Clinical trial NCT02692157: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
Official title: NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Opioid Use Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-02-25
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of oxycodone choices
timeFrame: 1 week
measure: Average visual analog scale ratings of "I like the choice"
timeFrame: 1 week
Secondary outcomes:
measure: Average visual analog scale ratings of "I want heroin"
timeFrame: 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI and Columbia University
name: Sandra D Comer, PhD
role: PRINCIPAL_INVESTIGATOR
References: