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

• Status: Withdrawn
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Oxycodone

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