Clinical Trial: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)

Brief Summary: The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Detailed Summary: Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
Sponsor: University of Colorado, Denver

Current Primary Outcome:

  • Drug use
  • Retention
  • Subjective dose estimate
  • Observed withdrawal rating
  • Opioid agonist rating
  • Opioid antagonist rating
  • Pupil diameter
  • Compliance
  • Analog rating scale for drug effects
  • Drug effect characteristics
  • Dose order estimate-nurse
  • Dose order estimate-client


Original Primary Outcome:

  • Analog rating scale for drug effects
  • Drug effect characteristics
  • Dose order estimate-nurse
  • Dose order estimate-client
  • Compliance
  • Drug use
  • Retention
  • Subjective dose estimate
  • Observed withdrawal rating
  • Opioid agonist rating
  • Opioid antagonist rating
  • Pupil diameter


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: September 20, 1999
Date Started: April 1997
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017