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AZD4041 and morphine for Opioid Use Disorder

Phase 1
Waitlist Available
Led By Debra Kelsh, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 54 days

Summary

This trial tests a new drug, AZD4041, combined with morphine in healthy recreational opioid users. The goal is to see if AZD4041 changes how morphine affects breathing. Up to 44 participants will be involved, and the study will last several weeks per person. Morphine has been extensively studied for its effects on breathing, pain relief, and other physiological responses.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~54 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 54 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of increased end tidal carbon dioxide (EtCO2)
Incidence of reduction in SpO2
Secondary study objectives
Amount of drug (AZD4041) excreted in urine
Apparent renal clearance of AZD4041 in urine
Apparent total clearance of the AZD4041 from plasma at steady state
+46 more

Side effects data

From 2015 Phase 4 trial • 84 Patients • NCT02009722
52%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD4041 and morphineExperimental Treatment1 Intervention
Participants will receive an IV dose of morphine on Days 1 and 15. From Days 2 to 15, participants will receive an oral dose of AZD4041 once daily.
Group II: Placebo and morphinePlacebo Group1 Intervention
Participants will receive an IV dose of morphine on Days 1 and 15. From Days 2 to 15, participants will receive an oral dose of placebo once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4041 and morphine
2022
Completed Phase 1
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,738,873 Total Patients Enrolled
Debra Kelsh, MDPrincipal InvestigatorAltasciences Company Inc.
13 Previous Clinical Trials
531 Total Patients Enrolled
~15 spots leftby Oct 2025
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