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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
Awards & highlights

Study Summary

This trial tests the effects of a drug (AZD4041) on respiratory drive when combined with morphine in healthy recreational opioid users. 44 participants will be randomly assigned to either the drug or placebo. Total study duration: 54 days.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of increased end tidal carbon dioxide (EtCO2)
Incidence of reduction in SpO2
Secondary outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,741 Total Patients Enrolled
Debra Kelsh, MDPrincipal InvestigatorAltasciences Company Inc.
12 Previous Clinical Trials
511 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the proposed objectives of this clinical investigation?

"This 54 day clinical trial will primarily measure the incidence of increased end tidal carbon dioxide (EtCO2). Additionally, it shall also assess Time of last measurable observed concentration of morphine and its metabolites (Tlast), Time to reach maximum (peak) plasma concentration of morphine and its metabolites (Tmax), as well as Predose concentration of AZD4041 observed immediately prior to the next successive dose (Ctrough)."

Answered by AI

To which demographic is participation in this trial accessible?

"This clinical trial is actively recruiting 36 individuals aged 18 to 55 with a history of recreational opioid use. To be eligible, patients must satisfy the criteria as outlined in DSM-5 for substance abuse disorder, provide signed informed consent prior to initiation of any protocol specific procedures and maintain availability throughout the course of study. Furthermore, BMI should fall between 18 kg/m2 and 35 kg/m2 with body weight exceeding 50kg at Screening; FSH levels ≥ 40 mIU/mL at Screening or have had hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy or bilateral tubal ligation"

Answered by AI

What potential dangers do AZD4041 and morphine pose to individuals receiving treatment?

"We have assigned a score of 1 to AZD4041 and morphine due to our team's assessment that there is only minimal data supporting their safety and efficacy."

Answered by AI

Does this medical research currently have openings for volunteers?

"Affirmative. As reported on clinicaltrials.gov, this research is actively searching for volunteers who meet its criteria. First posted in September of 2022 and recently updated in November, it's looking to enrol 36 individuals from a single site."

Answered by AI

Does the research protocol admit individuals over 40 years of age?

"The entrance requirements of this clinical trial state that participants must be between 18 to 55 years old. In comparison, there are 22 trials specifically for minors and 240 studies targeting seniors."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. Clinicaltrials.gov records suggest that this research project, which was originally posted on September 20th 2022, is currently recruiting test subjects. The study needs 36 volunteers from 1 medical centre to complete it's objectives."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
2022. "A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587998.
~18 spots leftby Apr 2025
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