Viewing Study NCT00023283



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00023283
Status: COMPLETED
Last Update Posted: 2020-06-29
First Post: 2001-08-30

Brief Title: Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
Sponsor: Yale University
Organization: Yale University

Study Overview

Official Title: Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
Status: COMPLETED
Status Verified Date: 2020-06
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 compare the Standard Medical Management SMM vs SMM enhanced with additional education about addiction and recovery Enhanced Medical Management EMM
Detailed Description: A randomized trial in a hospital primary care clinic for 24 weeks of 168 opioid-dependent subjects maintained on buprenorphine 3xweek and counseled with Standard or Enhanced Medical Management SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation Outcome measures include reduction in opioid use and abstinence from opioids documented by 3xweek urine testing and self report

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
Secondary IDs
Secondary ID Type Domain Link
R01-9803-1 US NIH GrantContract None httpsreporternihgovquickSearchR01DA009803
R01DA009803 NIH None None