Opioid DependencePhase 1NCT01527994
Aprepitant Effects in Intravenous Heroin Dependence
A Phase 1 study testing Aprepitant in people with Opioid Dependence, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2015
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects ranging in age from 18-55 years who are currently opioid dependent based on meeting DSM-IV criteria for dependence on heroin and who are either treatment or non-treatment seeking individuals.
- Use of intravenous heroin daily for a minimum of 45 days prior to study entry.
- Urine sample (+) for opioids and prior experience with i.v. drug injection.
- Female subjects who are not of childbearing potential, (i.e. post-hysterectomy, or two years post-menopausal) or who are of childbearing potential but will either abstain from heterosexual intercourse and/or practice a medically accepted form of contraception for the study duration.
- Subjects who have experienced significant opioid withdrawal and are familiar with its effects.
- Subjects who are willing to follow the protocol requirements, including methadone and study medication schedules, as evidenced by written informed consent and an ability to read, understand, and complete the study questionnaires.
Who cannot join
- Subjects with any significant current axis-1 psychiatric problems, other than those related to drug abuse and opioid dependence, based on a structured psychiatric interview, SCID or MINI, during the screening process.
- Subjects undergoing active treatment for any illness other than chronic stable medical conditions (Patients with HIV and/or taking anti-viral HIV medication without a manifestation of AIDS symptoms are allowed).
- Subjects with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), 02 saturation measure,12-lead ECG, clinical laboratory tests (CBC, chemistry panel), urine drug screen, alcohol breath test, and urine pregnancy test (for females of childbearing potential only).
- Subjects who have any acute organ dysfunction or serious unstable disease states including symptomatic heart, renal or liver disease, COPD, sleep apnea, or encephalitis.
- Subjects with 02 saturation below 90% at screening.
- Subjects taking any concomitant medications (prescription and over-the-counter therapy) including psychotropic medications for the treatment of current major depression, schizophrenia, or mood disorders, as well as medications contraindicated for use with morphine, naltrexone, aprepitant, or methadone.
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- Subjects who have received any investigational drug or treatment within the thirty (30) days preceding administration of study medication.
- Females who are nursing, pregnant (as confirmed by a positive urine pregnancy test), or at risk of becoming pregnant.
- Subjects allergic or intolerant to morphine, methadone, naloxone, or aprepitant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellevue Hospital Center & the NYU School of Medicine
New York, New York, 10016
About this study
Official title: Clinical Laboratory Evaluations of Aprepitant for the Treatment of Opioid Dependence: Inpatient Test
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.
- Conditions
- Opioid Dependence
- Being tested
- Aprepitant, Placebo pill
- Keywords
- Aprepitant, Intravenous heroin dependence
- 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.
AprepitantDrug
Also called Brand name: Emend
Aprepitant 125 mg oral tablets
Placebo pillDrug
Placebo oral pill- inactive compound
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant 125 mg | Experimental | 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 Receives: Drug: Aprepitant |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (2)
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
Measured: 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
Measured: 45 minutes post challenge drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stephen Ross, MD, Principal investigator, NYU School of Medicine & Bellevue Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527994
- Sponsor's protocol ID
- 09-0457
- Other IDs
- 5R01DA027151-02
- Status last verified
- Aug 2021
- First submitted
- 9 Jan 2012
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Laboratory Evaluations of Aprepitant for the Treatment of Opioid Dependence: Inpatient Test
- ClinicalTrials.gov ID
- NCT01527994
- Acronym / sponsor ID
- 09-0457
- Conditions
- Opioid Dependence
- Keywords
- Aprepitant, Intravenous heroin dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Feb 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant 125 mg | Experimental | Drug: AprepitantDay 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 |
| Placebo | Placebo comparator | Drug: Placebo pillDay 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects ranging in age from 18-55 years who are currently opioid dependent based on meeting DSM-IV criteria for dependence on heroin and who are either treatment or non-treatment seeking individuals.
- Use of intravenous heroin daily for a minimum of 45 days prior to study entry.
- Urine sample (+) for opioids and prior experience with i.v. drug injection.
- Female subjects who are not of childbearing potential, (i.e. post-hysterectomy, or two years post-menopausal) or who are of childbearing potential but will either abstain from heterosexual intercourse and/or practice a medically accepted form of contraception for the study duration.
- Subjects who have experienced significant opioid withdrawal and are familiar with its effects.
Key exclusion criteria (9 listed)
- Subjects with any significant current axis-1 psychiatric problems, other than those related to drug abuse and opioid dependence, based on a structured psychiatric interview, SCID or MINI, during the screening process.
- Subjects undergoing active treatment for any illness other than chronic stable medical conditions (Patients with HIV and/or taking anti-viral HIV medication without a manifestation of AIDS symptoms are allowed).
- Subjects with clinically significant abnormal findings as determined by medical history, physical examination, vital signs (blood pressure, heart rate, and respiration rate), 02 saturation measure,12-lead ECG, clinical laboratory tests (CBC, chemistry panel), urine drug screen, alcohol breath test, and urine pregnancy test (for females of childbearing potential only).
- Subjects who have any acute organ dysfunction or serious unstable disease states including symptomatic heart, renal or liver disease, COPD, sleep apnea, or encephalitis.
- Subjects with 02 saturation below 90% at screening.
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 |
|---|---|---|
| AprepitantAlso: Brand name: EmendAprepitant 125 mg oral tablets | Drug | Aprepitant 125 mg |
| Placebo pillPlacebo oral pill- inactive compound | Drug | Placebo |
Primary outcome
Opioid Withdrawal
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
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
2 secondary outcomes
Opioid Intoxication
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
Time frame: 45 minutes post challenge drug dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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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.
Stephen Ross, MD principal investigator
NYU School of Medicine & Bellevue Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aprepitant in people with Opioid Dependence, run by NYU Langone Health 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 23 Aug 2021. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid Withdrawal (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). 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 23 Aug 2021.