Reducing pain and opioid use with CBD
This study is testing whether Full Spectrum CBD and Broad Spectrum CBD can help people with opioid use disorder reduce their pain and reliance on opioids over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | pexidartinib |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05299944 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a Phase II randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of Full Spectrum CBD (fsCBD) and Broad Spectrum CBD (bsCBD) in individuals with opioid use disorder. Participants will be randomly assigned to receive either fsCBD, bsCBD, or a placebo for a duration of 12 weeks. The study will assess outcomes related to opioid use reduction, anxiety, pain relief, sleep improvement, and cognitive function. Participants will attend a combination of in-person and online visits throughout the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a self-reported desire to use cannabidiol to alleviate pain and/or reduce opioid consumption.
Not a fit: Patients with a history of substance use disorders other than opioid use disorder or those currently undergoing treatment for other substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing pain and reducing reliance on opioids for patients with opioid use disorder.
How similar studies have performed: Other studies exploring the use of CBD for pain management and opioid reduction have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Self-reported desire or intent to use cannabidiol to reduce pain and/or opioid use 2. Must be 18 years of age or older. Exclusion Criteria: 1. 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; 2. 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); 3. Actively seeking or in treatment for or history of any substance use disorder, other than opioid use disorder; 4. 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; 5. Currently taking any of the following medications: 1. Those known to have a major interaction with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide) 2. Acute treatment with any antiepileptic medications (e.g. clobazam, sodium valproate) 6. Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year. 7. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. 8. Endorsing item 2 on the C-SSRS measure of suicide risk. 9. Currently using CBD for medical reasons.
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Raeghan Mueller
- Email: raeghan.mueller@cuanschutz.edu
- Phone: 302.724.2208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.