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NCT00315341 · ClinicalTrials.gov registry record · Phase 4
Starting Treatment With Agonist Replacement Therapies (START)
A Phase 4 study of Opiate-Related Disorders, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,269
- Enrollment target
- 9
- Study locations
NCT00315341: Completed Phase 4 study of Opiate-Related Disorders, sponsored by University of California, Los Angeles.
NCT00315341 is a Phase 4 study of Opiate-Related Disorders that has completed, run by University of California, Los Angeles. The registered enrollment target is 1,269 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (145% higher). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315341, a Phase 4 study of Opiate-Related Disorders, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,269 participants
- Enrollment target
- 9
- Study locations
Study Summary
The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.
Primary Outcome
Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner: A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN C: Either ALT or AST started \> 2 x ULN, decreased (both ALT and AST) to \< 2 x ULN, an
Conditions Studied
Interventions
- DRUG Methadone
- DRUG Buprenorphine/naloxone
Study Locations (9)
California
- Matrix Institute - Los Angeles
- Bi-Valley Medical Clinic INC. - Sacramento
- BAART; Turk Street Clinic - San Francisco
Connecticut
- Hartford Dispensary - Hartford
- CT Counseling Centers - Waterbury
New York
- Addiction Research & Treatment Corp - Brooklyn
Oregon
- CODA-Research - Portland
Pennsylvania
- NET Steps - Philadelphia
Washington
- Evergreen Treatment Services - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,269 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 4 |
What the finished NCT00315341 record still lists
NCT00315341 is an interventional study that assigns participants to a tested intervention. Its 1,269 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (145% higher).
The record links to 1 condition, with Opiate-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which Methadone is the first listed.
NCT00315341 lists 9 locations in 6 states (California, Connecticut, New York).
Frequently Asked Questions
What is clinical trial NCT00315341 about?
NCT00315341 is a clinical study titled "Starting Treatment With Agonist Replacement Therapies (START)". The Food and Drug Administration (FDA) has requested a study comparing buprenorphine/naloxone (BUP/NX) and methadone (MET) on indices of hepatic safety.
What is the current status of trial NCT00315341?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,269 participants. The study started on 2006-04. Estimated completion is 2010-08.
What conditions does trial NCT00315341 study?
This clinical trial studies the following conditions: Opiate-Related Disorders.
What interventions are being tested in trial NCT00315341?
The interventions under investigation include: Methadone (DRUG), Buprenorphine/naloxone (DRUG).
Who is sponsoring clinical trial NCT00315341?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00315341 being conducted?
This trial has 9 study locations across California, Connecticut, New York, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opiate-Related Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00315341's enrollment target sits among peer trials
1,269 61st of 2000 higher than 1,940 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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