A Phase 1 interventional study of Aprepitant and Placebo pill in Opioid Dependence, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment
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Among 23 studies in Opioid-Related Disorders by NYU Langone Health — 4 open to participants now, 5 under way, 1 of them phase 3. Opioid-Related Disorders · NYU Langone Health.
Among the 23 studies in Opioid-Related Disorders by NYU Langone Health, this one is the 13th largest by enrollment of the 19 interventional ones that give a count, is the only one that started in 2012, is the only one in phase 1, and was the 2nd registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →4 of the 23 studies in Opioid-Related Disorders by NYU Langone Health are open now, in 1 country. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18–65
NYU Langone Health · Sites in United States
Men only
NYU Langone Health · Sites in United States
Ages 21–75
NYU Langone Health · Sites in United States
Ages 18–85
By country, each count listing its studies:
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 64 is close to the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 217 across the 19 interventional studies, 151 across the 4 observational. Of the 16 that completed or were terminated, 9 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
NYU Langone Health is the lead sponsor of 1,431 studies on the registry; 259 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
4 of the studies in Opioid-Related Disorders by NYU Langone Health that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT06051890NYU Langone HealthAssessing Optimal XRB Initiation Points in Jail | 2026-12-01 |
| NCT04464980NYU Langone HealthOptimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) | 2026-12-31 |
| NCT05722561NYU Langone HealthE-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder | 2027-02-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 23 studies in Opioid-Related Disorders by NYU Langone Health, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Current treatments for opioid addiction would benefit by the addition of a non-opioid based treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1) receptor is involved in opioid reward and withdrawal. This study proposes to study a potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological characteristics of opioid addiction, and what is known of the currently employed treatments, the investigators propose that the therapeutic mechanism of any potential opioid addiction treatment medication must include the ability to reduce opioid withdrawal. This is of particular importance during treatment initiation (eg. detoxification). In addition, for long-term treatment and relapse prevention, it is important to manage drug craving and inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the investigators propose to study aprepitant using human models of opioid withdrawal, craving and acute opioid reward and reinforcement. The investigators will also include a neuro-economics choice procedure paradigm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Day Number Dose Procedure Day 0 Aprepitant 125mg Admitting Medication Treatment Day 1 Aprepitant 125mg Saline-Saline Day 2 Aprepitant 125mg Morphine-Morphine Day 3 Aprepitant 125mg Saline-Morphine Day 4 Aprepitant 125mg Naloxone-Morphine and Discharge
Drug: Aprepitant
Day Number Dose Procedure Day 0 placebo Admitting Medication Treatment Day 1 placebo Saline-Saline Day 2 placebo Morphine-Morphine Day 3 placebo Saline-Morphine Day 4 placebo Naloxone-Morphine and Discharge
Drug: Placebo pill
Aprepitant 125 mg oral tablets
Also known as: Brand name: Emend
Placebo oral pill- inactive compound
Opioid Withdrawal
On the 4 dosing days, opioid withdrawal will be measured using the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opioid Withdrawal Scale (SOWS) at the following time points: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
Time frame: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
Opioid Intoxication
On the 4 dosing days, opioid intoxication will be measured using the Visual Anaglog Scale (VAS)at the following time points: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
Time frame: 30 minutes pre-medication, 150 minutes post medication, 15 minutes post-challenge drug administration, 1 hour post- challenge drug administration, 2 hours post challenge drug administration and 3.5 hours post challenge drug administration
Neuro-economic Choice Procedure
A neuro-economics collaborative team will perform a neuro-economic choice paradigm procedure at 45 minutes post challenge drug dosing to determine the relative proportion and amount of a further dose of drug at 3.5 hours post challenge drug administration versus receipt of a variable amount of money
Time frame: 45 minutes post challenge drug dosing
The record gives a start of Jan 2012, a primary completion of Jun 2014 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aprepitant