Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02692157
Status:
WITHDRAWN
Last Update Posted:
2020-08-04
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
Sponsor:
New York State Psychiatric Institute
Organization:
Study Overview
Official Title:
NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was discontinued by the sponsor. No results to report
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NT-814
Brief Summary:
Healthy adult men who abuse opioids and are physically dependent on them will be invited to participate in a study to examine the ability of NT-814, a neurokinin (NK) antagonist at the 1 and 3 receptor subtypes, to alter the abuse liability of oxycodone.
Detailed Description:
After completing the screening process, participants will be scheduled for admission onto the General Clinical Research Unit on 5-South for a 13-week study. During Week 1, participants will be detoxified from opioids. During Week 2 after the detoxification period, participants will be randomized to receive one of four maintenance doses of NT-814. During Weeks 3-4 participants may receive oxycodone during laboratory sessions and will complete a cue exposure session involving presentation of neutral and drug cues. Participants then will have the opportunity to self-administer drug by making clicks on a computer mouse. Weeks 2, 5, 8, and 11 will be medication stabilization weeks following by testing during Weeks 3-4, 6-7, 9-10, and 12-13. At the conclusion of the study, participants will be given an exit interview during which the study will be described. Those who are interested in treatment for their drug use at the end of the study will be offered referrals to studies at our Substance Treatment and Research Service or other treatment providers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U54DA037842 | NIH | None | https://reporter.nih.gov/quic… | View |