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

Opioid Use Disorder Clinical Trial

— NT-814  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02692157
• Other study ID #: IRB#7173
• Secondary ID: U54DA037842
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: February 2016
• Est. completion date: September 20, 2018

Study information

• Verified date: July 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 20, 2018
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder

Intervention

Drug:
• Placebo
Placebo for Neurokinin 1,3 antagonist
• NT-814 50 mg
Neurokinin 1,3 antagonist 50 mg
• NT-814 100 mg
Neurokinin 1,3 antagonist 100 mg
• NT-814 200 mg
Neurokinin 1,3 antagonist 200 mg

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of oxycodone choices	Percentage of drug (versus money) choices in each study arm will be our primary outcome measure.	1 week
Primary	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	Average visual analog scale ratings of "I want heroin"	Average ratings of "I want heroin" in each study arm will be obtained.	1 week