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NCT01527994 · ClinicalTrials.gov registry record · Phase 1
Aprepitant Effects in Intravenous Heroin Dependence
A Phase 1 study of Opioid Dependence, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT01527994 is a Phase 1 study of Opioid Dependence that has completed, run by NYU Langone Health. The registered enrollment target is 64 participants, below the 156-participant average among 29 other Opioid Dependence trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01527994, a Phase 1 study of Opioid Dependence, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Current treatments for opioid addiction would benefit by the addition of a non-opioid based treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1) receptor is involved in opioid reward and withdrawal. This study proposes to study a potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological characteristics of opioid addiction, and what is known of the currently employed treatments, the investigators propose that the therapeutic mechanism of any potential opioid addiction treatment medication must include the ability to reduce opioid withdrawal. This is of particular importance during treatment initiation (eg. detoxification). In addition, for long-term treatment and relapse prevention, it is important to manage drug craving and inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the investigators propose to study aprepitant using human models of opioid withdrawal, craving and acute opioid reward and reinforcement. The investigators will also include a neuro-economics choice procedure paradigm.
Conditions Studied
Interventions
- DRUG Placebo pill
- DRUG Aprepitant
Study Locations (1)
New York
- Bellevue Hospital Center & the NYU School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01527994
The ClinicalTrials.gov registry entry for NCT01527994 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 29 other Opioid Dependence trials with a reported enrollment target (59% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo pill is the first listed.
NCT01527994 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01527994 about?
NCT01527994 is a clinical study titled "Aprepitant Effects in Intravenous Heroin Dependence". Current treatments for opioid addiction would benefit by the addition of a non-opioid based treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1) receptor is involved in opioid reward and withdrawal. This study proposes to study a potential non-opioid treatment, the ...
What is the current status of trial NCT01527994?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2012-01. Estimated completion is 2015-02.
What conditions does trial NCT01527994 study?
This clinical trial studies the following conditions: Opioid Dependence.
What interventions are being tested in trial NCT01527994?
The interventions under investigation include: Placebo pill (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT01527994?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01527994 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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