At a glance
ClinicalIndex Comparison Record- ✓Recreational opioid user without moderate or severe opioid use disorder, with experience on at least 10 occasions lifetime and at least 1 occasion in last 12 weeks
- ✓Age 18-55 years
- ✓BMI 18.0-35.0 kg/m² and body weight ≥50 kg
- ✓Otherwise healthy with no clinically significant medical findings on physical exam, ECG, labs, and vital signs
- ✕Moderate or severe substance/alcohol use disorder (excluding nicotine/caffeine) in past 2 years
- ✕Significant psychiatric disorder that could affect safety or study interpretation
- ✕Hypersensitivity to AZD4041, morphine, opioids, naloxone, or excipients; severe hypersensitivity reactions
- ✕Significant hepatic, renal, cardiovascular, pulmonary, hematologic, neurological, gastrointestinal, endocrine, or immunologic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Fixed Sequence Study to Assess the Effect on Respiratory Drive of Multiple Doses of AZD4041 When Co-administered With a Single Dose of Morphine in Healthy Recreational Opioid Users
In Brief
A Phase 1 clinical trial evaluating Morphine, AZD4041, and 1 other intervention for Opioid Use Disorder. Completed, enrolled 45 participants across 1 site.
Detailed Summary
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users. This study is being primarily conducted to assess the effect on respiratory drive of morphine administered after multiple doses of AZD4041 compared to morphine administered alone in healthy recreational opioid users. The study will include up to 44 participants who will be randomized to either AZD4041 and morphine (28 participants) or placebo and morphine (16 participants). This is to ensure completion of at least 36 participants (24 AZD4041 + morphine, and 12 Placebo + morphine on Day 15). The total study duration will be up to 54 days (including screening) per participant.
Study Details
Timeline
Interventions
Participants will receive IV dose of Morphine as stated in arm description.
Participants will receive oral doses of AZD4041 as stated in arm description.
Participants will receive oral doses of placebo as stated in arm description.