Opioid Use DisorderPhase 2NCT03389750

A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.

A Phase 2 study testing Intravenous Challenge Drug in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 55 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: Intravenous Challenge Drug
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 15 Mar 2018to 28 Jun 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Able to understand and provide signed and dated written consent.
Self-reported opioid use for nontherapeutic purposes on at least 21 days in the 30 days prior to screening, physical dependence on opioids, recent intravenous opioid use, and meeting DSM 5 criteria for moderate-severe opioid use disorder.
Positive urine drug screen for opioids (those who are in a methadone or buprenorphine treatment program are ineligible; physical dependence on street methadone or buprenorphine are also exclusionary so participants must produce at least one methadone- or buprenorphine-negative urine during screening).
≥ 21 and ≤ 55 years of age.
Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 and weight ≥ 50 kg (110 pounds).
Otherwise healthy as determined by the investigator.

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Demonstrate understanding how to complete the self-administration tasks and VAS Questionnaire.
Women of childbearing potential must not be pregnant or breastfeeding at screening.
Willing and able to comply with all testing requirements defined in the protocol.
participation in the Study Treatment Phase:
During the Study Qualification Phase, on the bipolar 100--mm Drug Liking VAS, the subject must provide Emax ≥ 40 mm and < 60 mm following placebo and, following morphine 56 mg/70 kg, i.v., Emax ≥ 60 mm and ≥ 15 mm closer to "Strong Liking" than the Emax to placebo.
In the judgment of the investigator, the subject is able to tolerate the i.v., opioids administered in the study, including the ability to complete most pharmacodynamics assessments administered post--dose.
In the judgment of the study staff, the subject's general behavior during the Study Qualification Phase suggests the ability to successfully complete the Study Treatment Phase.

Who cannot join

History of a medical or psychiatric disorder that would prevent successful completion of the study.
Current DSM-5 diagnosis of substance use disorders requiring medical management other than OUD.
Suicidal ideation or intent with or without a plan at Screening or within 6 months prior to Screening (i.e., answering "Yes" to questions 4 and/or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale).
Currently seeking or participating in treatment for substance use disorder.
Physically dependent on drugs of abuse (other than opioids, nicotine, or caffeine) or alcohol.
Medically important deviation from normal limits on physical examination, vital signs, screening laboratory tests, or 12--lead ECG.

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Significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic disorder.
Any surgical, or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test drug.
Family history of long QT syndrome and/or unexpected sudden cardiac death or is known to have QTc > 500 ms at screening.
Used an investigational agent within 30 days or 5 therapeutic half-lives of that agent, whichever is longer, prior to the first dose of study drug.
Hypersensitivity to opioids or any drug intended for use in this study.
Acute gastrointestinal symptoms (e.g., nausea, vomiting, fever, or Diarrhea unrelated to opioid withdrawal) ≤ 7 days before Day 1.
Any of the following values for laboratory tests at Screening:
A positive pregnancy test in women of childbearing potential.
Hemoglobin < 11 g/dL in males and < 10 gm/dL in females.
Neutrophil count < 1.0 × 109/L.
Platelet count < 75 × 109/L.
Creatinine clearance < 50 ml/min per modified Cockcroft-Gault equation.
Aspartate aminotransferase or alanine aminotransferase > 3.0x upper limit of normal.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kentucky
Lexington, Kentucky, 40508
New York State Psychiatric Institute in the Division on Substance Use Disorders
New York, New York, 10032

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder

Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a potent mu-opioid pain medication. However, little is known about its abuse potential relative to other mu-opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and hydromorphone) among physically dependent opioid abusers.

