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Methadone CBD for Opioid Use Disorder

Phase 2

Recruiting

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

Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum: 24mg/day), AND urinary toxicology positive for buprenorphine

Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum: 200mg/day), AND urinary toxicology positive for methadone and EDDP; OR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-weeks and 8-weeks

Awards & highlights

Study Summary

This trial is trying to find out if cannabidiol (CBD) can help reduce craving and relapse in people with opioid use disorder (OUD). The first part of the project was a

Who is the study for?

This trial is for individuals with opioid addiction who are currently on opioid agonist therapy. It aims to see if CBD can help reduce cravings and anxiety related to their condition.Check my eligibility

What is being tested?

The study tests two different doses of CBD (200mg and 400mg) against a placebo to determine its effectiveness in reducing craving and relapse in people with opioid use disorder.See study design

What are the potential side effects?

While the side effects of CBD at these doses aren't fully known, possible reactions may include tiredness, changes in appetite or weight, diarrhea, and interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a daily buprenorphine treatment between 8mg and 24mg, and my urine test was positive for buprenorphine.

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I am on a methadone treatment of 40-200mg/day and my urine test shows methadone and EDDP.

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I am between 18 and 65 years old.

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I understand the study and agree to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-weeks and 8-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-weeks and 8-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks and 8-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analog Scale for Craving (VASC)

Proportion of participants with positive urine toxicology

Systematic Assessment for Treatment Emergent Events (SAFTEE)

Secondary outcome measures

Change in Blood pressure

Change in Body Temperature

Change in Change in dosage of opioid agonist treatment

+22 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Methadone CBDActive Control2 Interventions

CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.

Group II: Buprenorphine CBDActive Control2 Interventions

CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.

Group III: Methadone PlaceboPlacebo Group2 Interventions

Matching placebo.in first dosing period and CBD 400mg in second dosing period

Group IV: Buprenorphine PlaceboPlacebo Group2 Interventions

Matching placebo.in first dosing period and CBD 400mg in second dosing period

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yasmin HurdLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

Yasmin Hurd, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

4 Previous Clinical Trials

423 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 potential risks associated with the combination of Methadone and CBD in patients?

"As a Phase 2 trial, there is limited data supporting the safety of Methadone CBD. Therefore, our team at Power rates it as a 2 on a scale from 1 to 3."

Answered by AI

Is it feasible for me to be a participant in this clinical investigation?

"To participate in this clinical trial, individuals must meet the criteria of having opioid use disorder and be between 18 and 65 years old. The study aims to enroll a total of 200 patients."

Answered by AI

Is the inclusion criteria for this research study open to individuals below 25 years of age?

"Potential participants sought for this study must be of legal age and under 65 years old."

Answered by AI

What is the current number of participants involved in this clinical study?

"Indeed, according to the information provided on clinicaltrials.gov, this study is presently seeking suitable candidates. The study was originally posted on October 4th, 2023 and recently updated on January 4th, 2024. A total of 200 patients are being sought from a single site for participation in this trial."

Answered by AI

Are patients currently being enrolled in this research study?

"According to the current information available on clinicaltrials.gov, this research study is actively seeking eligible participants. It was initially posted on October 4th, 2023 and underwent its most recent update on January 4th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cannabidiol for Opioid Addiction

Yasmin Hurd 2023. "Cannabidiol for Opioid Addiction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206291.

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