Clinical Trial: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification

Brief Summary: The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.

Detailed Summary: Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.
Sponsor: University of California, Los Angeles

Current Primary Outcome:

  • Drug use
  • Degree of drug craving
  • Adverse events
  • Drug craving
  • Decreased frequency of HIV related behavior
  • Adverse effect measures


Original Primary Outcome:

  • Adverse effect measures
  • Adverse events
  • Drug craving
  • Decreased frequency of HIV related behavior
  • Degree of drug craving
  • Drug use


Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute on Drug Abuse (NIDA)

Dates:
Date Received: April 5, 2002
Date Started: February 2001
Date Completion:
Last Updated: January 11, 2017
Last Verified: April 2010