Clinical Outcomes From Nalmefene (COINED)

Purdue Pharma

Status and phase: Withdrawn; Phase 4

Conditions: Opioid Overdose

Treatments: Drug: Nalmefene Hydrochloride Injection; Drug: Naloxone Hydrochloride Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05808881

NAL4001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presumed or known opioid overdose in community settings.
2. Experiencing clinically significant respiratory depression based on appropriate medical judgement.
3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
4. Pre-hospital naloxone administration is allowed.

Exclusion criteria

1. Patient age known or estimated to be less than 18 years.
2. 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.
3. Cardiac arrest, secondary to opioid intoxication.
4. Arrested, jailed, or imprisoned patients.
5. Inappropriate for the study per judgement of research team.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Nalmefene

Experimental group

Description:

Nalmefene hydrochloride (HCl) injection

Treatment:

Drug: Nalmefene Hydrochloride Injection

Naloxone

Active Comparator group

Description:

Naloxone hydrochloride (HCl) injection

Treatment:

Drug: Naloxone Hydrochloride Injection