Read the detailed description

Significant public health concerns have arisen from the misuse of oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER. However, little is known about its abuse potential relative to other mu opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone and hydromorphone). Participants who are physically dependent on opioids and who meet DSM 5 criteria for Opioid Use Disorder will complete the study across 2 sites, New York State Psychiatric Institute (NYSPI) and the University of Kentucky; a total of 6 additional participants across 2 sites will complete a pilot phase of the study in order to establish comparable opioid dose-response functions based on subjective ratings of Drug Liking. All participants will reside in clinical inpatient units for the duration of the studies (both the 8- to 9-week main and 4- to 5-week pilot studies; please note that the pilot study is identical in design to the first 4-5 weeks of the main study). The study design is based on the 2017 FDA Assessment of Abuse Potential of Drugs: Guidance for Industry [Center for Drug Evaluation and Research (CDER), 2017], which suggests the use of a double-blind, positive- and placebo-controlled design that includes a qualification phase and VAS measure of Drug Liking. The proposed study also examines the reinforcing effects of oxymorphone and other mu opioid agonists using two different drug self-administration procedures, namely Drug versus Money and Drug versus Drug choice procedures.

Conditions: Opioid Use Disorder
Being tested: Intravenous Challenge Drug
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.

Intravenous Challenge DrugDrug
Also called Oxycodone, Oxymorphone, Hydromorphone, or Placebo
Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).

Study groups in NCT03389750
Study group	Role	What they receive
Intravenous Challenge Drug: Oxymorphone	Active comparator	Intravenous (IV) Dose Range: 1.8, 3.2, 5.6, 10 mg/70kg of the participant's body weight Receives: Drug: Intravenous Challenge Drug
Intravenous Challenge Drug: Oxycodone	Active comparator	IV Dose Range: 10, 18, 32, 56 mg/70kg of the participant's body weight Receives: Drug: Intravenous Challenge Drug
Intravenous Challenge Drug: Hydromorphone	Active comparator	IV Dose Range: 3.2, 5.6, 10, 18 mg/70kg of the participant's body weight Receives: Drug: Intravenous Challenge Drug
Intravenous Challenge Drug: Placebo	Placebo comparator	IV saline Receives: Drug: Intravenous Challenge Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive Subjective Drug Effects (i.e., Drug "Liking").
The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug "liking" rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect.
Measured: Throughout study enrollment period (8-9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201828 Jun 2023

First posted4 Jan 2018
Study start15 Mar 2018
Primary completion15 Jun 2022
Study completion28 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Intravenous Challenge Drug
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03389750
Sponsor's protocol ID: 7565
Status last verified: Aug 2023
First submitted: 19 Dec 2017
Last updated: 7 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder
ClinicalTrials.gov ID: NCT03389750
Acronym / sponsor ID: 7565
Conditions: Opioid Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: University of Kentucky
Study start: 15 Mar 2018 (actual)
Primary completion: 15 Jun 2022 (actual)
Study completion: 28 Jun 2023 (actual)
First posted: 4 Jan 2018 (actual)
Results: Posted 7 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4
Model description: Intravenous Challenge Drug

Arm	Type	Receives
Intravenous Challenge Drug: Oxymorphone	Active comparator	Drug: Intravenous Challenge DrugIntravenous (IV) Dose Range: 1.8, 3.2, 5.6, 10 mg/70kg of the participant's body weight
Intravenous Challenge Drug: Oxycodone	Active comparator	Drug: Intravenous Challenge DrugIV Dose Range: 10, 18, 32, 56 mg/70kg of the participant's body weight
Intravenous Challenge Drug: Hydromorphone	Active comparator	Drug: Intravenous Challenge DrugIV Dose Range: 3.2, 5.6, 10, 18 mg/70kg of the participant's body weight
Intravenous Challenge Drug: Placebo	Placebo comparator	Drug: Intravenous Challenge DrugIV saline

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Able to understand and provide signed and dated written consent.
Self-reported opioid use for nontherapeutic purposes on at least 21 days in the 30 days prior to screening, physical dependence on opioids, recent intravenous opioid use, and meeting DSM 5 criteria for moderate-severe opioid use disorder.
Positive urine drug screen for opioids (those who are in a methadone or buprenorphine treatment program are ineligible; physical dependence on street methadone or buprenorphine are also exclusionary so participants must produce at least one methadone- or buprenorphine-negative urine during screening).
≥ 21 and ≤ 55 years of age.
Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 and weight ≥ 50 kg (110 pounds).

