Study Stopped
The study was discontinued by the sponsor. No results to report
NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
NT-814
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2018
CompletedAugust 4, 2020
July 1, 2020
1.5 years
February 18, 2016
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of oxycodone choices
Percentage of drug (versus money) choices in each study arm will be our primary outcome measure.
1 week
Average visual analog scale ratings of "I like the choice"
Average ratings of oxycodone liking in each study arm will be obtained.
1 week
Secondary Outcomes (1)
Average visual analog scale ratings of "I want heroin"
1 week
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo Comparator: Placebo - During this arm, Placebo medication will be administered orally each evening at 8pm.
NT-814 50 mg
ACTIVE COMPARATORActive Comparator: NT-814 50 mg - During this arm, 50 mg NT-814 will be administered orally each evening at 8pm.
NT-814 100 mg
ACTIVE COMPARATORActive Comparator: NT-814 100 mg - During this arm, 100 mg NT-814 will be administered orally each evening at 8pm.
NT-814 200 mg
ACTIVE COMPARATORActive Comparator: NT-814 200 mg - During this arm, 200 mg NT-814 will be administered orally each evening at 8pm.
Interventions
Eligibility Criteria
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)
- lead ECG-based repeated demonstration of QTcF \> 450 msec at screening
- HIV positive
- Any physical disorders that might make participation hazardous
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra D Comer, PhD
NYSPI and Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurobiology
Study Record Dates
First Submitted
February 18, 2016
First Posted
February 25, 2016
Study Start
February 1, 2016
Primary Completion
July 20, 2017
Study Completion
September 20, 2018
Last Updated
August 4, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
Data will be shared via posters and talks at local and national conferences, as well as in publication form. The sharing of raw data will be done by request only, providing that there is a justifiable reason with a clear hypothesis and data analysis plan.