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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02692157

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

31.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Drug: Placebo Drug: NT-814 50 mg Drug: NT-814 100 mg Drug: NT-814 200 mg	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Jul 20, 2017

Actual Study Completion Date :

Sep 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Percentage of oxycodone choices [1 week]
Percentage of drug (versus money) choices in each study arm will be our primary outcome measure.
Average visual analog scale ratings of "I like the choice" [1 week]
Average ratings of oxycodone liking in each study arm will be obtained.

Secondary Outcome Measures

Average visual analog scale ratings of "I want heroin" [1 week]
Average ratings of "I want heroin" in each study arm will be obtained.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States

Sponsors and Collaborators

New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Sandra D Comer, PhD, NYSPI and Columbia University

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Sandra D. Comer, Professor of Neurobiology, New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT02692157

Other Study ID Numbers:

IRB#7173
U54DA037842

First Posted:

Feb 25, 2016

Last Update Posted:

Aug 4, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Opioid-Related Disorders

Study Results

No Results Posted as of Aug 4, 2020