUND
  The dosing of opioid receptor agonist medications adequately and on an individual basis is crucial in the pharmacotherapy of opioid dependence. Clinical tools that are able to measure dose appropriateness are sorely needed. The recently developed and validated Opiate Dosage Adequacy Scale (ODAS) comprehensively evaluates the main outcomes relevant for methadone dose optimization, namely relapse, cross-tolerance, objective and subjective withdrawal symptoms, craving and overdose. Based on the ODAS, we developed a new assessment tool (BUprenorphine-naloxone Dosage Adequacy eVAluation [BUDAVA]) for evaluating dosage adequacy in patients in treatment with buprenorphine-naloxone.
  
  
  OBJECTIVE
  The main goal of this observational study was to explore whether the BUDAVA questionnaire could be used to assess buprenorphine-based, long-term substitution therapy for heroin addiction.
  
  
  METHODS
  The study included heroin-dependent patients who had been in treatment with buprenorphine-naloxone for at least 3 months. Patients (n = 196) were recruited from 11 drug abuse treatment centres in Italy. Dosage adequacy was assessed with the BUDAVA questionnaire. Patients classified as inadequately treated had their dosage modified. After 1 week, they were again administered the questionnaire to assess the adequacy of the new dosage.
  
  
  RESULTS
  The buprenorphine-naloxone dosage was found to be inadequate in 61 of the 196 patients. In 13 patients, the treatment scored as inadequate only in the subjective withdrawal symptoms item of the questionnaire and therefore no dosage adjustment was made in the 2 weeks that have characterized this work. The remaining 48 inadequately treated patients had their dosage modified (42 dose increases and six dose decreases). After 1 week on the modified dosage, in 24 of these patients the new regimen was found by the assessment with the questionnaire to be adequate.
  
  
  CONCLUSIONS
  These preliminary results suggest that the BUDAVA questionnaire may be useful for guiding buprenorphine-naloxone maintenance dose adjustments in heroin-dependent patients.
authors.affiliation: Servizio Tossicodipendenze, Aversa, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Amore
authors.forename: Filomena
authors.initials: F
authors.lastname: Romano
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Biancolillo
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Lauro
authors.forename: Ciro
authors.initials: C
authors.lastname: Armenante
authors.forename: Anna
authors.initials: A
authors.lastname: Pizzirusso
authors.forename: Salvatore
authors.initials: S
authors.lastname: Del Tufo
authors.forename: Ciro
authors.initials: C
authors.lastname: Ruoppolo
authors.forename: Francesco
authors.initials: F
authors.lastname: Auriemma
authors.forename: Francesco
authors.initials: F
authors.lastname: Cassese
authors.forename: Patrizia
authors.initials: P
authors.lastname: Oliva
authors.forename: Patrizia
authors.initials: P
authors.lastname: Amato
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002047:Buprenorphine / Q000008:administration & dosage*; D000069479:Buprenorphine, Naloxone Drug Combination; D016009:Chi-Square Distribution; D054796:Drug Dosage Calculations; D016903:Drug Monitoring; D006556:Heroin Dependence / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D009270:Naloxone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D058850:Opiate Substitution Treatment; D011237:Predictive Value of Tests; D011957:Receptors, Opioid / Q000819:agonists*; D055502:Secondary Prevention; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D011957:Receptors, Opioid; D009270:Naloxone; D002047:Buprenorphine