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Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity
EU CTIS ID: 2023-505338-93-00
What this study is testing
The number IM and IN administrations needed to restore ventilation to baseline levels in healthy volunteers
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 18-65 years with body mass index 19-40 kg/m2
- Opioid users: use opioids at daily doses ≥ 60 mg oral morphine equivalents. . No upper limit is set as would like to study an as large as possible range of opioid use. It is our experience that the majority of patients uses 60-600 mg oral morphine equivalents.
- Opioid users: • Stable as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, 12-lead ECG, hematology, and blood chemistry.
You likely can't join if
- A medical history of medical or psychiatric disease (incl. drug or alcohol addiction);
- • Pregnancy or lactation
- • A positive drug urine dipstick on the screening or study days
- • History or presence of allergic response to study medication
- for chronic opioid users: • Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;
- Chronic opioid users: Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
See the full eligibility criteria
- Aged 18-65 years with body mass index 19-40 kg/m2
- Opioid users: use opioids at daily doses ≥ 60 mg oral morphine equivalents. . No upper limit is set as would like to study an as large as possible range of opioid use. It is our experience that the majority of patients uses 60-600 mg oral morphine equivalents.
- Opioid users: • Stable as defined by the Investigator, based on a medical evaluation that includes the subject’s medical and surgical history, physical examination, vital signs, 12-lead ECG, hematology, and blood chemistry.
- A medical history of medical or psychiatric disease (incl. drug or alcohol addiction);
- • Pregnancy or lactation
- • A positive drug urine dipstick on the screening or study days
- • History or presence of allergic response to study medication
- for chronic opioid users: • Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;
- Chronic opioid users: Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
- Chronic opioid users: Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;
- Treatment with mixed agonists-antagonists (such as buprenorphine) or use of benzodiazepines.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.