Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032968
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2002-04-05
Brief Title:
BuprenorphineNaloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
Sponsor:
University of California Los Angeles
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
BuprenorphineNaloxone Versus Clonidine For Out-patient Opiate Detoxification
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess buprenorphinenaloxone versus clonidine for outpatient opiate detoxification
Detailed Description:
Patients randomized to the BUPNX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine05 mg naloxone tablets andor an 8 mg buprenorphine20 mg naloxone tablets The starting dose on day 1 is 4 mg1 mg BUPNX with an additional 4 mg1 mg if needed escalating in a step-wise manner to 16 mg4 mg BUPNX on day 3 and tapering to 2 mg 05 mg BUPNX by days 12 to 13 Patients randomized to the clonidine arm will receive oral clonidine 005 to 01 mg depending upon weight every 4 to 6 hours for 24 hours not to exceed 06 mg total on day 1 On day 2 a clonidine transdermal patch will be applied 01 mgday7-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 02 mg every 6 hours or 01 mg every 3 hours not to exceed 08 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None