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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: NT-814 50 mg
* Drug: NT-814 100 mg
* Drug: NT-814 200 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |