Status:
COMPLETED
Reducing Pain and Opioid Use With CBD
Lead Sponsor:
University of Colorado, Denver
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and ...
Detailed Description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, a...
Eligibility Criteria
Inclusion
- Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
- Must be 18 years of age or older.
Exclusion
- Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines (if not prescribed), MDMA, sedatives, or methamphetamine;
- Self-reported current moderate/severe alcohol use, or severe opioid use disorder on the DSM V (unless patient is medically stable and approved by personal physician as well as the Medical Director for the study);
- Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder;
- Currently being treated for or diagnosed with a moderate, severe, or unstable medical illness (e.g., renal disease, liver disease, cardiovascular disease). If the person has had a recent operation, they must be cleared for study participation by their surgeon or primary care doctor. Study inclusion/exclusion will be evaluated by our medical director when there are questions about applying criteria;
- 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.
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Currently using CBD for medical reasons.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05299944
Start Date
March 8 2022
End Date
August 19 2025
Last Update
December 12 2025
Active Locations (2)
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1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
University of Colorado Denver
Aurora, Colorado, United States, 80045