Key exclusion criteria (19 listed)

History of a medical or psychiatric disorder that would prevent successful completion of the study.
Current DSM-5 diagnosis of substance use disorders requiring medical management other than OUD.
Suicidal ideation or intent with or without a plan at Screening or within 6 months prior to Screening (i.e., answering "Yes" to questions 4 and/or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale).
Currently seeking or participating in treatment for substance use disorder.
Physically dependent on drugs of abuse (other than opioids, nicotine, or caffeine) or alcohol.

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
Intravenous Challenge DrugAlso: Oxycodone, Oxymorphone, Hydromorphone, or PlaceboIntravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).	Drug	Intravenous Challenge Drug: Hydromorphone, Intravenous Challenge Drug: Oxycodone, Intravenous Challenge Drug: Oxymorphone, Intravenous Challenge Drug: Placebo

Primary outcome

Positive Subjective Drug Effects (i.e., Drug "Liking").
Time frame: Throughout study enrollment period (8-9 weeks)
The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug "liking" rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect.

Results and safety

Results posted to the registry on 7 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Challenge Drug	16	8

Primary outcome: Positive Subjective Drug Effects (i.e., Drug "Liking").

Time frame: Throughout study enrollment period (8-9 weeks). Mean (Standard Error). Unit: units on a scale

Measure	IV Placebo n = 8	IV Oxymorphone 1.8 mg n = 8	IV Oxymorphone 3.2 mg n = 8	IV Oxymorphone 5.6 mg n = 8	IV Oxymorphone 10 mg n = 8	IV Hydromorphone 3.2 mg n = 8	IV Hydromorphone 5.6 mg n = 8	IV Hydromorphone 10 mg n = 8	IV Hydromorphone 18 mg n = 8	IV Oxycodone 10 mg n = 8	IV Oxycodone 18 mg n = 8	IV Oxycodone 32 mg n = 8	IV Oxycodone 56 mg n = 8
Value	52.1 (1.0)	57.5 (2.8)	71.8 (5.2)	71.5 (6.1)	84 (4.9)	66.3 (3.8)	71.3 (4.9)	84.3 (4.8)	79.6 (5.4)	59.5 (3.9)	63.3 (3.9)	70.3 (4.4)	79.1 (5.5)

IV Placebo vs IV Oxymorphone 1.8 mg vs IV Oxymorphone 3.2 mg vs IV Oxymorphone 5.6 mg vs IV Oxymorphone 10 mg vs IV Hydromorphone 3.2 mg vs IV Hydromorphone 5.6 mg vs IV Hydromorphone 10 mg vs IV Hydromorphone 18 mg vs IV Oxycodone 10 mg vs IV Oxycodone 18 mg vs IV Oxycodone 32 mg vs IV Oxycodone 56 mg: p = .0001, ANOVA

Population analysed: The most robust self-reported drug "Liking" across the various dose of each IV drug (Scale: 0-100). These data are reported only for study completers (i.e., those individuals who experienced all 13 drug \& dose drug conditions). Higher values indicate a greater drug effect.

Adverse events

Time frame: Throughout the 8-week inpatient period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Challenge Drug: Placebo 0 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxymorphone 1.8 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxymorphone 3.2 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxymorphone 5.6 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxymorphone 10 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Hydromorphone 3.2 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Hydromorphone 5.6 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Hydromorphone 10 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Hydromorphone 18 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxycodone 10 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxycodone 18 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxycodone 32 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16
IV Challenge Drug: Oxycodone 56 mg	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Opioid Use Disorder

Not yet recruiting
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Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
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Not yet recruiting
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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

New York State Psychiatric Institute / Columbia University Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous Challenge Drug in people with Opioid Use Disorder, run by New York State Psychiatric Institute at 2 sites 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 13 inclusion and 19 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Positive Subjective Drug Effects (i.e., Drug "Liking"). (time frame: Throughout study enrollment period (8-9 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389750.

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 7 Sep 2023.