Opioid OverdosePhase 4COINEDNCT05808881
Clinical Outcomes From Nalmefene
A Phase 4 study testing Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection in people with Opioid Overdose, run by Purdue Pharma LP.
Trial summary
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to May 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presumed or known opioid overdose in community settings.
- Experiencing clinically significant respiratory depression based on appropriate medical judgement.
- Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
- Pre-hospital naloxone administration is allowed.
Who cannot join
- Patient age known or estimated to be less than 18 years.
- Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
- Cardiac arrest, secondary to opioid intoxication.
- Arrested, jailed, or imprisoned patients.
- Inappropriate for the study per judgement of research team.
About this study
Official title: Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
- Conditions
- Opioid Overdose
- Being tested
- Nalmefene Hydrochloride Injection, Naloxone Hydrochloride Injection
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene Hydrochloride InjectionDrug
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Naloxone Hydrochloride InjectionDrug
Also called Narcan
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
| Study group | Role | What they receive |
|---|---|---|
| Nalmefene | Experimental | Nalmefene hydrochloride (HCl) injection Receives: Drug: Nalmefene Hydrochloride Injection |
| Naloxone | Active comparator | Naloxone hydrochloride (HCl) injection Receives: Drug: Naloxone Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of Respiratory Depression
Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg
and/or
≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.
Measured: Up to 3 hours
Secondary outcomes (8)
Time to Reversal from administration of opioid antagonist
Measured: Up to 3 hours
Recurrence of Respiratory Depression
Increased end tidal carbon dioxide value (if measured) above 45 mmHg when previously within the normal range
and/or
≥5 breaths per minute decrease in respiratory rate from maximum post-reversal measurement, with a rate of at most 12 breaths per minute.
Measured: Up to 3 hours
ED Disposition
One of the following will apply:
- ED Discharge
- Hospital Admission
- ICU Admission
- Left against medical advice
- Transfer to another facility
- Death.
Measured: Up to 3 hours
Drug Dosing
- Dose administered for each opioid antagonist given to patients during their ED encounter -
- Individual dose amount and frequency
- Cumulative dose
- Any pre-hospital naloxone given prior to ED arrival -
- Dose amount, route
Measured: Up to 3 hours
Richmond-Agitation Sedation Scale (RASS) Score
This is a single-item instrument used to quickly assess the degree of patient alertness and agitation in emergency and critical care settings. It is an observational assessment conducted by healthcare providers, and it can be completed in seconds. The scale uses integers from -5 to +4, each with its own clear anchor. A score of 0 means that the patient is alert and calm. Negative integers indicate diminished responsiveness and consciousness, with -1 indicating that a patient will open their eyes or make eye contact for 10 or more seconds when awakened by voice, and -5 meaning that the patient is unarousable by voice or physical stimulation. Positive integers indicate an increased level of arousal or agitation. The positive end of the scale spans from +1 (anxious, apprehensive, but not aggressive) to +4 (combative, violent, danger to staff).
Measured: Up to 3 hours
Clinical Opioid Withdrawal Scale (COWS) Score
This is an observational assessment performed by a clinician to diagnose and assess the severity of opioid withdrawal symptoms. Eleven different opioid withdrawal symptoms are included in the COWS. The clinician will score the presence and severity of each symptom, with 0 indicating that the symptom is absent and more severe symptoms warranting a higher score. Individual symptom scores are then added to determine the overall severity of the patient's withdrawal. Total scores range from 5 to 48 where 5 - 12 = mild; 13 - 24 = moderate; 25 - 36 moderately severe; and greater than 36 = severe withdrawal.
Measured: Up to 3 hours
Oxygen saturation level
Pulse oximetry monitoring will be used to assess the patient's oxygen saturation level (SpO2), expressed as a percentage from 0 to 100.
Measured: Up to 3 hours
Length of time during ED encounter
Defined as the difference between time at Triage to time at ED Disposition
Measured: Up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: Due to changes in research objectives and methodological approach.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808881
- Sponsor's protocol ID
- NAL4001
- Acronym
- COINED
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
- ClinicalTrials.gov ID
- NCT05808881
- Acronym / sponsor ID
- COINED / NAL4001
- Conditions
- Opioid Overdose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to changes in research objectives and methodological approach.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 12 Apr 2023 (actual)
- 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.
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalmefene | Experimental | Drug: Nalmefene Hydrochloride InjectionNalmefene hydrochloride (HCl) injection |
| Naloxone | Active comparator | Drug: Naloxone Hydrochloride InjectionNaloxone hydrochloride (HCl) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presumed or known opioid overdose in community settings.
- Experiencing clinically significant respiratory depression based on appropriate medical judgement.
- Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
- Pre-hospital naloxone administration is allowed.
Key exclusion criteria (5 listed)
- Patient age known or estimated to be less than 18 years.
- Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
- Cardiac arrest, secondary to opioid intoxication.
- Arrested, jailed, or imprisoned patients.
- Inappropriate for the study per judgement of research team.
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 |
|---|---|---|
| Nalmefene Hydrochloride Injectionfor intravenous/intramuscular/subcutaneous (IV/IM/SC) administration | Drug | Nalmefene |
| Naloxone Hydrochloride InjectionAlso: Narcanfor intravenous/intramuscular/subcutaneous (IV/IM/SC) administration | Drug | Naloxone |
Primary outcome
Reversal of Respiratory Depression
Time frame: Up to 3 hours
Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg and/or ≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.
8 secondary outcomes
Time to Reversal from administration of opioid antagonist
Time frame: Up to 3 hours
Recurrence of Respiratory Depression
Time frame: Up to 3 hours
ED Disposition
Time frame: Up to 3 hours
Drug Dosing
Time frame: Up to 3 hours
Richmond-Agitation Sedation Scale (RASS) Score
Time frame: Up to 3 hours
Clinical Opioid Withdrawal Scale (COWS) Score
Time frame: Up to 3 hours
Oxygen saturation level
Time frame: Up to 3 hours
Length of time during ED encounter
Time frame: Up to 3 hours
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 12 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Opioid Overdose
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruiting
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Opioid Overdose (Trial 3 of 3)
Remote vs. In-Person, Remote Visits
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection in people with Opioid Overdose, run by Purdue Pharma LP.
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 4 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reversal of Respiratory Depression (time frame: Up to 3 hours). 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 12 Jul 2023.