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NCT00316277 · ClinicalTrials.gov registry record · Phase 3
Prescription Opioid Addiction Treatment Study (POATS)
A Phase 3 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 653
- Enrollment target
NCT00316277: Completed Phase 3 study, sponsored by Mclean Hospital.
NCT00316277 is a Phase 3 study that has completed, run by Mclean Hospital. The registered enrollment target is 653 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316277, a Phase 3 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 653 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.
Primary Outcome
In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.
Interventions
- BEHAVIORAL Standard Medical Management (SMM) of Prescription Opiate Abuse
- BEHAVIORAL Enhanced Medical Management (EMM) of Prescription Opiate Abuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 653 participants |
| Start Date | 2006-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT00316277 record still lists
NCT00316277 is an interventional study that assigns participants to a tested intervention. The registered 653 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Medical Management (SMM) of Prescription Opiate Abuse is the first listed.
NCT00316277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316277 about?
NCT00316277 is a clinical study titled "Prescription Opioid Addiction Treatment Study (POATS)". The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initia...
What is the current status of trial NCT00316277?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 653 participants. The study started on 2006-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00316277?
The interventions under investigation include: Standard Medical Management (SMM) of Prescription Opiate Abuse (BEHAVIORAL), Enhanced Medical Management (EMM) of Prescription Opiate Abuse (BEHAVIORAL).
Who is sponsoring clinical trial NCT00316277?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316277's enrollment target sits among peer trials
653 571st of 2000 higher than 1,430 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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