Starting Treatment With Agonist Replacement Therapies (START)

Opiate-related Disorders Clinical Trial

Official title: Starting Treatment With Agonist Replacement Therapies (START)

Status Active, not recruiting

Clinical Trial Summary

The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.

Clinical Trial Description

This is a randomized, open-label, multi-center, Phase 4 study to assess the changes in liver enzymes related to treatment with buprenorphine/naloxone (BUP/NX) and methadone (MET) in participants entering opioid agonist treatment. Randomization will be stratified, within site, according to normal versus abnormal screening liver function tests. Participants meeting entry criteria will be dosed for 24 weeks during the active phase of the study with assessment of liver function at weeks 1, 2, 4, 8, 12, 16, 20, 24 and with follow-up assessments at week 32. Clinicians will be encouraged to treat with adequate doses of BUP/NX and MET. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate-related Disorders

• NCT number: NCT00315341
• Study type: Interventional
• Source: National Institute on Drug Abuse (NIDA)
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 2006
• Completion date: June 2010