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NCT00781898 · ClinicalTrials.gov registry record · Phase 2
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
A Phase 2 study of Opiate Addiction, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
- 1
- Study location
NCT00781898: Completed Phase 2 study of Opiate Addiction, sponsored by University of Pennsylvania.
NCT00781898 is a Phase 2 study of Opiate Addiction that has completed, run by University of Pennsylvania. The registered enrollment target is 308 participants, above the 123-participant average among 5 other Opiate Addiction trials with a reported enrollment target (150% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00781898, a Phase 2 study of Opiate Addiction, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.
Primary Outcome
A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.
Conditions Studied
Interventions
- OTHER Treatment as Usual (TAU)
- DRUG Depot naltrexone
Study Locations (1)
Pennsylvania
- Treatment Research Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2008-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00781898 record still lists
NCT00781898 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, above the 123-participant average among 5 other Opiate Addiction trials with a reported enrollment target (150% higher).
The record links to 1 condition, with Opiate Addiction appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual (TAU) is the first listed.
NCT00781898 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00781898 about?
NCT00781898 is a clinical study titled "Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site". The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Pa...
What is the current status of trial NCT00781898?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2008-06. Estimated completion is 2015-08.
What conditions does trial NCT00781898 study?
This clinical trial studies the following conditions: Opiate Addiction.
What interventions are being tested in trial NCT00781898?
The interventions under investigation include: Treatment as Usual (TAU) (OTHER), Depot naltrexone (DRUG).
Who is sponsoring clinical trial NCT00781898?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00781898 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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