Buprenorphine treatment of opioid dependence: clinical trial of daily versus alternate-day dosing

Rolley E. Johnson, Thomas Eissenberg, Maxine L. Stitzer, Eric C. Strain, Ira A. Liebson, George E. Bigelow

Research output: Contribution to journalArticle

Abstract

Buprenorphine, a mu-opioid partial agonist, has demonstrated efficacy for the treatment of opioid dependence comparable to that of methadone. The clinical utility of buprenorphine would be enhanced if it could be dosed on a less than daily basis. The current study is a parallel-group outpatient clinical trial of daily versus alternate-day dosing with 8 mg sublingual (s.l.) buprenorphine. Participants were randomly assigned to daily (n = 51) or alternate-day (n = 48) schedules of active medication administration for an 11-week double-blind trial. Patients assigned to alternate-day buprenorphine received placebo every other day. Primary outcome measures were retention in treatment and urine specimens positive for opiates. Clinic attendance, dose adequacy ratings, withdrawal symptomatology, and urine specimens positive for cocaine were secondary outcome measures. Neither endpoint analysis with the intent-to-treat sample nor time course analysis with treatment completers revealed any statistically significant differences between the dosing schedules on any outcome measure. Examination of 95% confidence intervals suggested a non-significant trend for the daily dosing schedule to have superior clinical efficacy at the dose tested. Nevertheless, these results are generally consistent with previous studies of less than daily dosing with buprenorphine and support the conclusion that an alternate-day dosing schedule can be effective in and acceptable to a substantial portion of patients.

Original languageEnglish (US)
Pages (from-to)27-35
Number of pages9
JournalDrug and alcohol dependence
Volume40
Issue number1
DOIs
StatePublished - Nov 1995

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Keywords

  • Alternate-day dosing
  • Buprenorphine
  • Clinical trial
  • Drug abuse
  • Efficacy
  • Opioid dependence

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)

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