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Cannabinoid

CBD for Opioid Use Disorder

Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be 18 years of age or older
Be older than 18 years old
Must not have
Currently taking any of the following medications: Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide); Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate); Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year
Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 weeks, 6-12 weeks, 0-12 weeks, 0-16 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing if CBD can help reduce anxiety, pain, and the need for opioids while also improving sleep and cognitive function. It is double-blind, meaning neither the participants nor the researchers will know who is receiving the placebo and who is receiving CBD until the trial is over.

Who is the study for?
Adults with a desire to reduce pain or opioid use through cannabidiol (CBD) can join this study. Excluded are those using recreational drugs, heavy alcohol users, severe opioid addicts unless stable and approved by doctors, people treated for certain mental disorders within the last year, pregnant/nursing women not on birth control, and anyone with unstable medical conditions.
What is being tested?
The trial is testing two forms of CBD against a placebo to see if they help lower opioid use and relieve anxiety, pain while improving sleep and cognitive function. Participants will be randomly assigned one of these treatments for 12 weeks in a double-blind setup where neither they nor the researchers know who's getting what.
What are the potential side effects?
While specific side effects aren't listed here, CBD may cause fatigue, changes in appetite or weight, diarrhea, and could interact negatively with other medications. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking medications that interact with Epidiolex and have no recent severe mental health issues.
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I am not pregnant, nursing, or I am using reliable birth control.
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I am currently using CBD for health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 weeks, 6-12 weeks, 0-12 weeks, 0-16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 weeks, 6-12 weeks, 0-12 weeks, 0-16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in THC use
Reduction in pain
Reduction in pain medication use
Secondary study objectives
Change in Anandamide (AEA)
Change in inflammation
Change in opioid craving
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Broad-spectrum CannabidiolActive Control1 Intervention
210mg/day of broad-spectrum cannabidiol, containing 0%THC.
Group II: Full-spectrum CannabidiolActive Control1 Intervention
210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.
Group III: Hemp Seed Oil PlaceboPlacebo Group1 Intervention
210mg/day of hemp-seed oil with no cannabinoids present.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,256 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05299944 — Phase 2
Opioid Use Disorder Research Study Groups: Broad-spectrum Cannabidiol, Full-spectrum Cannabidiol, Hemp Seed Oil Placebo
Opioid Use Disorder Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05299944 — Phase 2
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299944 — Phase 2
~69 spots leftby Feb 2027
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