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Cannabinoid

Cannabidiol for Opioid Use Disorder

Phase 1
Waitlist Available
Led By Yasmin Hurd, PhD
Research Sponsored by Yasmin Hurd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours post-treatment
Awards & highlights

Study Summary

This trial is testing if CBD is safe and affects the body in healthy people.

Who is the study for?
This trial is for individuals aged 18-65 with opioid use disorder who are healthy, medication-free, and not using any psychoactive drugs. They must understand English and give informed consent. Pregnant or breastfeeding individuals, those on certain medications or with a history of significant health issues like heart disease or seizures cannot participate.Check my eligibility
What is being tested?
The study is testing whether cannabidiol (CBD) can help reduce cravings and anxiety in people with opioid addiction who are already on opioid agonist therapy. Participants will either receive CBD or a placebo to assess the effectiveness of CBD as an additional treatment option.See study design
What are the potential side effects?
While the specific side effects of CBD in this context aren't detailed here, common ones may include tiredness, changes in appetite, gastrointestinal issues, and potential interactions with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration curve (AUC)
Peak Plasma Concentration (Cmax)
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Secondary outcome measures
Area under the urine concentration curve (AUC)
Peak urine concentration of CBD (Umax)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard MealExperimental Treatment4 Interventions
Participants taking a standard meal.
Group II: High Fat MealExperimental Treatment4 Interventions
Participants taking a high fat meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol 200mg
2022
Completed Phase 1
~200
Cannabidiol 400mg
2022
Completed Phase 1
~200
Epidiolex
2020
Completed Phase 2
~380
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yasmin HurdLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Hurd,Yasmin, Ph.D.Lead Sponsor
5 Previous Clinical Trials
257 Total Patients Enrolled
Yasmin Hurd, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
423 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05269706 — Phase 1
Opioid Use Disorder Research Study Groups: Standard Meal, High Fat Meal
Opioid Use Disorder Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05269706 — Phase 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269706 — Phase 1
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05269706 — Phase 1

Frequently Asked Questions

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

How many participants are currently engaged in this research initiative?

"Affirmative, the details listed on clinicaltrials.gov attest to this medical trial's continued recruitment of patients. It was initially announced on May 18th 2022 and has since been revised November 28th 2022. Currently 24 participants are sought from 1 location."

Answered by AI

Is there an opportunity for me to partake in this experiment?

"This experiment requires 24 participants aged 18-65 with robust health. Criteria for inclusion include: comprehension of informed consent, English language fluency, healthy physical/psychological history and laboratory values, abstention from drugs or nicotine use, and sex as a biological variable (50% female recruitment)."

Answered by AI

Are there any slots left in this clinical research for new participants?

"According to current information on clinicaltrials.gov, this research is recruiting participants as of now. The initial posting date was May 18th 2022 and the most recent update occurred November 28th 2022."

Answered by AI

Has the FDA sanctioned Cannabidiol for therapeutic use?

"Considering that this is a Phase 1 clinical trial, with limited evidence regarding its safety and efficacy, Cannabidiol scored a 1 on our team's scale."

Answered by AI

Does this research encompass individuals of advanced age?

"This study is designed for adults aged between 18 and 65. There are, however, 50 trials available to those younger than this set age range and 372 studies targeting senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
California
Ohio
New York
How old are they?
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Just curious. Also, I have been under some stress. I'm interesting in advancing research efforts of cannabidiol and its family of compounds.
PatientReceived no prior treatments
Yes I'm extremely interested in this study as well as other healthy one's.i come to new York a lot .I have done long studies be for in as well as our patient visits.
PatientReceived 1 prior treatment
Yes I'm extremely interested in this study as well as other healthy one's.i come to new York a lot .I have done long studies be for in as well as our patient visits .Yes I can travel to new York.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Approximately when would this trial begin?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Cannabidiol in the Treatment of Opioid Use Disorder
Yasmin Hurd 2022. "Cannabidiol in the Treatment of Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05269706.
~69 spots leftby Apr 2025
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