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Study Status: Withdrawn
Recruit Status: Withdrawn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