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

New York State Psychiatric Institute

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Opioid Use Disorder

Treatments: Drug: NT-814 100 mg; Drug: NT-814 50 mg; Drug: NT-814 200 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02692157

IRB#7173

U54DA037842 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 21 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

NT-814 50 mg

Active Comparator group

Description:

Active Comparator: NT-814 50 mg - During this arm, 50 mg NT-814 will be administered orally each evening at 8pm.

Treatment:

Drug: NT-814 50 mg

NT-814 100 mg

Active Comparator group

Description:

Active Comparator: NT-814 100 mg - During this arm, 100 mg NT-814 will be administered orally each evening at 8pm.

Treatment:

Drug: NT-814 100 mg

NT-814 200 mg

Active Comparator group

Description:

Active Comparator: NT-814 200 mg - During this arm, 200 mg NT-814 will be administered orally each evening at 8pm.

Treatment:

Drug: NT-814 200 mg