NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT02692157

Run by

New York State Psychiatric Institute

People needed

0

Starts

2016-02-01

Expected to finish

2018-09-20

Last updated by the study team

2020-08-04

Who can join

Age: 21 and older, up to 59. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• DSM V criteria for Opioid Use Disorder moderate-severe (304.00)
• Physically healthy
• Able to perform study procedures
• Normal body weight (BMI <30 and >17.5), and total body weight >50 kg (110 lbs)
• Total testosterone in the laboratory normal range (250-1100 ng/dl)
• Current or history of intranasal opioid use.
• Must be willing to use adequate forms of contraception (e.g. condoms in combination with spermicide) for the duration of the study and a specified amount of time after participation.

You may not qualify if…

• On parole or probation
• Elevated liver function (i.e. AST and ALT >2 times the upper limit of normal) or impaired renal function (creatinine within normal limits)
• 12-lead ECG-based repeated demonstration of QTcF > 450 msec at screening
• HIV positive
• Any physical disorders that might make participation hazardous

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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