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NCT02867124 · ClinicalTrials.gov registry record · Phase 3
Long-acting Naltrexone for Pre-release Prisoners
A Phase 3 study of Opiate Addiction, sponsored by Friends Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT02867124: Completed Phase 3 study of Opiate Addiction, sponsored by Friends Research Institute.
NCT02867124 is a Phase 3 study of Opiate Addiction that has completed, run by Friends Research Institute. The registered enrollment target is 240 participants, above the 137-participant average among 5 other Opiate Addiction trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02867124, a Phase 3 study of Opiate Addiction, has completed, sponsored by Friends Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.
Primary Outcome
XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison
Conditions Studied
Interventions
- DRUG XR-NTX
- OTHER place of residence
- OTHER opioid treatment program
Study Locations (1)
Maryland
- Maryland Department of Public Safety and Correctional Services - Towson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 3 |
What the finished NCT02867124 record still lists
NCT02867124 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 137-participant average among 5 other Opiate Addiction trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Opiate Addiction appearing as the primary indexed condition, and to 3 interventions - of which XR-NTX is the first listed.
NCT02867124 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02867124 about?
NCT02867124 is a clinical study titled "Long-acting Naltrexone for Pre-release Prisoners". This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility ...
What is the current status of trial NCT02867124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2017-01-01. Estimated completion is 2026-01-01.
What conditions does trial NCT02867124 study?
This clinical trial studies the following conditions: Opiate Addiction.
What interventions are being tested in trial NCT02867124?
The interventions under investigation include: XR-NTX (DRUG), place of residence (OTHER), opioid treatment program (OTHER).
Who is sponsoring clinical trial NCT02867124?
This trial is sponsored by Friends Research Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02867124 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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