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CBD for Opioid Use Disorder
Phase 2
Recruiting
Led By Richard De La Garza, II, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On a stable dose of 12-16 mg buprenorphine, either alone, or in combination with naloxone (buprenorphine/naloxone ratio of 4/1) for at least 7 days prior to starting and for the duration of the treatment phase of the study
Body Mass Index (BMI) between 17.5 and 35 kg/m2; total body weight > 110 lb (50 kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before dosing (day 0) and during the treatment (days 3,7,14,21 and 28) and during the follow-up period (days 35,42,49 and 56).
Awards & highlights
Study Summary
This trial is testing whether cannabidiol (CBD) is an effective and safe treatment for patients with Opioid Use Disorder who are also taking buprenorphine + naloxone.
Who is the study for?
Adults aged 18-65 with Opioid Use Disorder, stable on buprenorphine + naloxone or methadone, and in residential treatment can join. They must not have used CBD recently, be free of certain medical conditions (like severe liver issues), not pregnant or breastfeeding, and willing to use birth control if applicable.Check my eligibility
What is being tested?
The trial tests whether CBD (600 mg daily) helps prevent relapse in opioid addiction as an add-on to standard treatments. Participants will either receive CBD or a placebo for four weeks while their craving levels and mood symptoms are monitored through questionnaires and drug tests.See study design
What are the potential side effects?
CBD may cause mild side effects such as tiredness, diarrhea, changes in appetite/weight. However, it's generally well-tolerated; specific side effects related to this study aren't listed but would be monitored by the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of buprenorphine (12-16 mg) for at least 7 days.
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My BMI is between 17.5 and 35, and I weigh more than 110 lb.
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I am between 18 and 65 years old.
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I am using or willing to use birth control or abstain from sex during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the laboratory session before dosing on day 0 (baseline without cbd) and on days 7 and 28 after adjunctive treatment with cbd.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the laboratory session before dosing on day 0 (baseline without cbd) and on days 7 and 28 after adjunctive treatment with cbd.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety will also be assessed via measurement of plasma levels of CBD as well as its metabolites 7-hydoxy-CBD and 7-carboxy-CBD.
Safety will also be assessed via measurement of plasma levels of anandamide and 2 AG.
Safety will also be assessed via measurement of plasma levels of buprenorphine and metabolites (norbuprenorphine and buprenorphine glucuronide).
+1 moreSecondary outcome measures
The extent to which CBD reduces cue-induced craving for opioids
Other outcome measures
Percentage of patients who relapse during the trial
Positive and Negative Affect Schedule (PANAS)
Spielberger State-Trait Anxiety Inventory
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Cannabidiol (CBD) 600 mgActive Control1 Intervention
Thirty participants who meet all eligibility criteria will be randomized to receive CBD (ATL5; Ananda Scientific) at a dose of 600 mg.
Group II: PlaceboPlacebo Group1 Intervention
Thirty participants who meet all eligibility criteria will be randomized to receive placebo.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,791 Total Patients Enrolled
Richard De La Garza, II, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
113 Total Patients Enrolled
Edythe London, PhDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
58 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have major heart, blood, liver, kidney, or hormone-related health issues.I have a condition that could affect how my body absorbs medication.I am currently on medication-assisted treatment with methadone or naltrexone.You have had an allergic reaction to a CBD product or any of the ingredients in the study drug, such as glycerin or gelatin.You rely on alcohol or certain medications to feel normal or calm.I am not on medications that interact badly with CBD.I am HIV positive or have AIDS.You have been diagnosed with conditions like schizophrenia, bipolar disorder, or a psychotic disorder. If you have had thoughts of hurting yourself or have attempted suicide in the past year, you will not be able to participate. However, if you have other mental health conditions like depression or anxiety, but are stable, you may still be eligible.My hormone levels are abnormal and I have unusual findings on my ovarian ultrasound.I have been on a stable dose of buprenorphine (12-16 mg) for at least 7 days.You have had a significant problem with substance abuse, except for opioid use disorder or tobacco use disorder, within the past 3 months.My screening tests show I have used CBD.You are experiencing severe symptoms of opioid withdrawal, as determined by a score higher than 4 on the COWS scale.You have reported using CBD (cannabidiol) before the screening.My BMI is between 17.5 and 35, and I weigh more than 110 lb.I am between 18 and 65 years old.I am using or willing to use birth control or abstain from sex during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol (CBD) 600 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can Cannabidiol Oral Solution (CBD) be considered a risk to human health?
"CBD Oral Solution has some safety data associated with it, so we assign a score of 2. However, the efficacy is still largely untested and requires further study."
Answered by AI
Are elderly individuals being allowed to partake in this clinical experiment?
"This clinical trial is open to any patient aged eighteen and above, up until the point of sixty-five."
Answered by AI
How many participants are actively engaged in this research endeavor?
"Yes, research on clinicaltrials.gov indicates that this study is actively recruiting participants. The original announcement was posted on May 19th 2022 and there has been a recent update as of May 23rd 2022. This trial requires 60 patients from 1 medical centre to enroll."
Answered by AI
What other studies involving Cannabidiol Oral Solution (CBD) have been successfully completed?
"At present, 79 clinical trials are underway for Cannabidiol Oral Solution (CBD). Of those studies 16 have reached the advanced Phase 3 stages. While most of the research is occurring in Ribeirao Preto, Sao Paulo there are 290 sites globally researching this medication."
Answered by AI
Are admissions for this experiment still being accepted?
"According to clinicaltrials.gov, the medical trial is currently in search of volunteers; having been initially uploaded on May 19th 2022 and last revised five days later."
Answered by AI
Who meets the requirements for inclusion in this trial?
"To be accepted, potential participants must have the specified condition and lie within an age range of 18 to 65. The team aims to recruit a total of 60 patients for this trial."
Answered by AI
What objectives is this research endeavor endeavoring to attain?
"This trial aims to measure safety over a given timeline by measuring plasma levels of buprenorphine and its metabolites. Secondary objectives include assessing treatment retention, blood pressure, and respiratory rate during the course of the study. Baseline measurements without CBD will be taken on Day 0 with follow-up assessments scheduled for Days 7 and 28 after adjunctive treatment with CBD."
Answered by AI
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