Frontlight ResearchEarly access
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