Using L-NAC to reverse breathing problems caused by opioid medication

L-NAC (N-acetyl-N-cysteine or fluimicil) for reversal of opioid-induced respiratory depression

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16683564

Enrollment

Registered

2023-05-31

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversal of opioid-induced respiratory depression Signs and Symptoms

Interventions

Randomization (1:1) will be done by generating an electronic randomization list in R by an independent member of the department and sent to the pharmacy. The pharmacy is responsible for blinding the L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 40 years 2. Body mass index 19-30 kg/m² 3. Ability to read and understand the subject information in the Dutch language

Exclusion criteria

Exclusion criteria: 1. A medical history of medical or psychiatric disease; 2. Any allergy to food or medication; 3. Weekly ethanol intake of more than 3 units/day or more than 21 units/week in women and 5 units/day and 35 units/week in men; 4. Pregnancy; 5. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative urine pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug; Acceptable means of contraception include: hormonal methods (birth control pills), barrier 6. Methods (condoms, diaphragm), intrauterine devices, sterilization; 7. Participation in an investigational drug trial in the 3 months before the current study; 8. Illicit drug use in the 30 days before the current study; 9. A positive drug urine dipstick on the screening or study days, including benzodiazepines.

Design outcomes

Primary

Measure	Time frame
Minute ventilation during exposure measured through a facemask during the exposure period	—

Secondary

Measure	Time frame
1. End-tidal carbon dioxide partial pressure obtained on a breath-to-breath basis during the exposure period using pneumotachograph 2. Respiratory frequency obtained on a breath-to-breath basis during the exposure period using pneumotachograph 3. Tidal volume obtained on a breath-to-breath basis during the exposure period using pneumotachograph 4. Arterial blood gas analysis: pH, pO2, pCO2, oxygen saturation obtained at 15 min intervals during the exposure period using blood gas analyzer 5. Plasma concentrations of fentanyl and L-NAC measured using a blood sample at regular intervals using LC-MS/MS methods 6. Blood pressure measured by cuff (at 30 min interval) during the exposure period	—

Measure

Time frame

1. End-tidal carbon dioxide partial pressure obtained on a breath-to-breath basis during the exposure period using pneumotachograph 2. Respiratory frequency obtained on a breath-to-breath basis during the exposure period using pneumotachograph 3. Tidal volume obtained on a breath-to-breath basis during the exposure period using pneumotachograph 4. Arterial blood gas analysis: pH, pO2, pCO2, oxygen saturation obtained at 15 min intervals during the exposure period using blood gas analyzer 5. Plasma concentrations of fentanyl and L-NAC measured using a blood sample at regular intervals using LC-MS/MS methods 6. Blood pressure measured by cuff (at 30 min interval) during the exposure period

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026