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CompletedPhase 2

Reducing Pain and Opioid Use With CBD

Key facts

Who runs it
University of Colorado, Denver
Where
Aurora, United StatesSee the 2 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
126 people enrolled
Started
8 Mar 2022
Ended
19 Aug 2025
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cannabidiol
  • Placebo
Record updated
12 December 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

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

Who cannot take part

  • 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
  • Currently using CBD for medical reasons
  • 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
  • Report being treated for bipolar disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder in the last year
  • 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)
  • 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

Where in United States

  • University of Colorado Anschutz Medical CampusAurora, United States
  • University of Colorado DenverAurora, United States

About the trial

What the trial wants to find out

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 3 groups in the trial

  • Full-spectrum CannabidiolExisting treatment, for comparison

    210mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.

    Treatment: Cannabidiol

  • Broad-spectrum CannabidiolExisting treatment, for comparison

    210mg/day of broad-spectrum cannabidiol, containing 0%THC.

    Treatment: Cannabidiol

  • Hemp Seed Oil PlaceboPlacebo, for comparison

    210mg/day of hemp-seed oil with no cannabinoids present.

    Treatment: Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
12 December 2025