CSX-1004 for Opioid use disorder

Inclusion criteria

• {"criterion_text":"- Must provide written informed consent prior to the initiation of any protocol-specific procedures.\n- Male and female adults, between 18 and 55 years of age, inclusive.\n- Body mass index (BMI) within 18.0 to 32.0 kg/m², inclusive (minimum weight of at least 50.0 kg).\n- Must be medically stable, as determined by medical history, physical examination, ECG, and vital signs at Screening\n- Negative urine drug screen for fentanyl at Screening.\n- Is willing and able to comply with the study requirements, including clinic confinement and blood sampling.\n- Part B: Diagnosis of mild or moderate opioid use disorder (DSM-5-TR) and self-reported daily opioid use, defined as daily oral MME doses ≥30 to ≤120 mg for at least 3 months."}

Exclusion criteria

• {"criterion_text":"- History or presence of any clinically significant psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening.\n- Part A: History of or currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances (excluding caffeine).\n- Part B: Currently meets the criteria for a diagnosis of substance use disorder according to DSM-5-TR criteria for any substances, excluding opioids, caffeine, or nicotine.\n- Part B: History of or currently meets the criteria for a diagnosis of severe opioid use disorder.\n- Requires concomitant treatment with prohibited medications that cannot be safely discontinued prior to first drug administration."}

Primary endpoints

• {"endpoint_text":"- Peak change in MV (absolute and % [L/min]), calculated based on a 1-minute average of the ventilation data of each individual participant.","definition_or_measurement_approach":"Calculated based on a 1-minute average of the ventilation data of each individual participant (isohypercapnic minute ventilation)."}

Secondary endpoints

• {"endpoint_text":"- Peak change in respiratory rate [breaths/min], oxygen saturation (SpO2), tidal volume [L]","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of apnea (≥20 sec loss of respiratory activity)","definition_or_measurement_approach":"Apnea defined as ≥20 seconds loss of respiratory activity."}
• {"endpoint_text":"- Incidence of oxygen desaturation (<92%)","definition_or_measurement_approach":"Oxygen desaturation defined as SpO2 < 92%."}
• {"endpoint_text":"- Pupillometry (maximum pupil diameter)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Alertness/Drowsiness visual analog scale (VAS) (minimum effect [Emin])","definition_or_measurement_approach":"Measured by visual analog scale; report minimum effect (Emin)."}
• {"endpoint_text":"- Any Drug Effects VAS (maximum effect [Emax])","definition_or_measurement_approach":"Measured by visual analog scale; report maximum effect (Emax)."}
• {"endpoint_text":"- Drug Liking VAS (Emax)","definition_or_measurement_approach":"Measured by visual analog scale; report maximum effect (Emax)."}
• {"endpoint_text":"- High VAS (Emax)","definition_or_measurement_approach":"Measured by visual analog scale; report maximum effect (Emax)."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

4

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Cessation Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States