Opioid Use DisorderPhase 1/2NT-814NCT02692157
NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
A Phase 1/2 study testing NT-814 50 mg, NT-814 100 mg and NT-814 200 mg in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- NT-814 50 mg, NT-814 100 mg and NT-814 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 20 Sep 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Placebo, NT-814 50 mg, NT-814 100 mg, NT-814 200 mg
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called No other names
Placebo for Neurokinin 1,3 antagonist
NT-814 50 mgDrug
Also called GSK1144814 50 mg
Neurokinin 1,3 antagonist 50 mg
NT-814 100 mgDrug
Also called GSK1144814 100 mg
Neurokinin 1,3 antagonist 100 mg
NT-814 200 mgDrug
Also called GSK1144814 200 mg
Neurokinin 1,3 antagonist 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Comparator: Placebo - During this arm, Placebo medication will be administered orally each evening at 8pm. Receives: Drug: Placebo |
| NT-814 50 mg | Active comparator | Active Comparator: NT-814 50 mg - During this arm, 50 mg NT-814 will be administered orally each evening at 8pm. Receives: Drug: NT-814 50 mg |
| NT-814 100 mg | Active comparator | Active Comparator: NT-814 100 mg - During this arm, 100 mg NT-814 will be administered orally each evening at 8pm. Receives: Drug: NT-814 100 mg |
| NT-814 200 mg | Active comparator | Active Comparator: NT-814 200 mg - During this arm, 200 mg NT-814 will be administered orally each evening at 8pm. Receives: Drug: NT-814 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of oxycodone choices
Percentage of drug (versus money) choices in each study arm will be our primary outcome measure.
Measured: 1 week
Average visual analog scale ratings of "I like the choice"
Average ratings of oxycodone liking in each study arm will be obtained.
Measured: 1 week
Secondary outcomes (1)
Average visual analog scale ratings of "I want heroin"
Average ratings of "I want heroin" in each study arm will be obtained.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion20 Jul 2017
- Study completion20 Sep 2018
Why it stopped: The study was discontinued by the sponsor. No results to report
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sandra D. Comer, New York State Psychiatric Institute
- Investigators
- Sandra D Comer, PhD, Principal investigator, NYSPI and Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692157
- Sponsor's protocol ID
- IRB#7173
- Other IDs
- U54DA037842
- Acronym
- NT-814
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2016
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared via posters and talks at local and national conferences, as well as in publication form. The sharing of raw data will be done by request only, providing that there is a justifiable reason with a clear hypothesis and data analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-814: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in an Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT02692157
- Acronym / sponsor ID
- NT-814 / IRB#7173
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was discontinued by the sponsor. No results to report
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2016 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: Placebo - During this arm, Placebo medication will be administered orally each evening at 8pm. |
| NT-814 50 mg | Active comparator | Drug: NT-814 50 mgActive Comparator: NT-814 50 mg - During this arm, 50 mg NT-814 will be administered orally each evening at 8pm. |
| NT-814 100 mg | Active comparator | Drug: NT-814 100 mgActive Comparator: NT-814 100 mg - During this arm, 100 mg NT-814 will be administered orally each evening at 8pm. |
| NT-814 200 mg | Active comparator | Drug: NT-814 200 mgActive Comparator: NT-814 200 mg - During this arm, 200 mg NT-814 will be administered orally each evening at 8pm. |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: No other namesPlacebo for Neurokinin 1,3 antagonist | Drug | Placebo |
| NT-814 50 mgAlso: GSK1144814 50 mgNeurokinin 1,3 antagonist 50 mg | Drug | NT-814 50 mg |
| NT-814 100 mgAlso: GSK1144814 100 mgNeurokinin 1,3 antagonist 100 mg | Drug | NT-814 100 mg |
| NT-814 200 mgAlso: GSK1144814 200 mgNeurokinin 1,3 antagonist 200 mg | Drug | NT-814 200 mg |
Primary outcome
Percentage of oxycodone choices
Time frame: 1 week
Percentage of drug (versus money) choices in each study arm will be our primary outcome measure.
Average visual analog scale ratings of "I like the choice"
Time frame: 1 week
Average ratings of oxycodone liking in each study arm will be obtained.
1 secondary outcome
Average visual analog scale ratings of "I want heroin"
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Yes. Data will be shared via posters and talks at local and national conferences, as well as in publication form. The sharing of raw data will be done by request only, providing that there is a justifiable reason with a clear hypothesis and data analysis plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra D Comer, PhD principal investigator
NYSPI and Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NT-814 50 mg, NT-814 100 mg and NT-814 200 mg in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of oxycodone choices (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.