Reducing Pain and Opioid Use With CBD

  • STATUS
    Recruiting
  • End date
    Feb 21, 2027
  • participants needed
    150
  • sponsor
    University of Colorado, Denver
Updated on 21 April 2022

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 pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

Description

To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of opioid users.

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 pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be in-person visits at Weeks 1, 6, and 12. Participants will be contacted by Zoom each remaining week during the 12-week period. A follow up Zoom interview will occur in Week 16, approximately 4 weeks after the end of dosing.

Details
Condition Opioid Use Disorder
Treatment Placebo, Cannabidiol
Clinical Study IdentifierNCT05299944
SponsorUniversity of Colorado, Denver
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use
Must be 18 years of age or older

Exclusion Criteria

Self-reported recreational drug use (other than opioids) in the past 30 days or failed urine screen for cocaine, benzodiazepines, 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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