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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in opioid consumption, opioid craving, pain, peripheral markers of inflammation, and anxiety, as well as changes in sleep, AEA, and cognition.
Placebo arm
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado Denver
Aurora, Colorado, United States
Reduction in pain medication use
The Time Line Follow Back is a calendar-assisted measure that can be used to assess pain medication use. The investigators will use this measure to create the pain medication use variable. For opioids users, changes in opioid use will be assessed. For non-opioid users, non-opioid pain medication will be assessed.
Time frame: 0-12 Weeks
Reduction in THC use
The Timeline Follow-back will be used to quantify and frequency of THC use.
Time frame: 0-12 Weeks
Reduction in pain
-The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a will be used to measure pain intensity with a one question item over the past 7 days. Higher scores indicate more pain. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities. Higher scores indicate greater pain interference.
Time frame: 0-12 Weeks
Change in opioid craving
The Opioid Craving Scale will be used to assess changes in craving over time. This scale has three questions assessed using a 10-pt likert scale. Higher scores (0-30) indicate greater opioid craving.
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in inflammation
Differences in inflammatory markers (e.g. IL-6) will be assessed over time as a moderating factor.
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in Anandamide (AEA)
Differences in AEA will be assessed over time as a moderating factor.
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Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in quality of life
Changes in subjective quality of life will be assessed using the PROMIS Global-10 Short Form). Scores range from 10-50, with higher scores indicating poorer quality of life.
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Change in self-reported cognitive function
Changes in self-reported cognitive function will be assessed using the FACT-Cog. There are 37 questions on a 5-pt likert scale with higher scores indicating poorer cognition.
Time frame: 0-6 Weeks, 6-12 Weeks, 0-12 Weeks, 0-16 Weeks
Reduction in anxiety
The Depression Anxiety Stress Scale measures the severity of anxiety symptoms. Possible scores range from 0 to 41 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
Time frame: 0-12 Weeks
Reduction in sleep disturbance / fatigue
* The PROMIS Short Form v1.0 - Sleep Disturbance - 4A measure the severity of sleep disturbances. Possible scores range from 0 to 4 with lower scores indicating a worse outcome/more severe symptoms of sleep disturbance/fatigue. * The PROMIS Short Form v1.0 - Fatigue - 4a measures subject fatigue over the past 7 days on a 4 point scale, with higher scores indicating more fatigue.
Time frame: 0-12 Weeks