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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-09-20

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.

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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.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Placebo Comparator: Placebo - During this arm, Placebo medication will be administered orally each evening at 8pm.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Neurokinin 1,3 antagonist

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.

Group Type ACTIVE_COMPARATOR

NT-814 50 mg

Intervention Type DRUG

Neurokinin 1,3 antagonist 50 mg

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.

Group Type ACTIVE_COMPARATOR

NT-814 100 mg

Intervention Type DRUG

Neurokinin 1,3 antagonist 100 mg

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.

Group Type ACTIVE_COMPARATOR

NT-814 200 mg

Intervention Type DRUG

Neurokinin 1,3 antagonist 200 mg

Interventions

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Placebo

Placebo for Neurokinin 1,3 antagonist

Intervention Type DRUG

NT-814 50 mg

Neurokinin 1,3 antagonist 50 mg

Intervention Type DRUG

NT-814 100 mg

Neurokinin 1,3 antagonist 100 mg

Intervention Type DRUG

NT-814 200 mg

Neurokinin 1,3 antagonist 200 mg

Intervention Type DRUG

Other Intervention Names

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No other names GSK1144814 50 mg GSK1144814 100 mg GSK1144814 200 mg

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes