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

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.

Study Overview

• Status: Withdrawn
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: NT-814 50 mg; Drug: NT-814 100 mg; Drug: NT-814 200 mg

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Comparator: Placebo - During this arm, Placebo medication will be administered orally each evening at 8pm.	Drug: Placebo; Placebo for Neurokinin 1,3 antagonist; Other Names: No other names
Active Comparator: NT-814 50 mg; Active Comparator: NT-814 50 mg - During this arm, 50 mg NT-814 will be administered orally each evening at 8pm.	Drug: NT-814 50 mg; Neurokinin 1,3 antagonist 50 mg; Other Names: GSK1144814 50 mg
Active Comparator: NT-814 100 mg; Active Comparator: NT-814 100 mg - During this arm, 100 mg NT-814 will be administered orally each evening at 8pm.	Drug: NT-814 100 mg; Neurokinin 1,3 antagonist 100 mg; Other Names: GSK1144814 100 mg
Active Comparator: NT-814 200 mg; Active Comparator: NT-814 200 mg - During this arm, 200 mg NT-814 will be administered orally each evening at 8pm.	Drug: NT-814 200 mg; Neurokinin 1,3 antagonist 200 mg; Other Names: GSK1144814 200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average visual analog scale ratings of "I want heroin"	Average ratings of "I want heroin" in each study arm will be obtained.	1 week

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sandra D Comer, PhD, NYSPI and Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB#7173; U54DA037842 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.