AZD4041 and morphine for Opioid Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Overland Park, KSOpioid Use DisorderAZD4041 and morphine - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 49 Secondary · Reporting Duration: 54 days

16 days
Assess EtCO2 duration
Assess EtCO2 postdose
Assess EtCO2 postdose increase
Assess EtCO2 time
Incidence of increased end tidal carbon dioxide (EtCO2)
17 days
Predose concentration of AZD4041 observed immediately prior to the next successive dose
18 days
Apparent total clearance of the morphine and its metabolites from plasma
Area under the curve of morphine and its metabolites from time 0 to time t (AUC from zero to the last measurable concentration)
Extrapolation of the area under the curve of morphine and its metabolites from zero to infinity
Maximum (peak) plasma concentration of morphine and its metabolites
Terminal half-life of morphine and its metabolites
Brain Diseases, Metabolic
Time to reach maximum (peak) plasma concentration of morphine and its metabolites
Volume of distribution based on terminal phase of morphine and its metabolites
4 days
Amount of drug (AZD4041) excreted in urine
Apparent renal clearance of AZD4041 in urine
Cumulative fraction of unchanged drug (AZD4041) excreted in urine over the dosing interval
Elimination half-life of AZD4041
54 days
Assess SpO2 (%) duration
Assess SpO2 (%) postdose
Saturation of Peripheral Oxygen
Assess SpO2 (%) time
Assess respiratory rate duration
Assess respiratory rate incidence
Respiratory rate
Assess respiratory rate postdose decrease
Respiratory rate
Electrocardiogram HR
Electrocardiogram PR interval
Electrocardiogram QRS duration
Electrocardiogram QT interval
Electrocardiogram QTcF interval
Electrocardiogram RR interval
Incidence and severity of Adverse Events
Incidence of reduction in SpO2
Medical intervention used
Neurological examinations
Physical examinations
Safety clinical laboratory tests
Suicidal Behaviour
Suicidal Ideation
Vital signs (Blood pressure)
Heart rate
Vital signs (Temperature)
8 days
Apparent total clearance of the AZD4041 from plasma at steady state
Area under the concentration time curve over the dosing interval of AZD4041 at steady-state
Average concentration during a dosing interval, after the last dose of a multiple dose regimen of AZD4041
Maximum (peak) plasma concentration of AZD4041 at steady state
Terminal half-life of AZD4041
Time to reach maximum (peak) plasma concentration of AZD4041 at steady state
Volume of distribution based on terminal phase of AZD4041 at steady state

Trial Safety

Safety Progress

1 of 3

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1
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Side Effects for

Intrathecal Hydromorphone
66%Moderate to Severe Pruritus
32%Moderate to Severe Nausea
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02009722) in the Intrathecal Hydromorphone ARM group. Side effects include: Moderate to Severe Pruritus with 66%, Moderate to Severe Nausea with 32%.

Trial Design

2 Treatment Groups

AZD4041 and morphine
1 of 2
Placebo and morphine
1 of 2

Experimental Treatment

Non-Treatment Group

44 Total Participants · 2 Treatment Groups

Primary Treatment: AZD4041 and morphine · Has Placebo Group · Phase 1

AZD4041 and morphine
Drug
Experimental Group · 1 Intervention: AZD4041 and morphine · Intervention Types: Drug
Placebo and morphine
Other
PlaceboComparator Group · 1 Intervention: Placebo and morphine · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 54 days

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,017 Previous Clinical Trials
240,372,415 Total Patients Enrolled
Debra Kelsh, MDPrincipal Investigatoraltasciences
11 Previous Clinical Trials
491 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women who have not had their menstrual cycle for a year and do not have any other medical condition causing this.
Your FSH levels are too high (≥ 40 mIU/mL) during the screening process.
If you are a male, you must use effective birth control during sexual activity and not donate sperm during the study and for at least 4 months after completing the study medication.
You have used opioids for non-medical reasons at least 10 times in your life and at least once in the last 12 weeks, but you do not have a severe addiction to them according to the DSM-5 criteria.
You must sign and date the informed consent form before any study procedures can begin.
You agree to follow all study rules and be available for the entire study period.
You are a healthy adult between the ages of 18 and 55 and have not yet received the study drug.
Your weight and height make up a certain number called Body Mass Index (BMI) and it should be between 18 and 35. Also, you should weigh at least 50 kilograms.
You have had a surgery that made it impossible for you to get pregnant. If you have had such a surgery, you need to provide proof of the procedure through medical documentation.
The doctors have examined you and found that you are healthy based on your medical history, physical exam, ECG, vital signs, oxygen levels, and lab test results before starting the study.
References

Frequently Asked Questions

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)." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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