Clinical trial NCT05299944: Reducing Pain and Opioid Use With CBD
Official title: Reducing Pain and Opioid Use With CBD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Opioid Use Disorder
Keywords: Opioids
Pain
Cannabidiol
CBD
Cannabis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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, 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.

Study visits will take place both in-person and via Zoom/online. Study participants will attend four in-person visits at the University of Colorado Anschutz at Week 0 (Baseline Medical Director Screen and Medication Dispense), Week 6, and Week 12. Research staff will meet with participants over Zoom during their Week 1 visit and will be contacted weekly during the 12-week study period. Following the Week 1 Zoom visit, participants will have the option to receive the survey link via email for Weeks 2-5 and 7-11 in lieu of meeting with a research team member over Zoom to allow more flexibility in time to complete the study surveys (participants can complete surveys at their convenience within a 3-business day period). In Week 16, approximately 4 weeks after the end of dosing, a final follow-up Zoom interview will occur.

Eligibility 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.

Primary outcomes:
measure: Reduction in pain medication use
timeFrame: 0-12 Weeks
measure: Reduction in THC use
timeFrame: 0-12 Weeks
measure: Reduction in pain
timeFrame: 0-12 Weeks
Secondary outcomes:
measure: Change in opioid craving
timeFrame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
measure: Change in inflammation
timeFrame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
measure: Change in Anandamide (AEA)
timeFrame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
measure: Change in quality of life
timeFrame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
measure: Change in self-reported cognitive function
timeFrame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
measure: Reduction in anxiety
timeFrame: 0-12 Weeks
measure: Reduction in sleep disturbance / fatigue
timeFrame: 0-12 Weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
References: