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Opioid Analgesic
Morphine Sulfate for Opioid Use Disorder
Phase 1
Recruiting
Research Sponsored by National Institute on Drug Abuse (NIDA)
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 7 + 3/5 days
Awards & highlights
Study Summary
This trial looks at how CBD affects the body when taken with morphine.
Who is the study for?
This trial is for adults aged 18-55 who use opioids recreationally but aren't seeking treatment for addiction. Participants must be in good health, not have significant medical conditions, and agree to avoid alcohol, caffeine-rich drinks, and strenuous exercise before the study. Women must use certain contraceptives or be non-childbearing.Check my eligibility
What is being tested?
The study investigates how CBD affects the body when taken with morphine. It aims to understand if CBD changes how morphine works in people who occasionally use opioids recreationally.See study design
What are the potential side effects?
Potential side effects are not detailed here; however, both CBD and morphine can cause drowsiness, dizziness, nausea, vomiting, constipation among other symptoms. Specific side effects related to their interaction will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 + 3/5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 + 3/5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the Area Under the Curve (AUC 0-t) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Establish the Area Under the Curve from zero to infinity (AUC 0-inf) of morphine and its 2 glucuronide conjugates when morphine is administered with and without CBD
Establish the Maximum Plasma Concentration (Cmax) of morphine when administered orally with and without CBD
Secondary outcome measures
Establish the Apparent Clearance of CBD when administered orally with morphine
Establish the Apparent Clearance of morphine when administered orally with and without CBD
Establish the Area Under the Curve of the dosing period of CBD when administered orally with morphine
+7 moreTrial Design
2Treatment groups
Active Control
Group I: CBD (350 mg)Active Control1 Intervention
CBD 350 mg twice per day for 3 days
Group II: CBD (700 mg)Active Control1 Intervention
CBD 700 mg twice per day for 3 days
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)Lead Sponsor
2,468 Previous Clinical Trials
2,619,288 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a healthy weight and are not underweight or extremely overweight.You are between the ages of 18 and 55 years.Please contact the study site directly to obtain more information.You are sexually active and use an acceptable method of contraception.
Research Study Groups:
This trial has the following groups:- Group 1: CBD (350 mg)
- Group 2: CBD (700 mg)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05143424 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
Alta Sciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Ptsd has controlled my life for the past 8 years, I constantly have flashbacks that trigger detachment from any surrounding/environment.
PatientReceived 2+ prior treatments
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